Live attenuated flu vaccine gets ACIP nod for 2018-2019 season

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The latest seasonal influenza vaccine recommendations from the Advisory Committee on Immunization Practices provide several key updates that will impact clinical practice in the 2018-2019 influenza season.

CAP53/iStockphoto.com

Of note, live attenuated influenza vaccine (LAIV; FluMist Quadrivalent) is an option, following two seasons in which the committee recommended it not be used.

ACIP also updated its recommendations for individuals with a history of egg allergy, described the vaccine strains chosen for 2018-2019 season, and detailed the changes in age indications for Afluria Quadrivalent and Fluarix Quadrivalent that have been made since publication of its previous guidelines.

Published in MMWR Recommendations and Reports, the updated ACIP recommendations reflect discussions and decisions from the three public meetings of ACIP that have taken place since the last annual update.

All individuals 6 months of age and older who have no contraindications to influenza vaccine should receive routine annual influenza vaccine, ACIP also said in its report, reinforcing a key recommendation that has been in place since 2010.

“To avoid missed opportunities for vaccination, providers should offer vaccination during routine health care visits and hospitalizations,” wrote authors of the report, including lead author Lisa A. Grohskopf, MD, of the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta.

Dr. Grohskopf and coauthors made no specific recommendations on which vaccine to use. They said providers should choose licensed, age-appropriate recommended vaccines expected to be available for the 2018-2019 season, including inactivated influenza vaccines (IIV), a recombinant influenza vaccine (RIV4), and the LAIV option.

FluMist Quadrivalent, the one LAIV product expected to be available for the 2018-2019 season, is licensed for individuals aged 2-49 years.

In its deliberations over the updated LAIV recommendation, ACIP reviewed observational data from previous seasons suggesting that the vaccine was poorly effective, and significantly less effective than IIV, against influenza A(H1N1) pdm09 viruses.

The current formulation of FluMist includes a new H1N1pdm09-like vaccine virus. While no effectiveness estimates were available at the time of review, ACIP said it did consider manufacturer data on shedding and immunogenicity for the current vaccine in children between the ages of 24 months through less than 4 years.

“These data suggest that this new H1N1pdm09-like virus has improved replicative fitness over previous H1N1pdm09-like viruses included in LAIV,” Dr. Grohskopf and colleagues wrote.

Individuals with an egg allergy history also can receive any licensed, recommended, age-appropriate IIV, RIV, or LAIV vaccine, said ACIP. This updated recommendation was based in part on the committee’s review and discussion of three studies that showed no cases of anaphylaxis in egg-allergic children receiving LAIV.

The ACIP recommendation update also outlines the strains selected earlier this year for the 2018-2019 season. Trivalent influenza vaccines in the United States will include an A/Michigan/45/2015 (H1N1) pdm09–like virus, an A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus, and a B/Colorado/06/2017–like virus (Victoria lineage). Quadrivalent vaccines will include those strains plus a B/Phuket/3073/2013–like virus (Yamagata lineage).

The report also acknowledges the recent expansion of age indication for two vaccines that have occurred since the last ACIP recommendations.

Afluria Quadrivalent was previously licensed for individuals 18 years of age and older. In August 2017, the Food and Drug Administration approved expansion of the indication to individuals 5 years of age or older. In January 2018, FDA approved expansion of the Fluarix Quadrivalent indication, previously licensed for age 3 and older, to individuals 6 months and older.

Report coauthor Emmanuel B. Walter disclosed grants from Novavax and Merck. The remaining report authors reported no relevant financial disclosures.

SOURCE: Grohskopf LA et al. MMWR Recomm Rep. 2018 Aug 24;67(3):1-20.

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The latest seasonal influenza vaccine recommendations from the Advisory Committee on Immunization Practices provide several key updates that will impact clinical practice in the 2018-2019 influenza season.

CAP53/iStockphoto.com

Of note, live attenuated influenza vaccine (LAIV; FluMist Quadrivalent) is an option, following two seasons in which the committee recommended it not be used.

ACIP also updated its recommendations for individuals with a history of egg allergy, described the vaccine strains chosen for 2018-2019 season, and detailed the changes in age indications for Afluria Quadrivalent and Fluarix Quadrivalent that have been made since publication of its previous guidelines.

Published in MMWR Recommendations and Reports, the updated ACIP recommendations reflect discussions and decisions from the three public meetings of ACIP that have taken place since the last annual update.

All individuals 6 months of age and older who have no contraindications to influenza vaccine should receive routine annual influenza vaccine, ACIP also said in its report, reinforcing a key recommendation that has been in place since 2010.

“To avoid missed opportunities for vaccination, providers should offer vaccination during routine health care visits and hospitalizations,” wrote authors of the report, including lead author Lisa A. Grohskopf, MD, of the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta.

Dr. Grohskopf and coauthors made no specific recommendations on which vaccine to use. They said providers should choose licensed, age-appropriate recommended vaccines expected to be available for the 2018-2019 season, including inactivated influenza vaccines (IIV), a recombinant influenza vaccine (RIV4), and the LAIV option.

FluMist Quadrivalent, the one LAIV product expected to be available for the 2018-2019 season, is licensed for individuals aged 2-49 years.

In its deliberations over the updated LAIV recommendation, ACIP reviewed observational data from previous seasons suggesting that the vaccine was poorly effective, and significantly less effective than IIV, against influenza A(H1N1) pdm09 viruses.

The current formulation of FluMist includes a new H1N1pdm09-like vaccine virus. While no effectiveness estimates were available at the time of review, ACIP said it did consider manufacturer data on shedding and immunogenicity for the current vaccine in children between the ages of 24 months through less than 4 years.

“These data suggest that this new H1N1pdm09-like virus has improved replicative fitness over previous H1N1pdm09-like viruses included in LAIV,” Dr. Grohskopf and colleagues wrote.

Individuals with an egg allergy history also can receive any licensed, recommended, age-appropriate IIV, RIV, or LAIV vaccine, said ACIP. This updated recommendation was based in part on the committee’s review and discussion of three studies that showed no cases of anaphylaxis in egg-allergic children receiving LAIV.

The ACIP recommendation update also outlines the strains selected earlier this year for the 2018-2019 season. Trivalent influenza vaccines in the United States will include an A/Michigan/45/2015 (H1N1) pdm09–like virus, an A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus, and a B/Colorado/06/2017–like virus (Victoria lineage). Quadrivalent vaccines will include those strains plus a B/Phuket/3073/2013–like virus (Yamagata lineage).

The report also acknowledges the recent expansion of age indication for two vaccines that have occurred since the last ACIP recommendations.

Afluria Quadrivalent was previously licensed for individuals 18 years of age and older. In August 2017, the Food and Drug Administration approved expansion of the indication to individuals 5 years of age or older. In January 2018, FDA approved expansion of the Fluarix Quadrivalent indication, previously licensed for age 3 and older, to individuals 6 months and older.

Report coauthor Emmanuel B. Walter disclosed grants from Novavax and Merck. The remaining report authors reported no relevant financial disclosures.

SOURCE: Grohskopf LA et al. MMWR Recomm Rep. 2018 Aug 24;67(3):1-20.

 

The latest seasonal influenza vaccine recommendations from the Advisory Committee on Immunization Practices provide several key updates that will impact clinical practice in the 2018-2019 influenza season.

CAP53/iStockphoto.com

Of note, live attenuated influenza vaccine (LAIV; FluMist Quadrivalent) is an option, following two seasons in which the committee recommended it not be used.

ACIP also updated its recommendations for individuals with a history of egg allergy, described the vaccine strains chosen for 2018-2019 season, and detailed the changes in age indications for Afluria Quadrivalent and Fluarix Quadrivalent that have been made since publication of its previous guidelines.

Published in MMWR Recommendations and Reports, the updated ACIP recommendations reflect discussions and decisions from the three public meetings of ACIP that have taken place since the last annual update.

All individuals 6 months of age and older who have no contraindications to influenza vaccine should receive routine annual influenza vaccine, ACIP also said in its report, reinforcing a key recommendation that has been in place since 2010.

“To avoid missed opportunities for vaccination, providers should offer vaccination during routine health care visits and hospitalizations,” wrote authors of the report, including lead author Lisa A. Grohskopf, MD, of the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta.

Dr. Grohskopf and coauthors made no specific recommendations on which vaccine to use. They said providers should choose licensed, age-appropriate recommended vaccines expected to be available for the 2018-2019 season, including inactivated influenza vaccines (IIV), a recombinant influenza vaccine (RIV4), and the LAIV option.

FluMist Quadrivalent, the one LAIV product expected to be available for the 2018-2019 season, is licensed for individuals aged 2-49 years.

In its deliberations over the updated LAIV recommendation, ACIP reviewed observational data from previous seasons suggesting that the vaccine was poorly effective, and significantly less effective than IIV, against influenza A(H1N1) pdm09 viruses.

The current formulation of FluMist includes a new H1N1pdm09-like vaccine virus. While no effectiveness estimates were available at the time of review, ACIP said it did consider manufacturer data on shedding and immunogenicity for the current vaccine in children between the ages of 24 months through less than 4 years.

“These data suggest that this new H1N1pdm09-like virus has improved replicative fitness over previous H1N1pdm09-like viruses included in LAIV,” Dr. Grohskopf and colleagues wrote.

Individuals with an egg allergy history also can receive any licensed, recommended, age-appropriate IIV, RIV, or LAIV vaccine, said ACIP. This updated recommendation was based in part on the committee’s review and discussion of three studies that showed no cases of anaphylaxis in egg-allergic children receiving LAIV.

The ACIP recommendation update also outlines the strains selected earlier this year for the 2018-2019 season. Trivalent influenza vaccines in the United States will include an A/Michigan/45/2015 (H1N1) pdm09–like virus, an A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus, and a B/Colorado/06/2017–like virus (Victoria lineage). Quadrivalent vaccines will include those strains plus a B/Phuket/3073/2013–like virus (Yamagata lineage).

The report also acknowledges the recent expansion of age indication for two vaccines that have occurred since the last ACIP recommendations.

Afluria Quadrivalent was previously licensed for individuals 18 years of age and older. In August 2017, the Food and Drug Administration approved expansion of the indication to individuals 5 years of age or older. In January 2018, FDA approved expansion of the Fluarix Quadrivalent indication, previously licensed for age 3 and older, to individuals 6 months and older.

Report coauthor Emmanuel B. Walter disclosed grants from Novavax and Merck. The remaining report authors reported no relevant financial disclosures.

SOURCE: Grohskopf LA et al. MMWR Recomm Rep. 2018 Aug 24;67(3):1-20.

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Russian Twitter bots and trolls amplify vaccine controversy

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Russian trolls and bots significantly intensified the polarization of vaccine messaging on Twitter, fostering discord on the social network, according to researchers who analyzed the content of tweets over a 3-year period.

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“Bots and trolls are actively involved in the online public health discourse, skewing discussions about vaccination,” wrote David A. Broniatowski, PhD, of George Washington University, Washington, D.C., and his associates.

“Accounts masquerading as legitimate users create false equivalency, eroding public consensus on vaccination,” creating an environment in which countering vaccine skepticism actually enable bots to “legitimize the vaccine debate,” the researchers concluded in the American Journal of Public Health (Am J Public Health. doi: 10.2105/AJPH.2018.304567).

“This is vital knowledge for risk communicators, especially considering that neither members of the public nor algorithmic approaches may be able to easily identify bots, trolls, or cyborgs.”

The researchers conducted two content analyses and one qualitative analysis of tweets from July 2014 to September 2017. Their data set included 1% of all tweets during that time period and a sample of tweets containing vaccine-related keywords.

First they compared rates of vaccine-related tweets between bots and average users, and then they assessed the attitude of these tweets from different account types. Their qualitative case study focused on the use of the hashtag #vaccinateUS which was predominantly used by Russian trolls.

The researchers relied on seven publicly available lists to identify which accounts were bots or trolls and then compared them to randomly selected tweets posted in the same time period.

In their second analysis, the researchers used Botometer, a program created by the Indiana University Network Science Institute (IUNI) and the Center for Complex Networks and Systems Research (CNetS), to categorize tweets as very likely to be human, very likely to be bots, or of uncertain provenance.

Results revealed that Russian trolls, sophisticated bot accounts, and “content polluters” – those that spread malware and unsolicited content – are more likely than average users to tweet about vaccination. Content polluters tweeted more anti-vaccine messages while Russian trolls and sophisticated bots promoted both anti-vaccine and pro-vaccine messages that amplified the polarization (P less than .001).

The higher rate of antivaccine messages from content polluters suggested that antivaccine advocates may have exploited existing bot networks for their messaging.

“These accounts may also use the compelling nature of antivaccine content as clickbait to drive up advertising revenue and expose users to malware,” Dr. Broniatowski and colleagues wrote. “Antivaccine content may increase the risks of infection by both computer and biological viruses.”

The qualitative analysis of the #VaccinateUS hashtag found that 43% were provaccine, 38% were antivaccine and the other 19% were neutral.

“Whereas most non-neutral vaccine-relevant hashtags were clearly identifiable as either provaccine (#vaccineswork, #vaxwithme) or antivaccine (#Vaxxed, #b1less, #CDCWhistleblower), with limited appropriation by the opposing side, #VaccinateUS is unique in that it appears with very polarized messages on both sides,” the researchers reported.

Tweets using the #VaccinateUS hashtags were also more likely to contain grammatical errors, unnatural word choices, and irregular phrasing – but fewer spelling or punctuation errors than average tweets related to vaccines.

“The #VaccinateUS messages are also distinctive in that they contain no links to outside content, rare @mentions of other users, and no images (but occasionally use some emojis),” the researchers found.

Although messages with that hashtag “mirrored” Twitter’s overall vaccine discourse, subtle differences included greater emphasis on “freedom,” “democracy,” and “constitutional rights” than the more common “parental choice” focus of tweets using other vaccine-related hashtags. The conspiracy-theory targets of #VaccinateUS tweets also focused almost entirely on the U.S. government instead of a wide range of conspiracy theories at large, which was more common in other anti-vaccine tweets.

Antivaccine content was densest among accounts, with accounts falling in the middle bot category of uncertainty.

“Although we speculate that this set of accounts contains more sophisticated bots, trolls, and cyborgs, their provenance is ultimately unknown,” the researchers wrote. “Therefore, beyond attempting to prevent bots from spreading messages over social media, public health practitioners should focus on combating the messages themselves while not feeding the trolls.”

The research was funded by the National Institutes of Health. No conflicts of interest were noted.

SOURCE: Broniatowski DA  et al. Am J Public Health. 2018 Aug 23. doi: 10.2105/AJPH.2018.304567.

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Russian trolls and bots significantly intensified the polarization of vaccine messaging on Twitter, fostering discord on the social network, according to researchers who analyzed the content of tweets over a 3-year period.

copyright DesignPics/Thinkstock

“Bots and trolls are actively involved in the online public health discourse, skewing discussions about vaccination,” wrote David A. Broniatowski, PhD, of George Washington University, Washington, D.C., and his associates.

“Accounts masquerading as legitimate users create false equivalency, eroding public consensus on vaccination,” creating an environment in which countering vaccine skepticism actually enable bots to “legitimize the vaccine debate,” the researchers concluded in the American Journal of Public Health (Am J Public Health. doi: 10.2105/AJPH.2018.304567).

“This is vital knowledge for risk communicators, especially considering that neither members of the public nor algorithmic approaches may be able to easily identify bots, trolls, or cyborgs.”

The researchers conducted two content analyses and one qualitative analysis of tweets from July 2014 to September 2017. Their data set included 1% of all tweets during that time period and a sample of tweets containing vaccine-related keywords.

First they compared rates of vaccine-related tweets between bots and average users, and then they assessed the attitude of these tweets from different account types. Their qualitative case study focused on the use of the hashtag #vaccinateUS which was predominantly used by Russian trolls.

The researchers relied on seven publicly available lists to identify which accounts were bots or trolls and then compared them to randomly selected tweets posted in the same time period.

In their second analysis, the researchers used Botometer, a program created by the Indiana University Network Science Institute (IUNI) and the Center for Complex Networks and Systems Research (CNetS), to categorize tweets as very likely to be human, very likely to be bots, or of uncertain provenance.

Results revealed that Russian trolls, sophisticated bot accounts, and “content polluters” – those that spread malware and unsolicited content – are more likely than average users to tweet about vaccination. Content polluters tweeted more anti-vaccine messages while Russian trolls and sophisticated bots promoted both anti-vaccine and pro-vaccine messages that amplified the polarization (P less than .001).

The higher rate of antivaccine messages from content polluters suggested that antivaccine advocates may have exploited existing bot networks for their messaging.

“These accounts may also use the compelling nature of antivaccine content as clickbait to drive up advertising revenue and expose users to malware,” Dr. Broniatowski and colleagues wrote. “Antivaccine content may increase the risks of infection by both computer and biological viruses.”

The qualitative analysis of the #VaccinateUS hashtag found that 43% were provaccine, 38% were antivaccine and the other 19% were neutral.

“Whereas most non-neutral vaccine-relevant hashtags were clearly identifiable as either provaccine (#vaccineswork, #vaxwithme) or antivaccine (#Vaxxed, #b1less, #CDCWhistleblower), with limited appropriation by the opposing side, #VaccinateUS is unique in that it appears with very polarized messages on both sides,” the researchers reported.

Tweets using the #VaccinateUS hashtags were also more likely to contain grammatical errors, unnatural word choices, and irregular phrasing – but fewer spelling or punctuation errors than average tweets related to vaccines.

“The #VaccinateUS messages are also distinctive in that they contain no links to outside content, rare @mentions of other users, and no images (but occasionally use some emojis),” the researchers found.

Although messages with that hashtag “mirrored” Twitter’s overall vaccine discourse, subtle differences included greater emphasis on “freedom,” “democracy,” and “constitutional rights” than the more common “parental choice” focus of tweets using other vaccine-related hashtags. The conspiracy-theory targets of #VaccinateUS tweets also focused almost entirely on the U.S. government instead of a wide range of conspiracy theories at large, which was more common in other anti-vaccine tweets.

Antivaccine content was densest among accounts, with accounts falling in the middle bot category of uncertainty.

“Although we speculate that this set of accounts contains more sophisticated bots, trolls, and cyborgs, their provenance is ultimately unknown,” the researchers wrote. “Therefore, beyond attempting to prevent bots from spreading messages over social media, public health practitioners should focus on combating the messages themselves while not feeding the trolls.”

The research was funded by the National Institutes of Health. No conflicts of interest were noted.

SOURCE: Broniatowski DA  et al. Am J Public Health. 2018 Aug 23. doi: 10.2105/AJPH.2018.304567.

Russian trolls and bots significantly intensified the polarization of vaccine messaging on Twitter, fostering discord on the social network, according to researchers who analyzed the content of tweets over a 3-year period.

copyright DesignPics/Thinkstock

“Bots and trolls are actively involved in the online public health discourse, skewing discussions about vaccination,” wrote David A. Broniatowski, PhD, of George Washington University, Washington, D.C., and his associates.

“Accounts masquerading as legitimate users create false equivalency, eroding public consensus on vaccination,” creating an environment in which countering vaccine skepticism actually enable bots to “legitimize the vaccine debate,” the researchers concluded in the American Journal of Public Health (Am J Public Health. doi: 10.2105/AJPH.2018.304567).

“This is vital knowledge for risk communicators, especially considering that neither members of the public nor algorithmic approaches may be able to easily identify bots, trolls, or cyborgs.”

The researchers conducted two content analyses and one qualitative analysis of tweets from July 2014 to September 2017. Their data set included 1% of all tweets during that time period and a sample of tweets containing vaccine-related keywords.

First they compared rates of vaccine-related tweets between bots and average users, and then they assessed the attitude of these tweets from different account types. Their qualitative case study focused on the use of the hashtag #vaccinateUS which was predominantly used by Russian trolls.

The researchers relied on seven publicly available lists to identify which accounts were bots or trolls and then compared them to randomly selected tweets posted in the same time period.

In their second analysis, the researchers used Botometer, a program created by the Indiana University Network Science Institute (IUNI) and the Center for Complex Networks and Systems Research (CNetS), to categorize tweets as very likely to be human, very likely to be bots, or of uncertain provenance.

Results revealed that Russian trolls, sophisticated bot accounts, and “content polluters” – those that spread malware and unsolicited content – are more likely than average users to tweet about vaccination. Content polluters tweeted more anti-vaccine messages while Russian trolls and sophisticated bots promoted both anti-vaccine and pro-vaccine messages that amplified the polarization (P less than .001).

The higher rate of antivaccine messages from content polluters suggested that antivaccine advocates may have exploited existing bot networks for their messaging.

“These accounts may also use the compelling nature of antivaccine content as clickbait to drive up advertising revenue and expose users to malware,” Dr. Broniatowski and colleagues wrote. “Antivaccine content may increase the risks of infection by both computer and biological viruses.”

The qualitative analysis of the #VaccinateUS hashtag found that 43% were provaccine, 38% were antivaccine and the other 19% were neutral.

“Whereas most non-neutral vaccine-relevant hashtags were clearly identifiable as either provaccine (#vaccineswork, #vaxwithme) or antivaccine (#Vaxxed, #b1less, #CDCWhistleblower), with limited appropriation by the opposing side, #VaccinateUS is unique in that it appears with very polarized messages on both sides,” the researchers reported.

Tweets using the #VaccinateUS hashtags were also more likely to contain grammatical errors, unnatural word choices, and irregular phrasing – but fewer spelling or punctuation errors than average tweets related to vaccines.

“The #VaccinateUS messages are also distinctive in that they contain no links to outside content, rare @mentions of other users, and no images (but occasionally use some emojis),” the researchers found.

Although messages with that hashtag “mirrored” Twitter’s overall vaccine discourse, subtle differences included greater emphasis on “freedom,” “democracy,” and “constitutional rights” than the more common “parental choice” focus of tweets using other vaccine-related hashtags. The conspiracy-theory targets of #VaccinateUS tweets also focused almost entirely on the U.S. government instead of a wide range of conspiracy theories at large, which was more common in other anti-vaccine tweets.

Antivaccine content was densest among accounts, with accounts falling in the middle bot category of uncertainty.

“Although we speculate that this set of accounts contains more sophisticated bots, trolls, and cyborgs, their provenance is ultimately unknown,” the researchers wrote. “Therefore, beyond attempting to prevent bots from spreading messages over social media, public health practitioners should focus on combating the messages themselves while not feeding the trolls.”

The research was funded by the National Institutes of Health. No conflicts of interest were noted.

SOURCE: Broniatowski DA  et al. Am J Public Health. 2018 Aug 23. doi: 10.2105/AJPH.2018.304567.

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Key clinical point: Twitter bots and trolls are polluting social media vaccine discussions.

Major finding: Russian trolls and bots are more likely to amplify polarization of vaccine Twitter messaging while other trolls and bots are more likely to promote anti-vaccine messages and malware.

Study details: The findings are based on three content analyses of vaccine-related Twitter content samples from July 2014 to September 2017.

Disclosures: The research was funded by the National Institutes of Health. No conflicts of interest were noted.

Source: Broniatowski, D et al. Am J Public Health. doi:10.2105/AJPH.2018.304567.

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No increase in primary ovarian insufficiency with HPV vaccine

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The human papillomavirus vaccine does not appear to be associated with an increased risk of ovarian insufficiency, according to researchers.

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Allison L. Naleway, PhD, of the Center for Health Research at Kaiser Permanente Northwest, Portland, Ore., and her coauthors wrote that a previous case series had raised concerns about a possible link between the human papillomavirus (HPV) vaccine and primary ovarian insufficiency (POI) in six young women who developed the condition within 12 months of vaccination.

Using EHR data, researchers identified 46 women aged 11-34 years with idiopathic POI – 33 probable cases and 13 possible cases – after excluding cases with known causes. Eighteen of these cases also were excluded because they were diagnosed before the HPV vaccine was available.

They found that only 1 of the remaining 28 patients had been vaccinated against HPV before the symptom onset: a 16-year-old girl who was vaccinated about 23 months before the first clinical evaluation for delayed menarche. Their report was published in Pediatrics.

The adjusted hazard ratio for POI was therefore 0.30 after HPV vaccine, compared with 0.88 after Tdap, 1.42 after inactivated influenza vaccine, and 0.94 after meningococcal conjugate vaccine.

More than one-half of the 46 confirmed POI cases were diagnosed at age 27 years or older, and only one patient was diagnosed under 15 years of age.

“If POI is triggered by HPV or other adolescent vaccine exposure, we would have expected to see elevated incidence in the younger women who were most likely to be vaccinated, but instead we observed higher incidence in older women (greater than 26 years of age), which is consistent with 1 other population-based study of POI prevalence,” the authors wrote.

They acknowledged that studying POI as a vaccine-related adverse event was challenging because the time from symptom onset to diagnosis was variable. However, they said that 81% of their cohort was followed up for more than 2 years, and a mean of 5.14 years, so the potential for misclassification was “minimal.”

Dr. Naleway and her associates also noted that diagnoses of POI can be difficult to accurately identify, and symptoms may be masked by oral contraceptive use.

“Despite the challenges and limitations discussed above, we believe this study should lessen concern surrounding potential impact on fertility from HPV or other adolescent vaccination,” they wrote.

The Centers for Disease Control and Prevention supported the study. Three authors declared funding from pharmaceutical companies for unrelated studies. No other conflicts of interest were declared.

SOURCE: Naleway A et al. Pediatrics 2018;42(3):e20180943.

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The human papillomavirus vaccine does not appear to be associated with an increased risk of ovarian insufficiency, according to researchers.

Choreograph/Thinkstock

Allison L. Naleway, PhD, of the Center for Health Research at Kaiser Permanente Northwest, Portland, Ore., and her coauthors wrote that a previous case series had raised concerns about a possible link between the human papillomavirus (HPV) vaccine and primary ovarian insufficiency (POI) in six young women who developed the condition within 12 months of vaccination.

Using EHR data, researchers identified 46 women aged 11-34 years with idiopathic POI – 33 probable cases and 13 possible cases – after excluding cases with known causes. Eighteen of these cases also were excluded because they were diagnosed before the HPV vaccine was available.

They found that only 1 of the remaining 28 patients had been vaccinated against HPV before the symptom onset: a 16-year-old girl who was vaccinated about 23 months before the first clinical evaluation for delayed menarche. Their report was published in Pediatrics.

The adjusted hazard ratio for POI was therefore 0.30 after HPV vaccine, compared with 0.88 after Tdap, 1.42 after inactivated influenza vaccine, and 0.94 after meningococcal conjugate vaccine.

More than one-half of the 46 confirmed POI cases were diagnosed at age 27 years or older, and only one patient was diagnosed under 15 years of age.

“If POI is triggered by HPV or other adolescent vaccine exposure, we would have expected to see elevated incidence in the younger women who were most likely to be vaccinated, but instead we observed higher incidence in older women (greater than 26 years of age), which is consistent with 1 other population-based study of POI prevalence,” the authors wrote.

They acknowledged that studying POI as a vaccine-related adverse event was challenging because the time from symptom onset to diagnosis was variable. However, they said that 81% of their cohort was followed up for more than 2 years, and a mean of 5.14 years, so the potential for misclassification was “minimal.”

Dr. Naleway and her associates also noted that diagnoses of POI can be difficult to accurately identify, and symptoms may be masked by oral contraceptive use.

“Despite the challenges and limitations discussed above, we believe this study should lessen concern surrounding potential impact on fertility from HPV or other adolescent vaccination,” they wrote.

The Centers for Disease Control and Prevention supported the study. Three authors declared funding from pharmaceutical companies for unrelated studies. No other conflicts of interest were declared.

SOURCE: Naleway A et al. Pediatrics 2018;42(3):e20180943.

 

The human papillomavirus vaccine does not appear to be associated with an increased risk of ovarian insufficiency, according to researchers.

Choreograph/Thinkstock

Allison L. Naleway, PhD, of the Center for Health Research at Kaiser Permanente Northwest, Portland, Ore., and her coauthors wrote that a previous case series had raised concerns about a possible link between the human papillomavirus (HPV) vaccine and primary ovarian insufficiency (POI) in six young women who developed the condition within 12 months of vaccination.

Using EHR data, researchers identified 46 women aged 11-34 years with idiopathic POI – 33 probable cases and 13 possible cases – after excluding cases with known causes. Eighteen of these cases also were excluded because they were diagnosed before the HPV vaccine was available.

They found that only 1 of the remaining 28 patients had been vaccinated against HPV before the symptom onset: a 16-year-old girl who was vaccinated about 23 months before the first clinical evaluation for delayed menarche. Their report was published in Pediatrics.

The adjusted hazard ratio for POI was therefore 0.30 after HPV vaccine, compared with 0.88 after Tdap, 1.42 after inactivated influenza vaccine, and 0.94 after meningococcal conjugate vaccine.

More than one-half of the 46 confirmed POI cases were diagnosed at age 27 years or older, and only one patient was diagnosed under 15 years of age.

“If POI is triggered by HPV or other adolescent vaccine exposure, we would have expected to see elevated incidence in the younger women who were most likely to be vaccinated, but instead we observed higher incidence in older women (greater than 26 years of age), which is consistent with 1 other population-based study of POI prevalence,” the authors wrote.

They acknowledged that studying POI as a vaccine-related adverse event was challenging because the time from symptom onset to diagnosis was variable. However, they said that 81% of their cohort was followed up for more than 2 years, and a mean of 5.14 years, so the potential for misclassification was “minimal.”

Dr. Naleway and her associates also noted that diagnoses of POI can be difficult to accurately identify, and symptoms may be masked by oral contraceptive use.

“Despite the challenges and limitations discussed above, we believe this study should lessen concern surrounding potential impact on fertility from HPV or other adolescent vaccination,” they wrote.

The Centers for Disease Control and Prevention supported the study. Three authors declared funding from pharmaceutical companies for unrelated studies. No other conflicts of interest were declared.

SOURCE: Naleway A et al. Pediatrics 2018;42(3):e20180943.

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Key clinical point: The HPV vaccine is not associated with an increased risk of primary ovarian insufficiency.

Major finding: The adjusted hazard ratio for POI was 0.30 after HPV vaccine, compared with 0.88 after Tdap, 1.42 after inactivated influenza vaccine, and 0.94 after meningococcal conjugate vaccine.

Study details: Analysis of medical records data for 46 women with confirmed iatrogenic primary ovarian failure.

Disclosures: The study was supported by the Centers for Disease Control and Prevention. Three authors declared funding from pharmaceutical companies for unrelated studies. No other conflicts of interest were declared.

Source: Naleway A et al. Pediatrics 2018;142(3):e20180943.

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Many physicians don’t discuss MenB vaccine in teen well visits

Strength of recommendation may influence physician enthusiasm
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Only one-third to one-half of physicians treating teens are discussing serogroup B meningococcal (MenB) vaccines during routine adolescent visits, survey results showed.

Rawpixel/Thinkstock

About half of pediatricians and one-third of family physicians said they always or often initiate discussion of MenB vaccines for adolescents aged 16- 18 year, according to a report on the survey published in Pediatrics.

However, it is challenging to say whether or not that level of discussion is on track with ideal clinical practice, according to Allison Kempe, MD, MPH, of the University of Colorado at Denver and Children’s Hospital Colorado, Aurora, and her coauthors. While MenB vaccines are recommended in this setting, the new Category B designation used for the recommendation indicates that the vaccines “may be administered” in the context of individual clinical decision making.

While some interpret the new Category B recommendation to mean that a discussion should always occur, others may interpret the recommendation as applicable to their own assessment of risks and benefits, without the need to involve patients and parents.

“Providers not initiating a discussion may not think the time required to discuss the MenB vaccine is justified by the risks posed by the disease or the benefits offered by these vaccines,” wrote Dr. Kempe and her associates. “Alternatively, they may have a low level of awareness regarding the disease or the MenB vaccine and feel insufficiently knowledgeable to have an informed discussion about the pros and cons of vaccination. They also may have been entirely unaware of the ACIP [Advisory Committee on Immunization Practices] recommendation for MenB vaccination.”

Dr. Kempe and her colleagues invited a nationally representative sample of primary care physicians to complete the survey, which was administered via Internet or mail between October and December 2016. They heard back from 374 of 475 (79%) pediatricians and 286 of 441 (65%) family physicians.

A total of 50% of pediatricians and 31% of family physicians said they always or often discussed MenB vaccines during routine visits with adolescents aged 16-18 years, with slightly higher percentages saying they initiated discussions during precollege physical exams, according to the report. Of the pediatricians, 58% recommended the MenB vaccine to those in this age group, compared with 50% of family physicians. Not all physicians who recommended the vaccine reported consistently initiating a discussion about it.

Nearly three-fourths of pediatricians and 41% of family physicians reported currently administering the MenB vaccine in their practices, the authors said, adding that greater awareness of disease outbreaks was linked to higher likelihood of discussing the vaccine, while working in an HMO setting was linked to lower likelihood of initiating that discussion.

Recommending MenB vaccination was closely tied to discussing the vaccine. Physicians who said they initiated discussion almost always reported making a recommendation to vaccinate, and conversely, those who rarely initiated discussions were unlikely to recommend it, according to Dr. Kempe and her colleagues.

Factors that made physicians more likely to recommend vaccine included awareness of outbreaks, effectiveness and safety data, and duration of vaccine protection.

The Category B recommendation, on the other hand, was one of the key factors that made physicians less likely to recommend MenB vaccine, according to this survey. ACIP made the Category B recommendation in October 2015, stating that those aged 16- 23 years may be vaccinated, with a preferred age of 16-18 years for administration. The accompanying rationale for the Category B designation referenced the low disease prevalence and insufficient data on effectiveness and safety for the two vaccines, which were both licensed under an accelerated approval mechanism following the outbreaks that have occurred on college campuses.

The Centers for Disease Control and Prevention did not provide additional guidance on how that Category B recommendation should be implemented, Dr. Kempe and her coauthors noted in their report.

“With our data, we highlight the challenges providers face with implementing recommendations for vaccination based on individual clinical decision making when they have limited experience with a disease and limited knowledge of a new vaccine,” they wrote.

The research was funded by the CDC. Dr. Kempe and her coauthors reported no relevant financial relationships or potential conflicts of interest.

SOURCE: Kempe A et al. Pediatrics. 2018 Aug 20. doi: 10.1542/peds.2018-0344.

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These survey results suggest primary care physicians’ zeal for discussing meningococcal serogroup B (MenB) vaccines during adolescent well visits is affected by the recommendation that they “may be administered” in this setting, according to Michael T. Brady, MD.

“When pediatricians are fortunate to have 16- to 18-year-old patients come to a routine visit, there are many important issues to discuss, such as sexual activity, tobacco, alcohol and illicit drug use, contraception, and mental health,” Dr. Brady wrote in an editorial discussing the survey results.

The new Category B designation, used by the Advisory Committee on Immunization Practices to recommend MenB vaccines for adolescents and young adults not at increased risk for meningococcal B disease, puts the recommendation in the realm of individual clinical decision making, Dr. Brady noted. “Without specific and clear guidance as to how to quantify benefits, risks, and costs for their individual patients, it is easy to understand why providers would have disparate responses reflecting the challenge associated with a new vaccine and a new vaccine recommendation classification.”

Pediatricians can achieve “exceptional rates of immunization” when recommendations are “evidence based, clear, and unequivocal,” but by contrast, they will remain challenged by Category B or permissive recommendations when clear guidance on how to implement the recommendation is not provided, he concluded.

Dr. Brad is a pediatric infectious diseases specialist at Nationwide Children’s Hospital and the Ohio State University, Columbus. These comments are from his editorial in Pediatrics (2018 Aug 20. doi: 10.1542/peds.2018-1633) . Dr. Brady reported receiving royalties from Up-To-Date for a chapter on human herpesvirus 6, but received no external funding for this editorial. He reported no potential conflicts of interest.

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These survey results suggest primary care physicians’ zeal for discussing meningococcal serogroup B (MenB) vaccines during adolescent well visits is affected by the recommendation that they “may be administered” in this setting, according to Michael T. Brady, MD.

“When pediatricians are fortunate to have 16- to 18-year-old patients come to a routine visit, there are many important issues to discuss, such as sexual activity, tobacco, alcohol and illicit drug use, contraception, and mental health,” Dr. Brady wrote in an editorial discussing the survey results.

The new Category B designation, used by the Advisory Committee on Immunization Practices to recommend MenB vaccines for adolescents and young adults not at increased risk for meningococcal B disease, puts the recommendation in the realm of individual clinical decision making, Dr. Brady noted. “Without specific and clear guidance as to how to quantify benefits, risks, and costs for their individual patients, it is easy to understand why providers would have disparate responses reflecting the challenge associated with a new vaccine and a new vaccine recommendation classification.”

Pediatricians can achieve “exceptional rates of immunization” when recommendations are “evidence based, clear, and unequivocal,” but by contrast, they will remain challenged by Category B or permissive recommendations when clear guidance on how to implement the recommendation is not provided, he concluded.

Dr. Brad is a pediatric infectious diseases specialist at Nationwide Children’s Hospital and the Ohio State University, Columbus. These comments are from his editorial in Pediatrics (2018 Aug 20. doi: 10.1542/peds.2018-1633) . Dr. Brady reported receiving royalties from Up-To-Date for a chapter on human herpesvirus 6, but received no external funding for this editorial. He reported no potential conflicts of interest.

Body

 

These survey results suggest primary care physicians’ zeal for discussing meningococcal serogroup B (MenB) vaccines during adolescent well visits is affected by the recommendation that they “may be administered” in this setting, according to Michael T. Brady, MD.

“When pediatricians are fortunate to have 16- to 18-year-old patients come to a routine visit, there are many important issues to discuss, such as sexual activity, tobacco, alcohol and illicit drug use, contraception, and mental health,” Dr. Brady wrote in an editorial discussing the survey results.

The new Category B designation, used by the Advisory Committee on Immunization Practices to recommend MenB vaccines for adolescents and young adults not at increased risk for meningococcal B disease, puts the recommendation in the realm of individual clinical decision making, Dr. Brady noted. “Without specific and clear guidance as to how to quantify benefits, risks, and costs for their individual patients, it is easy to understand why providers would have disparate responses reflecting the challenge associated with a new vaccine and a new vaccine recommendation classification.”

Pediatricians can achieve “exceptional rates of immunization” when recommendations are “evidence based, clear, and unequivocal,” but by contrast, they will remain challenged by Category B or permissive recommendations when clear guidance on how to implement the recommendation is not provided, he concluded.

Dr. Brad is a pediatric infectious diseases specialist at Nationwide Children’s Hospital and the Ohio State University, Columbus. These comments are from his editorial in Pediatrics (2018 Aug 20. doi: 10.1542/peds.2018-1633) . Dr. Brady reported receiving royalties from Up-To-Date for a chapter on human herpesvirus 6, but received no external funding for this editorial. He reported no potential conflicts of interest.

Title
Strength of recommendation may influence physician enthusiasm
Strength of recommendation may influence physician enthusiasm

 

Only one-third to one-half of physicians treating teens are discussing serogroup B meningococcal (MenB) vaccines during routine adolescent visits, survey results showed.

Rawpixel/Thinkstock

About half of pediatricians and one-third of family physicians said they always or often initiate discussion of MenB vaccines for adolescents aged 16- 18 year, according to a report on the survey published in Pediatrics.

However, it is challenging to say whether or not that level of discussion is on track with ideal clinical practice, according to Allison Kempe, MD, MPH, of the University of Colorado at Denver and Children’s Hospital Colorado, Aurora, and her coauthors. While MenB vaccines are recommended in this setting, the new Category B designation used for the recommendation indicates that the vaccines “may be administered” in the context of individual clinical decision making.

While some interpret the new Category B recommendation to mean that a discussion should always occur, others may interpret the recommendation as applicable to their own assessment of risks and benefits, without the need to involve patients and parents.

“Providers not initiating a discussion may not think the time required to discuss the MenB vaccine is justified by the risks posed by the disease or the benefits offered by these vaccines,” wrote Dr. Kempe and her associates. “Alternatively, they may have a low level of awareness regarding the disease or the MenB vaccine and feel insufficiently knowledgeable to have an informed discussion about the pros and cons of vaccination. They also may have been entirely unaware of the ACIP [Advisory Committee on Immunization Practices] recommendation for MenB vaccination.”

Dr. Kempe and her colleagues invited a nationally representative sample of primary care physicians to complete the survey, which was administered via Internet or mail between October and December 2016. They heard back from 374 of 475 (79%) pediatricians and 286 of 441 (65%) family physicians.

A total of 50% of pediatricians and 31% of family physicians said they always or often discussed MenB vaccines during routine visits with adolescents aged 16-18 years, with slightly higher percentages saying they initiated discussions during precollege physical exams, according to the report. Of the pediatricians, 58% recommended the MenB vaccine to those in this age group, compared with 50% of family physicians. Not all physicians who recommended the vaccine reported consistently initiating a discussion about it.

Nearly three-fourths of pediatricians and 41% of family physicians reported currently administering the MenB vaccine in their practices, the authors said, adding that greater awareness of disease outbreaks was linked to higher likelihood of discussing the vaccine, while working in an HMO setting was linked to lower likelihood of initiating that discussion.

Recommending MenB vaccination was closely tied to discussing the vaccine. Physicians who said they initiated discussion almost always reported making a recommendation to vaccinate, and conversely, those who rarely initiated discussions were unlikely to recommend it, according to Dr. Kempe and her colleagues.

Factors that made physicians more likely to recommend vaccine included awareness of outbreaks, effectiveness and safety data, and duration of vaccine protection.

The Category B recommendation, on the other hand, was one of the key factors that made physicians less likely to recommend MenB vaccine, according to this survey. ACIP made the Category B recommendation in October 2015, stating that those aged 16- 23 years may be vaccinated, with a preferred age of 16-18 years for administration. The accompanying rationale for the Category B designation referenced the low disease prevalence and insufficient data on effectiveness and safety for the two vaccines, which were both licensed under an accelerated approval mechanism following the outbreaks that have occurred on college campuses.

The Centers for Disease Control and Prevention did not provide additional guidance on how that Category B recommendation should be implemented, Dr. Kempe and her coauthors noted in their report.

“With our data, we highlight the challenges providers face with implementing recommendations for vaccination based on individual clinical decision making when they have limited experience with a disease and limited knowledge of a new vaccine,” they wrote.

The research was funded by the CDC. Dr. Kempe and her coauthors reported no relevant financial relationships or potential conflicts of interest.

SOURCE: Kempe A et al. Pediatrics. 2018 Aug 20. doi: 10.1542/peds.2018-0344.

 

Only one-third to one-half of physicians treating teens are discussing serogroup B meningococcal (MenB) vaccines during routine adolescent visits, survey results showed.

Rawpixel/Thinkstock

About half of pediatricians and one-third of family physicians said they always or often initiate discussion of MenB vaccines for adolescents aged 16- 18 year, according to a report on the survey published in Pediatrics.

However, it is challenging to say whether or not that level of discussion is on track with ideal clinical practice, according to Allison Kempe, MD, MPH, of the University of Colorado at Denver and Children’s Hospital Colorado, Aurora, and her coauthors. While MenB vaccines are recommended in this setting, the new Category B designation used for the recommendation indicates that the vaccines “may be administered” in the context of individual clinical decision making.

While some interpret the new Category B recommendation to mean that a discussion should always occur, others may interpret the recommendation as applicable to their own assessment of risks and benefits, without the need to involve patients and parents.

“Providers not initiating a discussion may not think the time required to discuss the MenB vaccine is justified by the risks posed by the disease or the benefits offered by these vaccines,” wrote Dr. Kempe and her associates. “Alternatively, they may have a low level of awareness regarding the disease or the MenB vaccine and feel insufficiently knowledgeable to have an informed discussion about the pros and cons of vaccination. They also may have been entirely unaware of the ACIP [Advisory Committee on Immunization Practices] recommendation for MenB vaccination.”

Dr. Kempe and her colleagues invited a nationally representative sample of primary care physicians to complete the survey, which was administered via Internet or mail between October and December 2016. They heard back from 374 of 475 (79%) pediatricians and 286 of 441 (65%) family physicians.

A total of 50% of pediatricians and 31% of family physicians said they always or often discussed MenB vaccines during routine visits with adolescents aged 16-18 years, with slightly higher percentages saying they initiated discussions during precollege physical exams, according to the report. Of the pediatricians, 58% recommended the MenB vaccine to those in this age group, compared with 50% of family physicians. Not all physicians who recommended the vaccine reported consistently initiating a discussion about it.

Nearly three-fourths of pediatricians and 41% of family physicians reported currently administering the MenB vaccine in their practices, the authors said, adding that greater awareness of disease outbreaks was linked to higher likelihood of discussing the vaccine, while working in an HMO setting was linked to lower likelihood of initiating that discussion.

Recommending MenB vaccination was closely tied to discussing the vaccine. Physicians who said they initiated discussion almost always reported making a recommendation to vaccinate, and conversely, those who rarely initiated discussions were unlikely to recommend it, according to Dr. Kempe and her colleagues.

Factors that made physicians more likely to recommend vaccine included awareness of outbreaks, effectiveness and safety data, and duration of vaccine protection.

The Category B recommendation, on the other hand, was one of the key factors that made physicians less likely to recommend MenB vaccine, according to this survey. ACIP made the Category B recommendation in October 2015, stating that those aged 16- 23 years may be vaccinated, with a preferred age of 16-18 years for administration. The accompanying rationale for the Category B designation referenced the low disease prevalence and insufficient data on effectiveness and safety for the two vaccines, which were both licensed under an accelerated approval mechanism following the outbreaks that have occurred on college campuses.

The Centers for Disease Control and Prevention did not provide additional guidance on how that Category B recommendation should be implemented, Dr. Kempe and her coauthors noted in their report.

“With our data, we highlight the challenges providers face with implementing recommendations for vaccination based on individual clinical decision making when they have limited experience with a disease and limited knowledge of a new vaccine,” they wrote.

The research was funded by the CDC. Dr. Kempe and her coauthors reported no relevant financial relationships or potential conflicts of interest.

SOURCE: Kempe A et al. Pediatrics. 2018 Aug 20. doi: 10.1542/peds.2018-0344.

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Key clinical point: Many primary care physicians are not discussing serogroup B meningococcal (MenB) vaccines during routine adolescent visits, possibly because of uncertainty about how current recommendations should be implemented.

Major finding: Half of pediatricians and 31% of family physicians said they always or often discussed MenB during routine visits with those aged 16- 18 years. Of the pediatricians, 58% recommended the MenB vaccine to adolescents in this age group, compared with 50% of family physicians.

Study details: A late 2016 survey of a nationally representative sample of 374 pediatricians and 286 family physicians.

Disclosures: The research was funded by the Centers for Disease Control and Prevention. Dr. Kempe and her coauthors reported no relevant financial relationships or potential conflicts of interest.

Source: Kempe A et al. Pediatrics. 2018 Aug 20. doi: 10.1542/peds.2018-0344.

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Zika virus vaccine trial launches

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A first-in-human trial of a live, attenuated Zika virus vaccine has begun, according to an announcement by the National Institutes of Health.

Courtesy National Institute of Allergy and Infectious Diseases
Zika virus particles (red) shown in African green monkey kidney cells.


The vaccine, developed by scientists at the National Institute of Allergy and Infectious Diseases will be tested in 28 healthy, nonpregnant adults aged 18-50 years at two centers, the Johns Hopkins Bloomberg School of Public Health Center for Immunization Research in Baltimore, and the Vaccine Testing Center at the University of Vermont in Burlington.

The challenge virus in the vaccine is an attenuated genetic chimera consisting of a dengue virus 4 backbone that expresses Zika virus surface proteins designed to elicit an immune response. The virus was previously tested in rhesus macaque monkeys.

Study participants for the phase 1 trial, Evaluation of the Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-Naive Adults, (NCT03611946) will be assessed based on local and general adverse events to the vaccine and peak neutralizing antibody titer to Zika virus as measured up to 90 days after vaccination. The trial is expected to be reach primary completion by Dec. 31, 2018.

If the phase 1 trial is successful, the goal is to integrate the vaccine with a live, attenuated dengue vaccine candidate called TV003, which is designed to elicit antibodies against all four dengue virus serotypes. The TV003 experimental vaccine is currently under evaluation in a phase 3 clinical trial (NCT02406729) underway in Brazil. Both Zika and dengue viruses frequently are endemic in the same regions and a single vaccine against both diseases would be valued. Stephen Whitehead, PhD of NIAID’s Laboratory of Viral Diseases led the efforts to develop both experimental vaccines.
 

SOURCE: NIH, August 16, 2018. News Release.

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A first-in-human trial of a live, attenuated Zika virus vaccine has begun, according to an announcement by the National Institutes of Health.

Courtesy National Institute of Allergy and Infectious Diseases
Zika virus particles (red) shown in African green monkey kidney cells.


The vaccine, developed by scientists at the National Institute of Allergy and Infectious Diseases will be tested in 28 healthy, nonpregnant adults aged 18-50 years at two centers, the Johns Hopkins Bloomberg School of Public Health Center for Immunization Research in Baltimore, and the Vaccine Testing Center at the University of Vermont in Burlington.

The challenge virus in the vaccine is an attenuated genetic chimera consisting of a dengue virus 4 backbone that expresses Zika virus surface proteins designed to elicit an immune response. The virus was previously tested in rhesus macaque monkeys.

Study participants for the phase 1 trial, Evaluation of the Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-Naive Adults, (NCT03611946) will be assessed based on local and general adverse events to the vaccine and peak neutralizing antibody titer to Zika virus as measured up to 90 days after vaccination. The trial is expected to be reach primary completion by Dec. 31, 2018.

If the phase 1 trial is successful, the goal is to integrate the vaccine with a live, attenuated dengue vaccine candidate called TV003, which is designed to elicit antibodies against all four dengue virus serotypes. The TV003 experimental vaccine is currently under evaluation in a phase 3 clinical trial (NCT02406729) underway in Brazil. Both Zika and dengue viruses frequently are endemic in the same regions and a single vaccine against both diseases would be valued. Stephen Whitehead, PhD of NIAID’s Laboratory of Viral Diseases led the efforts to develop both experimental vaccines.
 

SOURCE: NIH, August 16, 2018. News Release.

 

A first-in-human trial of a live, attenuated Zika virus vaccine has begun, according to an announcement by the National Institutes of Health.

Courtesy National Institute of Allergy and Infectious Diseases
Zika virus particles (red) shown in African green monkey kidney cells.


The vaccine, developed by scientists at the National Institute of Allergy and Infectious Diseases will be tested in 28 healthy, nonpregnant adults aged 18-50 years at two centers, the Johns Hopkins Bloomberg School of Public Health Center for Immunization Research in Baltimore, and the Vaccine Testing Center at the University of Vermont in Burlington.

The challenge virus in the vaccine is an attenuated genetic chimera consisting of a dengue virus 4 backbone that expresses Zika virus surface proteins designed to elicit an immune response. The virus was previously tested in rhesus macaque monkeys.

Study participants for the phase 1 trial, Evaluation of the Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-Naive Adults, (NCT03611946) will be assessed based on local and general adverse events to the vaccine and peak neutralizing antibody titer to Zika virus as measured up to 90 days after vaccination. The trial is expected to be reach primary completion by Dec. 31, 2018.

If the phase 1 trial is successful, the goal is to integrate the vaccine with a live, attenuated dengue vaccine candidate called TV003, which is designed to elicit antibodies against all four dengue virus serotypes. The TV003 experimental vaccine is currently under evaluation in a phase 3 clinical trial (NCT02406729) underway in Brazil. Both Zika and dengue viruses frequently are endemic in the same regions and a single vaccine against both diseases would be valued. Stephen Whitehead, PhD of NIAID’s Laboratory of Viral Diseases led the efforts to develop both experimental vaccines.
 

SOURCE: NIH, August 16, 2018. News Release.

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French warn of upsurge in pneumococcal meningitis

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– A French national study has documented a sharp increase in pneumococcal meningitis since 2015 in children under age 15 years.

Bruce Jancin/MDedge News
Dr. Naim Ouldali

The culprit has been identified as serotype 24F, which is not covered by the infant 13-valent conjugate pneumococcal vaccine (PCV13), Naim Ouldali, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.

The rapid emergence of serotype 24F has been accompanied by a disturbing change in its penicillin susceptibility. Indeed, penicillin resistance was present in only 18% of serotype 24F isolates in France during 2000-2014, then jumped to 74% during 2015-2016, according to Dr. Ouldali of René Descartes University in Paris.

“PCV13 has strongly reduced the pneumococcal meningitis burden in children, but its benefit now seems to be jeopardized, at least in France. So serum 24F could become a major concern in the coming years because of its characteristics. And now the question is, is this emergence an epidemic phenomenon or not? And if it’s confirmed in future studies and in other countries, probably it should drive the development of next-generation PCV formulations,” he said.

Dr. Ouldali presented a population-based interrupted time-series analysis of a nationwide prospective survey conducted in France during 2001-2016. He noted that the Cochrane Collaboration has deemed this study design second only to the randomized controlled trial in terms of quality of evidence.

The study, which included 227 French pediatric wards and 168 microbiology departments, identified 1,778 children under age 15 years with pneumococcal meningitis. This is believed to be more than 60% of all cases that occurred in the country during the study years.

The purpose of the study was to determine the impact of implementation of routine PCV13 as part of the national vaccine strategy. Rates of PCV13 coverage in French children are very high: in excess of 90% during 2015 to 2016.

Implementation of PCV13 led to a dramatic 38% reduction in the monthly incidence of pneumococcal meningitis, from 0.12 cases per 100,000 children before PCV13 to a low of 0.07 cases per 100,000 in December 2014. But after that the rate rebounded sharply, by 2.3% per month during 2015-2016, to a high of 0.13 cases per 100,000 per month by the end of 2016. Drilling down into the data, Dr. Ouldali and his coinvestigators learned that the resurgence of pneumococcal meningitis was due largely to the emergence of serotype 24F.

“This serotype is of particular concern because of two characteristics: First, it is already known to have a high disease potential – one of the highest, along with serotype 12F – and second, this rapid emergence was accompanied by a change in its penicillin susceptibility,” he noted.

Most of the French rebound in pneumococcal meningitis has occurred in children under 2 years of age. Of note, German investigators also have recently reported a rebound in invasive pneumococcal disease in German children under 16 years of age. Non-PCV13 serotypes accounted for 84% of all invasive pneumococcal disease during 2015-2016, with serotypes 10A and 24F leading the way. As in France, most of the resurgence has involved children less than 2 years old. However, unlike in France, most of the German increase has been in nonmeningitis forms of invasive pneumococcal disease (Vaccine. 2018 Jan 25;36[4]:572-7).

In response to a question from a concerned audience member, Dr. Ouldali said that while the penicillin susceptibility of serotype 24F has taken a sharp turn for the worse, cephalosporin susceptibility has not.

“To date, we have not seen any cephalosporin-resistant strains. To date, there is no need to use vancomycin,” he said.

Dr. Ouldali said the next step he and his colleagues plan to take is to see if there is a clonal expansion or a particular underlying genetic pattern which could explain the explosive emergence of 24F.

The study was funded by a research grant from Pfizer and by the French Pediatric Infectious Diseases Group.

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– A French national study has documented a sharp increase in pneumococcal meningitis since 2015 in children under age 15 years.

Bruce Jancin/MDedge News
Dr. Naim Ouldali

The culprit has been identified as serotype 24F, which is not covered by the infant 13-valent conjugate pneumococcal vaccine (PCV13), Naim Ouldali, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.

The rapid emergence of serotype 24F has been accompanied by a disturbing change in its penicillin susceptibility. Indeed, penicillin resistance was present in only 18% of serotype 24F isolates in France during 2000-2014, then jumped to 74% during 2015-2016, according to Dr. Ouldali of René Descartes University in Paris.

“PCV13 has strongly reduced the pneumococcal meningitis burden in children, but its benefit now seems to be jeopardized, at least in France. So serum 24F could become a major concern in the coming years because of its characteristics. And now the question is, is this emergence an epidemic phenomenon or not? And if it’s confirmed in future studies and in other countries, probably it should drive the development of next-generation PCV formulations,” he said.

Dr. Ouldali presented a population-based interrupted time-series analysis of a nationwide prospective survey conducted in France during 2001-2016. He noted that the Cochrane Collaboration has deemed this study design second only to the randomized controlled trial in terms of quality of evidence.

The study, which included 227 French pediatric wards and 168 microbiology departments, identified 1,778 children under age 15 years with pneumococcal meningitis. This is believed to be more than 60% of all cases that occurred in the country during the study years.

The purpose of the study was to determine the impact of implementation of routine PCV13 as part of the national vaccine strategy. Rates of PCV13 coverage in French children are very high: in excess of 90% during 2015 to 2016.

Implementation of PCV13 led to a dramatic 38% reduction in the monthly incidence of pneumococcal meningitis, from 0.12 cases per 100,000 children before PCV13 to a low of 0.07 cases per 100,000 in December 2014. But after that the rate rebounded sharply, by 2.3% per month during 2015-2016, to a high of 0.13 cases per 100,000 per month by the end of 2016. Drilling down into the data, Dr. Ouldali and his coinvestigators learned that the resurgence of pneumococcal meningitis was due largely to the emergence of serotype 24F.

“This serotype is of particular concern because of two characteristics: First, it is already known to have a high disease potential – one of the highest, along with serotype 12F – and second, this rapid emergence was accompanied by a change in its penicillin susceptibility,” he noted.

Most of the French rebound in pneumococcal meningitis has occurred in children under 2 years of age. Of note, German investigators also have recently reported a rebound in invasive pneumococcal disease in German children under 16 years of age. Non-PCV13 serotypes accounted for 84% of all invasive pneumococcal disease during 2015-2016, with serotypes 10A and 24F leading the way. As in France, most of the resurgence has involved children less than 2 years old. However, unlike in France, most of the German increase has been in nonmeningitis forms of invasive pneumococcal disease (Vaccine. 2018 Jan 25;36[4]:572-7).

In response to a question from a concerned audience member, Dr. Ouldali said that while the penicillin susceptibility of serotype 24F has taken a sharp turn for the worse, cephalosporin susceptibility has not.

“To date, we have not seen any cephalosporin-resistant strains. To date, there is no need to use vancomycin,” he said.

Dr. Ouldali said the next step he and his colleagues plan to take is to see if there is a clonal expansion or a particular underlying genetic pattern which could explain the explosive emergence of 24F.

The study was funded by a research grant from Pfizer and by the French Pediatric Infectious Diseases Group.

 

– A French national study has documented a sharp increase in pneumococcal meningitis since 2015 in children under age 15 years.

Bruce Jancin/MDedge News
Dr. Naim Ouldali

The culprit has been identified as serotype 24F, which is not covered by the infant 13-valent conjugate pneumococcal vaccine (PCV13), Naim Ouldali, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.

The rapid emergence of serotype 24F has been accompanied by a disturbing change in its penicillin susceptibility. Indeed, penicillin resistance was present in only 18% of serotype 24F isolates in France during 2000-2014, then jumped to 74% during 2015-2016, according to Dr. Ouldali of René Descartes University in Paris.

“PCV13 has strongly reduced the pneumococcal meningitis burden in children, but its benefit now seems to be jeopardized, at least in France. So serum 24F could become a major concern in the coming years because of its characteristics. And now the question is, is this emergence an epidemic phenomenon or not? And if it’s confirmed in future studies and in other countries, probably it should drive the development of next-generation PCV formulations,” he said.

Dr. Ouldali presented a population-based interrupted time-series analysis of a nationwide prospective survey conducted in France during 2001-2016. He noted that the Cochrane Collaboration has deemed this study design second only to the randomized controlled trial in terms of quality of evidence.

The study, which included 227 French pediatric wards and 168 microbiology departments, identified 1,778 children under age 15 years with pneumococcal meningitis. This is believed to be more than 60% of all cases that occurred in the country during the study years.

The purpose of the study was to determine the impact of implementation of routine PCV13 as part of the national vaccine strategy. Rates of PCV13 coverage in French children are very high: in excess of 90% during 2015 to 2016.

Implementation of PCV13 led to a dramatic 38% reduction in the monthly incidence of pneumococcal meningitis, from 0.12 cases per 100,000 children before PCV13 to a low of 0.07 cases per 100,000 in December 2014. But after that the rate rebounded sharply, by 2.3% per month during 2015-2016, to a high of 0.13 cases per 100,000 per month by the end of 2016. Drilling down into the data, Dr. Ouldali and his coinvestigators learned that the resurgence of pneumococcal meningitis was due largely to the emergence of serotype 24F.

“This serotype is of particular concern because of two characteristics: First, it is already known to have a high disease potential – one of the highest, along with serotype 12F – and second, this rapid emergence was accompanied by a change in its penicillin susceptibility,” he noted.

Most of the French rebound in pneumococcal meningitis has occurred in children under 2 years of age. Of note, German investigators also have recently reported a rebound in invasive pneumococcal disease in German children under 16 years of age. Non-PCV13 serotypes accounted for 84% of all invasive pneumococcal disease during 2015-2016, with serotypes 10A and 24F leading the way. As in France, most of the resurgence has involved children less than 2 years old. However, unlike in France, most of the German increase has been in nonmeningitis forms of invasive pneumococcal disease (Vaccine. 2018 Jan 25;36[4]:572-7).

In response to a question from a concerned audience member, Dr. Ouldali said that while the penicillin susceptibility of serotype 24F has taken a sharp turn for the worse, cephalosporin susceptibility has not.

“To date, we have not seen any cephalosporin-resistant strains. To date, there is no need to use vancomycin,” he said.

Dr. Ouldali said the next step he and his colleagues plan to take is to see if there is a clonal expansion or a particular underlying genetic pattern which could explain the explosive emergence of 24F.

The study was funded by a research grant from Pfizer and by the French Pediatric Infectious Diseases Group.

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Key clinical point: The recent rapid emergence of serotype 24F as a cause of pediatric pneumococcal meningitis in France could mark the beginning of a resurgent epidemic.

Major finding: The incidence of pneumococcal meningitis in French children jumped by 2.3% per month during 2015-2016.

Study details: This population-based interrupted time-series analysis included all 1,778 cases of pneumococcal meningitis in children under age 15 years during 2001-2016 in 227 French pediatric wards.

Disclosures: The study was funded by a grant from Pfizer and by the French Pediatric Infectious Diseases Group.

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No increase in autism risk with prenatal Tdap

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A retrospective cohort study in more than 80,000 children has found no evidence of an increased risk of autism spectrum disorder associated with prenatal tetanus, diphtheria, and acellular pertussis (Tdap) immunization.

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Of 81,993 children born between 2011 and 2014, 1,341 children (1.6%) were diagnosed with autism spectrum disorder. The incidence of autism spectrum disorder was 3.78 per 1,000 person-years in the Tdap-vaccinated group, and 4.05 per 1,000 person years in the unvaccinated group, representing an unadjusted hazard ratio of 0.98 and an adjusted hazard ratio of 0.85. This was consistent across all the birth cohorts.

Prenatal immunization rates with the prenatal Tdap vaccine ranged from 26% of the 2012 birth cohort to 79% of the 2014 birth cohort, and mean gestational age at vaccination was 28 weeks.

Tracy A. Becerra-Culqui, PhD, MPH, and colleagues of the department of research and evaluation at Kaiser Permanente Southern California, Pasadena, said this was the first study to look at the risk of autism spectrum disorder after maternal exposure to the Tdap vaccine, to their knowledge. “Our results potentially indicate that the maternal Tdap vaccine affects immune trajectories protecting infants against infections that would otherwise lead to neurodevelopmental alterations.”

They highlighted several strengths of their study. One was that maternal Tdap vaccination and information on autism spectrum disorder both were derived from EHRs and therefore not subject to recall bias. The study, published online in Pediatrics, also included children diagnosed with autism spectrum disorder from age 1 year onwards, reflecting the latest evidence on screening and diagnosis of autism.

“Our weighting procedures enabled us to balance the Tdap-exposed and -unexposed groups to compare two populations that were comparable in important measured confounding factors,” Dr. Becerra-Culqui and associates noted.

The investigators found that women who received the Tdap vaccine during pregnancy were more likely to be Asian American or Pacific Islander, to have a bachelor’s degree or higher, be nulliparous, to have also been vaccinated prenatally against influenza, and to deliver at term, compared with unvaccinated women.

However the authors did note that their follow-up was limited to 6.5 years for the earliest birth cohort, and 3.5 years for the latest cohort, so they may not have picked up children who received a later diagnosis of autism spectrum disorder.

The study was supported by Kaiser Permanente Southern California. Five authors declared funding from GlaxoSmithKline, Bayer AG, or the Centers for Disease Control and Prevention for unrelated or separate studies.

SOURCE: Becerra-Culqui T et al. Pediatrics. 2018;142(3):e20180120.

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A retrospective cohort study in more than 80,000 children has found no evidence of an increased risk of autism spectrum disorder associated with prenatal tetanus, diphtheria, and acellular pertussis (Tdap) immunization.

Piotr Marcinski/Thinkstock

Of 81,993 children born between 2011 and 2014, 1,341 children (1.6%) were diagnosed with autism spectrum disorder. The incidence of autism spectrum disorder was 3.78 per 1,000 person-years in the Tdap-vaccinated group, and 4.05 per 1,000 person years in the unvaccinated group, representing an unadjusted hazard ratio of 0.98 and an adjusted hazard ratio of 0.85. This was consistent across all the birth cohorts.

Prenatal immunization rates with the prenatal Tdap vaccine ranged from 26% of the 2012 birth cohort to 79% of the 2014 birth cohort, and mean gestational age at vaccination was 28 weeks.

Tracy A. Becerra-Culqui, PhD, MPH, and colleagues of the department of research and evaluation at Kaiser Permanente Southern California, Pasadena, said this was the first study to look at the risk of autism spectrum disorder after maternal exposure to the Tdap vaccine, to their knowledge. “Our results potentially indicate that the maternal Tdap vaccine affects immune trajectories protecting infants against infections that would otherwise lead to neurodevelopmental alterations.”

They highlighted several strengths of their study. One was that maternal Tdap vaccination and information on autism spectrum disorder both were derived from EHRs and therefore not subject to recall bias. The study, published online in Pediatrics, also included children diagnosed with autism spectrum disorder from age 1 year onwards, reflecting the latest evidence on screening and diagnosis of autism.

“Our weighting procedures enabled us to balance the Tdap-exposed and -unexposed groups to compare two populations that were comparable in important measured confounding factors,” Dr. Becerra-Culqui and associates noted.

The investigators found that women who received the Tdap vaccine during pregnancy were more likely to be Asian American or Pacific Islander, to have a bachelor’s degree or higher, be nulliparous, to have also been vaccinated prenatally against influenza, and to deliver at term, compared with unvaccinated women.

However the authors did note that their follow-up was limited to 6.5 years for the earliest birth cohort, and 3.5 years for the latest cohort, so they may not have picked up children who received a later diagnosis of autism spectrum disorder.

The study was supported by Kaiser Permanente Southern California. Five authors declared funding from GlaxoSmithKline, Bayer AG, or the Centers for Disease Control and Prevention for unrelated or separate studies.

SOURCE: Becerra-Culqui T et al. Pediatrics. 2018;142(3):e20180120.

 

A retrospective cohort study in more than 80,000 children has found no evidence of an increased risk of autism spectrum disorder associated with prenatal tetanus, diphtheria, and acellular pertussis (Tdap) immunization.

Piotr Marcinski/Thinkstock

Of 81,993 children born between 2011 and 2014, 1,341 children (1.6%) were diagnosed with autism spectrum disorder. The incidence of autism spectrum disorder was 3.78 per 1,000 person-years in the Tdap-vaccinated group, and 4.05 per 1,000 person years in the unvaccinated group, representing an unadjusted hazard ratio of 0.98 and an adjusted hazard ratio of 0.85. This was consistent across all the birth cohorts.

Prenatal immunization rates with the prenatal Tdap vaccine ranged from 26% of the 2012 birth cohort to 79% of the 2014 birth cohort, and mean gestational age at vaccination was 28 weeks.

Tracy A. Becerra-Culqui, PhD, MPH, and colleagues of the department of research and evaluation at Kaiser Permanente Southern California, Pasadena, said this was the first study to look at the risk of autism spectrum disorder after maternal exposure to the Tdap vaccine, to their knowledge. “Our results potentially indicate that the maternal Tdap vaccine affects immune trajectories protecting infants against infections that would otherwise lead to neurodevelopmental alterations.”

They highlighted several strengths of their study. One was that maternal Tdap vaccination and information on autism spectrum disorder both were derived from EHRs and therefore not subject to recall bias. The study, published online in Pediatrics, also included children diagnosed with autism spectrum disorder from age 1 year onwards, reflecting the latest evidence on screening and diagnosis of autism.

“Our weighting procedures enabled us to balance the Tdap-exposed and -unexposed groups to compare two populations that were comparable in important measured confounding factors,” Dr. Becerra-Culqui and associates noted.

The investigators found that women who received the Tdap vaccine during pregnancy were more likely to be Asian American or Pacific Islander, to have a bachelor’s degree or higher, be nulliparous, to have also been vaccinated prenatally against influenza, and to deliver at term, compared with unvaccinated women.

However the authors did note that their follow-up was limited to 6.5 years for the earliest birth cohort, and 3.5 years for the latest cohort, so they may not have picked up children who received a later diagnosis of autism spectrum disorder.

The study was supported by Kaiser Permanente Southern California. Five authors declared funding from GlaxoSmithKline, Bayer AG, or the Centers for Disease Control and Prevention for unrelated or separate studies.

SOURCE: Becerra-Culqui T et al. Pediatrics. 2018;142(3):e20180120.

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Key clinical point: Prenatal Tdap vaccine is not associated with an increased risk of autism spectrum disorder.

Major finding: The adjusted hazard ratio for autism spectrum disorder in children exposed to the prenatal Tdap vaccine is 0.98, compared with unvaccinated children.

Study details: A retrospective cohort study in 81,993 children exposed to the prenatal Tdap vaccine.

Disclosures: The study was supported by Kaiser Permanente Southern California. Five authors declared funding from GlaxoSmithKline, Bayer AG, or the Centers for Disease Control and Prevention for unrelated or separate studies.

Source: Becerra-Culqui T et al. Pediatrics. 2018;142(3):e20180120.

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ACP roadmap to raise adult immunization rates

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A national practice transformation initiative aimed at increasing laggardly adult immunization rates and reducing health disparities has scored an impressive success in a pilot project carried out in seven rural southwestern Georgia counties.

Bruce Jancin/MDedge News
Dr. Frances E. Ferguson

“We saw increases of 52%-93% in our pneumococcal vaccination rates in our nine adult medicine clinics,” Frances E. Ferguson, MD, said at the annual meeting of the American College of Physicians.

The project, conducted through the ACP’s quality improvement program, known as Quality Connect, with funding from the Centers for Disease Control and Prevention, has as its ultimate goal making adult immunization standard practice across the country in general internal medicine and primary care. One of the initial pilot projects was conducted at Albany (Ga.) Area Primary Health Care, a federally qualified community health center with 28 service delivery sites in seven mainly rural southwestern Georgia counties. The majority of the center’s patients are at or below the poverty level. The lessons learned from this and other successful local projects will be disseminated nationally, according to Dr. Ferguson, a general internist at the health center.

The project utilizes the ACP Quality Connect “Plan, Do, Study, Act” approach to implementing constructive changes in medical practice, coupled with an abundance of resources readily available from the nonprofit Immunization Action Coalition, which has been funded by the CDC for more than 20 years.

The coalition’s website includes easily downloadable and custom-modifiable standing orders, plain-language information handouts on pneumococcal pneumonia and other vaccine-preventable illnesses and possible vaccine side effects for patients to read in the waiting room before their office visit, concise CDC-standardized talking points for providers to use in convincing patients to get vaccinated, as well as a detailed 10-point action plan for medical practice leadership to make it all happen.

“You don’t have to reinvent the wheel with this. You just go to their website,” Dr. Ferguson explained.

She cited her personal experience as representative of that of her fellow general internists who got on board with the project’s goal. As of April 2016, just before rollout of the pilot project, Dr. Ferguson’s pneumococcal vaccination rate stood at 22.5%. One month into the project, her vaccination rate had zoomed to 60%. When the formal pilot project ended in February 2017, her rate was 88.2%, an absolute 65.7% increase in 10 months. And since the pilot project’s conclusion, adult pneumococcal vaccination rates across Albany Area Primary Health Care have continued to climb.

“We have continued to improve because our champions are still in place, and our standing orders are, too,” she noted.

Standing orders are at the core of the project’s success, according to Dr. Ferguson. They provide nurses with the legal authority to determine if a patient is eligible for a vaccine and to go ahead and give it before seeing the physician.

“The most important thing for me is that nurses are an essential and invaluable asset to your practice, especially when you empower them to function fully within the scope of their practice. They can do amazing things. I just feel like the nurses are the winners here. We are winners because of our nurses,” she said.

It wasn’t easy at first, Dr. Ferguson recalled.

“We had pushback from nurses because they were afraid to do anything without the doctor directly telling them to do it. And we had physicians who didn’t want to have standing orders because they didn’t want anybody to do anything until they told them to. But we managed to get all that straightened out in the first month,” according to the internist.

Other keys to the program’s success included designating champions of the project at every clinic. Often this was the director of nursing, who was appointed to be in charge of the standing orders program. This “champions” concept is detailed in the ACP Quality Connect website. The champion – Dr. Ferguson was one – gets staff buy in on promoting the importance of immunizations, teaches strategies, and engages in community outreach.

“They lead the practice in the quality improvement project. We found that was very important, to have someone at each site who could keep the fire under the staff, keep the project going even when it’s very busy and everybody’s running around. There has to be someone there who’s encouraging people to remember to keep giving immunizations in spite of everything that’s going on that day,” she explained.

A central principle of successful quality improvement programs is accurate performance data gathering and dissemination. “Doctors are very competitive people,” Dr. Ferguson observed. “When I tell you you’re not doing as well as your colleagues and I can show you a graph that shows how far you are lagging behind, you get the fire under you and get moving.”

Audience members were agog at the community health center’s stratospheric vaccination rates. What about all the vaccine skeptics? they asked.

“I think for us it’s a matter of trust,” she replied. “We are a community health center and many of our patients and our providers have been with us for a long time. The nursing staff live in those communities, so the patients know them well. The CDC’s cards with talking points are a big help. I take the time to talk to patients and explain how the vaccine is going to build an army of immunologic protection. There are always going to be the diehards who say, ‘My cousin’s foot fell off when he got the pneumonia vaccine,’ though. You can’t get past those people. There’s just nothing you can say to them that will change their mind.”

She reported having no financial conflicts regarding her presentation or the adult immunization initiative.

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A national practice transformation initiative aimed at increasing laggardly adult immunization rates and reducing health disparities has scored an impressive success in a pilot project carried out in seven rural southwestern Georgia counties.

Bruce Jancin/MDedge News
Dr. Frances E. Ferguson

“We saw increases of 52%-93% in our pneumococcal vaccination rates in our nine adult medicine clinics,” Frances E. Ferguson, MD, said at the annual meeting of the American College of Physicians.

The project, conducted through the ACP’s quality improvement program, known as Quality Connect, with funding from the Centers for Disease Control and Prevention, has as its ultimate goal making adult immunization standard practice across the country in general internal medicine and primary care. One of the initial pilot projects was conducted at Albany (Ga.) Area Primary Health Care, a federally qualified community health center with 28 service delivery sites in seven mainly rural southwestern Georgia counties. The majority of the center’s patients are at or below the poverty level. The lessons learned from this and other successful local projects will be disseminated nationally, according to Dr. Ferguson, a general internist at the health center.

The project utilizes the ACP Quality Connect “Plan, Do, Study, Act” approach to implementing constructive changes in medical practice, coupled with an abundance of resources readily available from the nonprofit Immunization Action Coalition, which has been funded by the CDC for more than 20 years.

The coalition’s website includes easily downloadable and custom-modifiable standing orders, plain-language information handouts on pneumococcal pneumonia and other vaccine-preventable illnesses and possible vaccine side effects for patients to read in the waiting room before their office visit, concise CDC-standardized talking points for providers to use in convincing patients to get vaccinated, as well as a detailed 10-point action plan for medical practice leadership to make it all happen.

“You don’t have to reinvent the wheel with this. You just go to their website,” Dr. Ferguson explained.

She cited her personal experience as representative of that of her fellow general internists who got on board with the project’s goal. As of April 2016, just before rollout of the pilot project, Dr. Ferguson’s pneumococcal vaccination rate stood at 22.5%. One month into the project, her vaccination rate had zoomed to 60%. When the formal pilot project ended in February 2017, her rate was 88.2%, an absolute 65.7% increase in 10 months. And since the pilot project’s conclusion, adult pneumococcal vaccination rates across Albany Area Primary Health Care have continued to climb.

“We have continued to improve because our champions are still in place, and our standing orders are, too,” she noted.

Standing orders are at the core of the project’s success, according to Dr. Ferguson. They provide nurses with the legal authority to determine if a patient is eligible for a vaccine and to go ahead and give it before seeing the physician.

“The most important thing for me is that nurses are an essential and invaluable asset to your practice, especially when you empower them to function fully within the scope of their practice. They can do amazing things. I just feel like the nurses are the winners here. We are winners because of our nurses,” she said.

It wasn’t easy at first, Dr. Ferguson recalled.

“We had pushback from nurses because they were afraid to do anything without the doctor directly telling them to do it. And we had physicians who didn’t want to have standing orders because they didn’t want anybody to do anything until they told them to. But we managed to get all that straightened out in the first month,” according to the internist.

Other keys to the program’s success included designating champions of the project at every clinic. Often this was the director of nursing, who was appointed to be in charge of the standing orders program. This “champions” concept is detailed in the ACP Quality Connect website. The champion – Dr. Ferguson was one – gets staff buy in on promoting the importance of immunizations, teaches strategies, and engages in community outreach.

“They lead the practice in the quality improvement project. We found that was very important, to have someone at each site who could keep the fire under the staff, keep the project going even when it’s very busy and everybody’s running around. There has to be someone there who’s encouraging people to remember to keep giving immunizations in spite of everything that’s going on that day,” she explained.

A central principle of successful quality improvement programs is accurate performance data gathering and dissemination. “Doctors are very competitive people,” Dr. Ferguson observed. “When I tell you you’re not doing as well as your colleagues and I can show you a graph that shows how far you are lagging behind, you get the fire under you and get moving.”

Audience members were agog at the community health center’s stratospheric vaccination rates. What about all the vaccine skeptics? they asked.

“I think for us it’s a matter of trust,” she replied. “We are a community health center and many of our patients and our providers have been with us for a long time. The nursing staff live in those communities, so the patients know them well. The CDC’s cards with talking points are a big help. I take the time to talk to patients and explain how the vaccine is going to build an army of immunologic protection. There are always going to be the diehards who say, ‘My cousin’s foot fell off when he got the pneumonia vaccine,’ though. You can’t get past those people. There’s just nothing you can say to them that will change their mind.”

She reported having no financial conflicts regarding her presentation or the adult immunization initiative.

[email protected]
 

 

A national practice transformation initiative aimed at increasing laggardly adult immunization rates and reducing health disparities has scored an impressive success in a pilot project carried out in seven rural southwestern Georgia counties.

Bruce Jancin/MDedge News
Dr. Frances E. Ferguson

“We saw increases of 52%-93% in our pneumococcal vaccination rates in our nine adult medicine clinics,” Frances E. Ferguson, MD, said at the annual meeting of the American College of Physicians.

The project, conducted through the ACP’s quality improvement program, known as Quality Connect, with funding from the Centers for Disease Control and Prevention, has as its ultimate goal making adult immunization standard practice across the country in general internal medicine and primary care. One of the initial pilot projects was conducted at Albany (Ga.) Area Primary Health Care, a federally qualified community health center with 28 service delivery sites in seven mainly rural southwestern Georgia counties. The majority of the center’s patients are at or below the poverty level. The lessons learned from this and other successful local projects will be disseminated nationally, according to Dr. Ferguson, a general internist at the health center.

The project utilizes the ACP Quality Connect “Plan, Do, Study, Act” approach to implementing constructive changes in medical practice, coupled with an abundance of resources readily available from the nonprofit Immunization Action Coalition, which has been funded by the CDC for more than 20 years.

The coalition’s website includes easily downloadable and custom-modifiable standing orders, plain-language information handouts on pneumococcal pneumonia and other vaccine-preventable illnesses and possible vaccine side effects for patients to read in the waiting room before their office visit, concise CDC-standardized talking points for providers to use in convincing patients to get vaccinated, as well as a detailed 10-point action plan for medical practice leadership to make it all happen.

“You don’t have to reinvent the wheel with this. You just go to their website,” Dr. Ferguson explained.

She cited her personal experience as representative of that of her fellow general internists who got on board with the project’s goal. As of April 2016, just before rollout of the pilot project, Dr. Ferguson’s pneumococcal vaccination rate stood at 22.5%. One month into the project, her vaccination rate had zoomed to 60%. When the formal pilot project ended in February 2017, her rate was 88.2%, an absolute 65.7% increase in 10 months. And since the pilot project’s conclusion, adult pneumococcal vaccination rates across Albany Area Primary Health Care have continued to climb.

“We have continued to improve because our champions are still in place, and our standing orders are, too,” she noted.

Standing orders are at the core of the project’s success, according to Dr. Ferguson. They provide nurses with the legal authority to determine if a patient is eligible for a vaccine and to go ahead and give it before seeing the physician.

“The most important thing for me is that nurses are an essential and invaluable asset to your practice, especially when you empower them to function fully within the scope of their practice. They can do amazing things. I just feel like the nurses are the winners here. We are winners because of our nurses,” she said.

It wasn’t easy at first, Dr. Ferguson recalled.

“We had pushback from nurses because they were afraid to do anything without the doctor directly telling them to do it. And we had physicians who didn’t want to have standing orders because they didn’t want anybody to do anything until they told them to. But we managed to get all that straightened out in the first month,” according to the internist.

Other keys to the program’s success included designating champions of the project at every clinic. Often this was the director of nursing, who was appointed to be in charge of the standing orders program. This “champions” concept is detailed in the ACP Quality Connect website. The champion – Dr. Ferguson was one – gets staff buy in on promoting the importance of immunizations, teaches strategies, and engages in community outreach.

“They lead the practice in the quality improvement project. We found that was very important, to have someone at each site who could keep the fire under the staff, keep the project going even when it’s very busy and everybody’s running around. There has to be someone there who’s encouraging people to remember to keep giving immunizations in spite of everything that’s going on that day,” she explained.

A central principle of successful quality improvement programs is accurate performance data gathering and dissemination. “Doctors are very competitive people,” Dr. Ferguson observed. “When I tell you you’re not doing as well as your colleagues and I can show you a graph that shows how far you are lagging behind, you get the fire under you and get moving.”

Audience members were agog at the community health center’s stratospheric vaccination rates. What about all the vaccine skeptics? they asked.

“I think for us it’s a matter of trust,” she replied. “We are a community health center and many of our patients and our providers have been with us for a long time. The nursing staff live in those communities, so the patients know them well. The CDC’s cards with talking points are a big help. I take the time to talk to patients and explain how the vaccine is going to build an army of immunologic protection. There are always going to be the diehards who say, ‘My cousin’s foot fell off when he got the pneumonia vaccine,’ though. You can’t get past those people. There’s just nothing you can say to them that will change their mind.”

She reported having no financial conflicts regarding her presentation or the adult immunization initiative.

[email protected]
 

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Study supports meningococcal B vaccine in children with rare diseases

Keep eculizumab guidelines on antibiotic prophylaxis in mind
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A new study, the first of its kind, provided support for guidelines suggesting that the capsular meningococcal B vaccine be given to children with three rare conditions that boost infection risk.

©Micah Young/istockphoto.com
The 4CMenB vaccine’s strength appeared to be similar in healthy children and in those with asplenia and splenic dysfunction. It may be weaker in those with complement deficiency, but it was not clear whether that affected its effectiveness. The study authors recommended that children with this condition receive antibiotic prophylaxis in addition to the vaccine.

For children with terminal chain complement deficiencies or who are undergoing treatment with eculizumab, “it is important that these patients are identified, receive education about sepsis management plans, and are prescribed prophylactic antibiotics according to local guidelines, along with vaccination, to provide every chance for them to be protected against this deadly disease,” the researchers wrote in Pediatrics.

While some countries suggest that the vaccine be given to all healthy infants, U.S. guidelines advise that the vaccine be given to preteenagers, teenagers, and adults who are considered at special risk. These include those with terminal chain complement deficiencies, who are believed to be up to 10,000 times more likely than healthy children to develop invasive meningococcal disease, and those who take eculizumab (Soliris). The risk groups recommended for vaccinations also include those with asplenia and splenic dysfunction, although their excess risk, if any, is unknown.

The new study of the capsular group meningococcal B vaccine, led by Federico Martinón-Torres, PhD, of the Hospital Clinico Universitario de Santiago de Compostela, Spain, adds to previous research that confirmed the effectiveness of vaccinating complement-deficient patients with capsular group A, C, W, and Y meningococcal vaccines.

For the open-label, phase 3b study, researchers in Italy, Spain, Poland, and Russia gave two doses of the vaccine 2 months apart to 239 children aged 2-17 years with an average age of 10 years. Nearly all were white, and 45% were female.

A total of 40 children had complement deficiency, 112 had asplenia or splenic dysfunction, and 87 children in the control group also received the vaccine.

Following vaccination, the percentages of children with exogenous complement serum bactericidal activity titers greater than or equal to 1:5 to the four test strains were similar in the healthy children and those with asplenia/splenic dysfunction. “It is reasonable to expect that this vaccine will be as effective in children with asplenia or splenic deficiency as in children in the control category,” the researchers wrote.

However, these levels were lower in the complement-deficient children, particularly in those with terminal chain complement deficiency and those who took eculizumab.

The proportions of children with exogenous complement serum bactericidal activity titers greater than or equal to 1:5 against the four test strains were 87% (H44/76), 95% (5/99), 68% (NZ98/254), and 73% (M10713) in complement-deficient children, compared with 98%, 99%, 83%, and 99%, respectively, in the healthy controls.

“Ongoing surveillance for vaccine failures is required to determine the significance of the trend to reduced immune response in children with terminal chain complement deficiencies or undergoing treatment with eculizumab,” the researchers wrote.

 

 

Eculizumab’s manufacturer has noted the risk of serious meningococcal infections and warned physicians to “immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection,” according to the website.

The study was funded by Novartis Vaccines and Diagnostics (now GlaxoSmithKline Biologicals). Some of the study authors reported various disclosures, including financial relationships with Novartis and GlaxoSmithKline outside the submitted work. Dr. Kaplan reported no relevant financial disclosures.

SOURCE: Martinón-Torres F et al. Pediatrics. 2018 Aug 1. doi: 10.1542/peds.2017-4250.

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The Centers for Disease Control and Prevention reported an annual average of 792 cases of meningococcal disease and 98 deaths in the United States from 2006 to 2015 with serotype B isolates causing the highest numbers of cases. In a recent development, two vaccines against this strain have become available in the United States in the past 3 years for people aged 10-25 years. But officials don’t recommend their routine use, instead, guidelines suggest they be given to those at high risk only.

There’s a gap in knowledge because vaccine researchers didn’t include people with complement deficiency (either congenital or related to eculizumab), asplenia, or splenic dysfunction in studies that led to approval. Now, the new study offers reassuring findings regarding the latter two conditions, as bactericidal antibody responses were equal to those in healthy controls.

The findings regarding complement deficiency aren’t surprising, and suggest that vaccine strength in children with the condition only reached the levels in healthy children when an exogenous complement was added.

The study supports guidelines suggesting antibiotic prophylaxis in patients receiving eculizumab even if they already underwent meningococcal vaccination. It’s not clear if this approach also will be effective in those with congenital complement deficiencies (except for complement component 6 deficiency).

It is hoped that surveillance studies will show that use of serogroup B vaccines will prevent invasive meningococcal infections in these high-risk populations for which they are recommended.

Sheldon L. Kaplan, MD, is a pediatrician at Baylor College of Medicine and Texas Children’s Hospital, both in Houston. These comments are summarized from an editorial accompanying the article by Martinón-Torres et al. (Pediatrics. 2018 Aug 1. doi: 10.1542/peds.2018-0554).

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The Centers for Disease Control and Prevention reported an annual average of 792 cases of meningococcal disease and 98 deaths in the United States from 2006 to 2015 with serotype B isolates causing the highest numbers of cases. In a recent development, two vaccines against this strain have become available in the United States in the past 3 years for people aged 10-25 years. But officials don’t recommend their routine use, instead, guidelines suggest they be given to those at high risk only.

There’s a gap in knowledge because vaccine researchers didn’t include people with complement deficiency (either congenital or related to eculizumab), asplenia, or splenic dysfunction in studies that led to approval. Now, the new study offers reassuring findings regarding the latter two conditions, as bactericidal antibody responses were equal to those in healthy controls.

The findings regarding complement deficiency aren’t surprising, and suggest that vaccine strength in children with the condition only reached the levels in healthy children when an exogenous complement was added.

The study supports guidelines suggesting antibiotic prophylaxis in patients receiving eculizumab even if they already underwent meningococcal vaccination. It’s not clear if this approach also will be effective in those with congenital complement deficiencies (except for complement component 6 deficiency).

It is hoped that surveillance studies will show that use of serogroup B vaccines will prevent invasive meningococcal infections in these high-risk populations for which they are recommended.

Sheldon L. Kaplan, MD, is a pediatrician at Baylor College of Medicine and Texas Children’s Hospital, both in Houston. These comments are summarized from an editorial accompanying the article by Martinón-Torres et al. (Pediatrics. 2018 Aug 1. doi: 10.1542/peds.2018-0554).

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The Centers for Disease Control and Prevention reported an annual average of 792 cases of meningococcal disease and 98 deaths in the United States from 2006 to 2015 with serotype B isolates causing the highest numbers of cases. In a recent development, two vaccines against this strain have become available in the United States in the past 3 years for people aged 10-25 years. But officials don’t recommend their routine use, instead, guidelines suggest they be given to those at high risk only.

There’s a gap in knowledge because vaccine researchers didn’t include people with complement deficiency (either congenital or related to eculizumab), asplenia, or splenic dysfunction in studies that led to approval. Now, the new study offers reassuring findings regarding the latter two conditions, as bactericidal antibody responses were equal to those in healthy controls.

The findings regarding complement deficiency aren’t surprising, and suggest that vaccine strength in children with the condition only reached the levels in healthy children when an exogenous complement was added.

The study supports guidelines suggesting antibiotic prophylaxis in patients receiving eculizumab even if they already underwent meningococcal vaccination. It’s not clear if this approach also will be effective in those with congenital complement deficiencies (except for complement component 6 deficiency).

It is hoped that surveillance studies will show that use of serogroup B vaccines will prevent invasive meningococcal infections in these high-risk populations for which they are recommended.

Sheldon L. Kaplan, MD, is a pediatrician at Baylor College of Medicine and Texas Children’s Hospital, both in Houston. These comments are summarized from an editorial accompanying the article by Martinón-Torres et al. (Pediatrics. 2018 Aug 1. doi: 10.1542/peds.2018-0554).

Title
Keep eculizumab guidelines on antibiotic prophylaxis in mind
Keep eculizumab guidelines on antibiotic prophylaxis in mind

 

A new study, the first of its kind, provided support for guidelines suggesting that the capsular meningococcal B vaccine be given to children with three rare conditions that boost infection risk.

©Micah Young/istockphoto.com
The 4CMenB vaccine’s strength appeared to be similar in healthy children and in those with asplenia and splenic dysfunction. It may be weaker in those with complement deficiency, but it was not clear whether that affected its effectiveness. The study authors recommended that children with this condition receive antibiotic prophylaxis in addition to the vaccine.

For children with terminal chain complement deficiencies or who are undergoing treatment with eculizumab, “it is important that these patients are identified, receive education about sepsis management plans, and are prescribed prophylactic antibiotics according to local guidelines, along with vaccination, to provide every chance for them to be protected against this deadly disease,” the researchers wrote in Pediatrics.

While some countries suggest that the vaccine be given to all healthy infants, U.S. guidelines advise that the vaccine be given to preteenagers, teenagers, and adults who are considered at special risk. These include those with terminal chain complement deficiencies, who are believed to be up to 10,000 times more likely than healthy children to develop invasive meningococcal disease, and those who take eculizumab (Soliris). The risk groups recommended for vaccinations also include those with asplenia and splenic dysfunction, although their excess risk, if any, is unknown.

The new study of the capsular group meningococcal B vaccine, led by Federico Martinón-Torres, PhD, of the Hospital Clinico Universitario de Santiago de Compostela, Spain, adds to previous research that confirmed the effectiveness of vaccinating complement-deficient patients with capsular group A, C, W, and Y meningococcal vaccines.

For the open-label, phase 3b study, researchers in Italy, Spain, Poland, and Russia gave two doses of the vaccine 2 months apart to 239 children aged 2-17 years with an average age of 10 years. Nearly all were white, and 45% were female.

A total of 40 children had complement deficiency, 112 had asplenia or splenic dysfunction, and 87 children in the control group also received the vaccine.

Following vaccination, the percentages of children with exogenous complement serum bactericidal activity titers greater than or equal to 1:5 to the four test strains were similar in the healthy children and those with asplenia/splenic dysfunction. “It is reasonable to expect that this vaccine will be as effective in children with asplenia or splenic deficiency as in children in the control category,” the researchers wrote.

However, these levels were lower in the complement-deficient children, particularly in those with terminal chain complement deficiency and those who took eculizumab.

The proportions of children with exogenous complement serum bactericidal activity titers greater than or equal to 1:5 against the four test strains were 87% (H44/76), 95% (5/99), 68% (NZ98/254), and 73% (M10713) in complement-deficient children, compared with 98%, 99%, 83%, and 99%, respectively, in the healthy controls.

“Ongoing surveillance for vaccine failures is required to determine the significance of the trend to reduced immune response in children with terminal chain complement deficiencies or undergoing treatment with eculizumab,” the researchers wrote.

 

 

Eculizumab’s manufacturer has noted the risk of serious meningococcal infections and warned physicians to “immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection,” according to the website.

The study was funded by Novartis Vaccines and Diagnostics (now GlaxoSmithKline Biologicals). Some of the study authors reported various disclosures, including financial relationships with Novartis and GlaxoSmithKline outside the submitted work. Dr. Kaplan reported no relevant financial disclosures.

SOURCE: Martinón-Torres F et al. Pediatrics. 2018 Aug 1. doi: 10.1542/peds.2017-4250.

 

A new study, the first of its kind, provided support for guidelines suggesting that the capsular meningococcal B vaccine be given to children with three rare conditions that boost infection risk.

©Micah Young/istockphoto.com
The 4CMenB vaccine’s strength appeared to be similar in healthy children and in those with asplenia and splenic dysfunction. It may be weaker in those with complement deficiency, but it was not clear whether that affected its effectiveness. The study authors recommended that children with this condition receive antibiotic prophylaxis in addition to the vaccine.

For children with terminal chain complement deficiencies or who are undergoing treatment with eculizumab, “it is important that these patients are identified, receive education about sepsis management plans, and are prescribed prophylactic antibiotics according to local guidelines, along with vaccination, to provide every chance for them to be protected against this deadly disease,” the researchers wrote in Pediatrics.

While some countries suggest that the vaccine be given to all healthy infants, U.S. guidelines advise that the vaccine be given to preteenagers, teenagers, and adults who are considered at special risk. These include those with terminal chain complement deficiencies, who are believed to be up to 10,000 times more likely than healthy children to develop invasive meningococcal disease, and those who take eculizumab (Soliris). The risk groups recommended for vaccinations also include those with asplenia and splenic dysfunction, although their excess risk, if any, is unknown.

The new study of the capsular group meningococcal B vaccine, led by Federico Martinón-Torres, PhD, of the Hospital Clinico Universitario de Santiago de Compostela, Spain, adds to previous research that confirmed the effectiveness of vaccinating complement-deficient patients with capsular group A, C, W, and Y meningococcal vaccines.

For the open-label, phase 3b study, researchers in Italy, Spain, Poland, and Russia gave two doses of the vaccine 2 months apart to 239 children aged 2-17 years with an average age of 10 years. Nearly all were white, and 45% were female.

A total of 40 children had complement deficiency, 112 had asplenia or splenic dysfunction, and 87 children in the control group also received the vaccine.

Following vaccination, the percentages of children with exogenous complement serum bactericidal activity titers greater than or equal to 1:5 to the four test strains were similar in the healthy children and those with asplenia/splenic dysfunction. “It is reasonable to expect that this vaccine will be as effective in children with asplenia or splenic deficiency as in children in the control category,” the researchers wrote.

However, these levels were lower in the complement-deficient children, particularly in those with terminal chain complement deficiency and those who took eculizumab.

The proportions of children with exogenous complement serum bactericidal activity titers greater than or equal to 1:5 against the four test strains were 87% (H44/76), 95% (5/99), 68% (NZ98/254), and 73% (M10713) in complement-deficient children, compared with 98%, 99%, 83%, and 99%, respectively, in the healthy controls.

“Ongoing surveillance for vaccine failures is required to determine the significance of the trend to reduced immune response in children with terminal chain complement deficiencies or undergoing treatment with eculizumab,” the researchers wrote.

 

 

Eculizumab’s manufacturer has noted the risk of serious meningococcal infections and warned physicians to “immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection,” according to the website.

The study was funded by Novartis Vaccines and Diagnostics (now GlaxoSmithKline Biologicals). Some of the study authors reported various disclosures, including financial relationships with Novartis and GlaxoSmithKline outside the submitted work. Dr. Kaplan reported no relevant financial disclosures.

SOURCE: Martinón-Torres F et al. Pediatrics. 2018 Aug 1. doi: 10.1542/peds.2017-4250.

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Key clinical point: The meningococcal B vaccine retained its strength in kids with two rare immunosuppressive diseases, but may be weaker in a third group.

Major finding: The vaccine’s effectiveness was roughly the same in healthy controls and in those with asplenia and splenic dysfunction, but it dipped in those with complement deficiency.

Study details: An open-label, multicenter analysis of children aged 2-17 years who received two doses over 2 months.

Disclosures: The study was funded by Novartis Vaccines and Diagnostics (now GlaxoSmithKline Biologicals). Some of the study authors reported various disclosures, including financial relationships with Novartis and GlaxoSmithKline outside the submitted work. Dr. Kaplan reported no relevant financial disclosures.

Source: Martinón-Torres F et al. Pediatrics. 2018 Aug 1. doi: 10.1542/peds.2017-4250.

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Liang JL, Tiwari T, Moro P, et al. Prevention of pertussis, tetanus, and diphtheria with vaccines in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2018;67:1-44.

Centers for Disease Control and Prevention. Pertussis (whooping cough). Available at: https://www.cdc.gov/pertussis/index.html. Accessed July 6, 2018.

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Doug Campos-Outcalt, MD, MPA, is a member of the US Community Preventive Services Task Force, a clinical professor at the University of Arizona College of Medicine, and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

Dr. Campos-Outcalt was a liaison to the Advisory Committee on Immunization Practices (ACIP) representing the American Academy of Family Practitioners for 6 years. For another 4 years, he was a voting member of ACIP. During those 10 years, several of the recommendations he mentions in this audiocast were discussed and voted upon by ACIP.

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Doug Campos-Outcalt, MD, MPA, is a member of the US Community Preventive Services Task Force, a clinical professor at the University of Arizona College of Medicine, and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

Dr. Campos-Outcalt was a liaison to the Advisory Committee on Immunization Practices (ACIP) representing the American Academy of Family Practitioners for 6 years. For another 4 years, he was a voting member of ACIP. During those 10 years, several of the recommendations he mentions in this audiocast were discussed and voted upon by ACIP.

Author and Disclosure Information

Doug Campos-Outcalt, MD, MPA, is a member of the US Community Preventive Services Task Force, a clinical professor at the University of Arizona College of Medicine, and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

Dr. Campos-Outcalt was a liaison to the Advisory Committee on Immunization Practices (ACIP) representing the American Academy of Family Practitioners for 6 years. For another 4 years, he was a voting member of ACIP. During those 10 years, several of the recommendations he mentions in this audiocast were discussed and voted upon by ACIP.

Resources

Liang JL, Tiwari T, Moro P, et al. Prevention of pertussis, tetanus, and diphtheria with vaccines in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2018;67:1-44.

Centers for Disease Control and Prevention. Pertussis (whooping cough). Available at: https://www.cdc.gov/pertussis/index.html. Accessed July 6, 2018.

Resources

Liang JL, Tiwari T, Moro P, et al. Prevention of pertussis, tetanus, and diphtheria with vaccines in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2018;67:1-44.

Centers for Disease Control and Prevention. Pertussis (whooping cough). Available at: https://www.cdc.gov/pertussis/index.html. Accessed July 6, 2018.

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