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New measles outbreaks reported in Los Angeles and El Paso
according to the Centers for Disease Control and Prevention.
The total number of confirmed cases of measles in the United States is now up to 1,148 for the year, which is 25 more than the previous week, the CDC said on July 22. The highest 1-week total for the year was the 90 cases reported during the week of April 11.
The number of outbreaks is back up to five as California returned to the list after a 1-week absence and El Paso, Tex., made its first appearance of the year. The current outbreak in California – the state’s fifth – is occurring in Los Angeles, which is now up to 16 total cases in 2019. El Paso just reported its fourth case on July 17, and the city’s health department noted that “it had been more than 25 years since El Paso saw its last case of measles before these four recent cases.” Outbreaks also are ongoing in Rockland County, N.Y.; New York City; and three counties in Washington State.
States that joined the ranks of the measles-infected during this most recent reporting week were Alaska and Ohio, which brings the total number to 30 for the year, the CDC said.
The Alaska Department of Health and Social Services said that it “has confirmed a single case of measles in an unvaccinated teenager from the Kenai Peninsula who recently traveled out of state to Arizona via Seattle.” The Ohio case is a “young adult from Stark County [who] recently traveled to a state with confirmed measles cases,” according to the state’s health department.
according to the Centers for Disease Control and Prevention.
The total number of confirmed cases of measles in the United States is now up to 1,148 for the year, which is 25 more than the previous week, the CDC said on July 22. The highest 1-week total for the year was the 90 cases reported during the week of April 11.
The number of outbreaks is back up to five as California returned to the list after a 1-week absence and El Paso, Tex., made its first appearance of the year. The current outbreak in California – the state’s fifth – is occurring in Los Angeles, which is now up to 16 total cases in 2019. El Paso just reported its fourth case on July 17, and the city’s health department noted that “it had been more than 25 years since El Paso saw its last case of measles before these four recent cases.” Outbreaks also are ongoing in Rockland County, N.Y.; New York City; and three counties in Washington State.
States that joined the ranks of the measles-infected during this most recent reporting week were Alaska and Ohio, which brings the total number to 30 for the year, the CDC said.
The Alaska Department of Health and Social Services said that it “has confirmed a single case of measles in an unvaccinated teenager from the Kenai Peninsula who recently traveled out of state to Arizona via Seattle.” The Ohio case is a “young adult from Stark County [who] recently traveled to a state with confirmed measles cases,” according to the state’s health department.
according to the Centers for Disease Control and Prevention.
The total number of confirmed cases of measles in the United States is now up to 1,148 for the year, which is 25 more than the previous week, the CDC said on July 22. The highest 1-week total for the year was the 90 cases reported during the week of April 11.
The number of outbreaks is back up to five as California returned to the list after a 1-week absence and El Paso, Tex., made its first appearance of the year. The current outbreak in California – the state’s fifth – is occurring in Los Angeles, which is now up to 16 total cases in 2019. El Paso just reported its fourth case on July 17, and the city’s health department noted that “it had been more than 25 years since El Paso saw its last case of measles before these four recent cases.” Outbreaks also are ongoing in Rockland County, N.Y.; New York City; and three counties in Washington State.
States that joined the ranks of the measles-infected during this most recent reporting week were Alaska and Ohio, which brings the total number to 30 for the year, the CDC said.
The Alaska Department of Health and Social Services said that it “has confirmed a single case of measles in an unvaccinated teenager from the Kenai Peninsula who recently traveled out of state to Arizona via Seattle.” The Ohio case is a “young adult from Stark County [who] recently traveled to a state with confirmed measles cases,” according to the state’s health department.
Adjuvanted flu vaccine performs better than others in young children
according to an industry-funded synthesis of six studies.
The vaccine “offers significant advances over conventional inactivated influenza vaccines and presents an acceptable safety profile in children 6 months through 5 years of age,” Sanjay S. Patel, PhD, of Novartis Vaccines and Diagnostics, Cambridge, Mass., and associates wrote in the analysis, published in the International Journal of Infectious Diseases. “The noteworthy increases in antibody responses and decreases in influenza cases following vaccination suggest an alternative for use in a population that is heavily impacted by influenza disease.”
Children are, of course, vulnerable to flu. The Centers for Disease Control and Prevention reported that 186 children died of flu during the landmark 2017-2018 flu season. That’s the highest number of pediatric flu deaths since they became a notifiable condition in 2004 (exclusive of the 2009 pandemic, when 358 pediatric deaths were reported from April 15, 2009, to October 2, 2010).The CDC said the vaccine during that flu season had an overall effectiveness level of 40%. According to research of others, however, flu vaccines are less effective in younger children than in adolescents and adults (Vaccine. 2014;32[31]:3886-94; Cochrane Database Syst Rev. 2008. doi: 10.1002/14651858.CD004879.pub3).
Fluad – a MF59-adjuvanted inactivated trivalent seasonal influenza vaccine – is used in adults over 65 in the United States and 29 other countries, and it is approved for children aged 6 months through 23 months in Canada.
Dr. Patel and associates examined the results of six studies – one phase 1b, three phase 2, and two phase 3 – that tested Fluad with or without other vaccines in 11,942 children aged 6 months to 5 years. The studies, mostly multicenter, were conducted in various countries, mainly in Europe and South and Central America, from 2006 to 2012.
In general, children in the intervention groups in the studies received two doses of the Fluad vaccine 4 weeks apart: two 0.25-mL doses for children aged 6-35 months and two 0.5-mL doses for those aged 3 years or older. In most of the studies, parallel control groups received nonadjuvanted trivalent or quadrivalent influenza vaccines.
Most participants (93%-94%) completed the studies. Solicited adverse effects were common in all groups (72% in the Fluad group vs. 67% who received IIV3 vaccines), and generally mild to moderate and resolved in 1-3 days. Unsolicited adverse effects were similar (55% and 62%, respectively) in the two flu vaccine groups. The authors wrote that “these data reflect a safety profile consistent with other licensed inactivated influenza vaccines administered to children.”
As for results, Dr. Patel and colleagues said, “HI [hemagglutination inhibition] antibody responses to both homologous and heterologous influenza strains are higher following vaccination with aIIV3, and this increase in immunogenicity is observed across all age subgroups in children aged 6 months through 5 years, and most profound in the children 6 to 36 months.”
For example, in one of the phase 3 studies when the influenza viruses were antigenically matched (homologous) for A/H1N1 among the children aged 6-35 months seroconversion was 100% for allV3 (Fluad) and 38% for IIV3-1/IIV3-4 (trivalent/quadrivalent flu vaccines); among children aged 3-5 years seroconversion was 100% for allV3 and 82% for IIV3-1/IIV3-4. For AH3N2 homologous among children aged 6-35 months, seroconversion was 98% for allV3 and 44% for IIV3-1/IIV3-4. For the B strain homologous among children aged 6-35 months, seroconversion was 88% for allV3 and 19% for IIV3-1/IIV3-4; among children aged 3-5 years seroconversion for B was 99% for allV3 and 59% for IIV3-1/IIV3-4.
In the same study when the influenza viruses were antigenically mismatched (heterologous) for A/H1N1 among children of all ages 6 months to greater than 72 months, seroconversion was 96% for allV3 (Fluad) and 44% for IIV3-1/IIV3-4; for A/H3N2 it was 98% for allV3 and 49% for IIV3-1/IIV3-4, and for the B strain it was 10% for allV3 and 3% for IIV3-1/IIV3-4.
They added that “in addition, aIIV3 had the fastest onset of immunogenicity and longest persistence of immune response, which has implications for the real-world clinical setting, where the influenza season might start earlier than expected or last longer, and second (follow-up) vaccinations may be missed.”
Dr. Patel and associates said the MF59 adjuvant in Fluad “recruits immune cells (primarily monocytes, macrophages, neutrophils, and dendritic cells) at the site of injection and differentiates them into antigen-presenting cells. With an MF59-adjuvanted vaccine, more antigen is transported from the injection site to the draining lymph node, wherein MF59 leads to T-cell activation and an increased B-cell expansion and a greater number and diversity of antibodies.”
According to goodrx.com, one syringe of Fluad 0.5 mL costs $45-$74 with coupon. The same dose of Fluzone Quadrivalent, a flu vaccine recently approved by the Food and Drug Administration for use in young children aged 6-35 months, costs $31 with coupon.
The study was funded by Novartis Vaccines and Diagnostics and Seqirus (formerly part of Novartis Vaccines and Diagnostics). The study authors disclosed employment by Novartis and Seqirus.
SOURCE: Patel SS et al. Int J Infect Dis. 2019. doi: 10.1016/j.ijid.2019.05.009.
according to an industry-funded synthesis of six studies.
The vaccine “offers significant advances over conventional inactivated influenza vaccines and presents an acceptable safety profile in children 6 months through 5 years of age,” Sanjay S. Patel, PhD, of Novartis Vaccines and Diagnostics, Cambridge, Mass., and associates wrote in the analysis, published in the International Journal of Infectious Diseases. “The noteworthy increases in antibody responses and decreases in influenza cases following vaccination suggest an alternative for use in a population that is heavily impacted by influenza disease.”
Children are, of course, vulnerable to flu. The Centers for Disease Control and Prevention reported that 186 children died of flu during the landmark 2017-2018 flu season. That’s the highest number of pediatric flu deaths since they became a notifiable condition in 2004 (exclusive of the 2009 pandemic, when 358 pediatric deaths were reported from April 15, 2009, to October 2, 2010).The CDC said the vaccine during that flu season had an overall effectiveness level of 40%. According to research of others, however, flu vaccines are less effective in younger children than in adolescents and adults (Vaccine. 2014;32[31]:3886-94; Cochrane Database Syst Rev. 2008. doi: 10.1002/14651858.CD004879.pub3).
Fluad – a MF59-adjuvanted inactivated trivalent seasonal influenza vaccine – is used in adults over 65 in the United States and 29 other countries, and it is approved for children aged 6 months through 23 months in Canada.
Dr. Patel and associates examined the results of six studies – one phase 1b, three phase 2, and two phase 3 – that tested Fluad with or without other vaccines in 11,942 children aged 6 months to 5 years. The studies, mostly multicenter, were conducted in various countries, mainly in Europe and South and Central America, from 2006 to 2012.
In general, children in the intervention groups in the studies received two doses of the Fluad vaccine 4 weeks apart: two 0.25-mL doses for children aged 6-35 months and two 0.5-mL doses for those aged 3 years or older. In most of the studies, parallel control groups received nonadjuvanted trivalent or quadrivalent influenza vaccines.
Most participants (93%-94%) completed the studies. Solicited adverse effects were common in all groups (72% in the Fluad group vs. 67% who received IIV3 vaccines), and generally mild to moderate and resolved in 1-3 days. Unsolicited adverse effects were similar (55% and 62%, respectively) in the two flu vaccine groups. The authors wrote that “these data reflect a safety profile consistent with other licensed inactivated influenza vaccines administered to children.”
As for results, Dr. Patel and colleagues said, “HI [hemagglutination inhibition] antibody responses to both homologous and heterologous influenza strains are higher following vaccination with aIIV3, and this increase in immunogenicity is observed across all age subgroups in children aged 6 months through 5 years, and most profound in the children 6 to 36 months.”
For example, in one of the phase 3 studies when the influenza viruses were antigenically matched (homologous) for A/H1N1 among the children aged 6-35 months seroconversion was 100% for allV3 (Fluad) and 38% for IIV3-1/IIV3-4 (trivalent/quadrivalent flu vaccines); among children aged 3-5 years seroconversion was 100% for allV3 and 82% for IIV3-1/IIV3-4. For AH3N2 homologous among children aged 6-35 months, seroconversion was 98% for allV3 and 44% for IIV3-1/IIV3-4. For the B strain homologous among children aged 6-35 months, seroconversion was 88% for allV3 and 19% for IIV3-1/IIV3-4; among children aged 3-5 years seroconversion for B was 99% for allV3 and 59% for IIV3-1/IIV3-4.
In the same study when the influenza viruses were antigenically mismatched (heterologous) for A/H1N1 among children of all ages 6 months to greater than 72 months, seroconversion was 96% for allV3 (Fluad) and 44% for IIV3-1/IIV3-4; for A/H3N2 it was 98% for allV3 and 49% for IIV3-1/IIV3-4, and for the B strain it was 10% for allV3 and 3% for IIV3-1/IIV3-4.
They added that “in addition, aIIV3 had the fastest onset of immunogenicity and longest persistence of immune response, which has implications for the real-world clinical setting, where the influenza season might start earlier than expected or last longer, and second (follow-up) vaccinations may be missed.”
Dr. Patel and associates said the MF59 adjuvant in Fluad “recruits immune cells (primarily monocytes, macrophages, neutrophils, and dendritic cells) at the site of injection and differentiates them into antigen-presenting cells. With an MF59-adjuvanted vaccine, more antigen is transported from the injection site to the draining lymph node, wherein MF59 leads to T-cell activation and an increased B-cell expansion and a greater number and diversity of antibodies.”
According to goodrx.com, one syringe of Fluad 0.5 mL costs $45-$74 with coupon. The same dose of Fluzone Quadrivalent, a flu vaccine recently approved by the Food and Drug Administration for use in young children aged 6-35 months, costs $31 with coupon.
The study was funded by Novartis Vaccines and Diagnostics and Seqirus (formerly part of Novartis Vaccines and Diagnostics). The study authors disclosed employment by Novartis and Seqirus.
SOURCE: Patel SS et al. Int J Infect Dis. 2019. doi: 10.1016/j.ijid.2019.05.009.
according to an industry-funded synthesis of six studies.
The vaccine “offers significant advances over conventional inactivated influenza vaccines and presents an acceptable safety profile in children 6 months through 5 years of age,” Sanjay S. Patel, PhD, of Novartis Vaccines and Diagnostics, Cambridge, Mass., and associates wrote in the analysis, published in the International Journal of Infectious Diseases. “The noteworthy increases in antibody responses and decreases in influenza cases following vaccination suggest an alternative for use in a population that is heavily impacted by influenza disease.”
Children are, of course, vulnerable to flu. The Centers for Disease Control and Prevention reported that 186 children died of flu during the landmark 2017-2018 flu season. That’s the highest number of pediatric flu deaths since they became a notifiable condition in 2004 (exclusive of the 2009 pandemic, when 358 pediatric deaths were reported from April 15, 2009, to October 2, 2010).The CDC said the vaccine during that flu season had an overall effectiveness level of 40%. According to research of others, however, flu vaccines are less effective in younger children than in adolescents and adults (Vaccine. 2014;32[31]:3886-94; Cochrane Database Syst Rev. 2008. doi: 10.1002/14651858.CD004879.pub3).
Fluad – a MF59-adjuvanted inactivated trivalent seasonal influenza vaccine – is used in adults over 65 in the United States and 29 other countries, and it is approved for children aged 6 months through 23 months in Canada.
Dr. Patel and associates examined the results of six studies – one phase 1b, three phase 2, and two phase 3 – that tested Fluad with or without other vaccines in 11,942 children aged 6 months to 5 years. The studies, mostly multicenter, were conducted in various countries, mainly in Europe and South and Central America, from 2006 to 2012.
In general, children in the intervention groups in the studies received two doses of the Fluad vaccine 4 weeks apart: two 0.25-mL doses for children aged 6-35 months and two 0.5-mL doses for those aged 3 years or older. In most of the studies, parallel control groups received nonadjuvanted trivalent or quadrivalent influenza vaccines.
Most participants (93%-94%) completed the studies. Solicited adverse effects were common in all groups (72% in the Fluad group vs. 67% who received IIV3 vaccines), and generally mild to moderate and resolved in 1-3 days. Unsolicited adverse effects were similar (55% and 62%, respectively) in the two flu vaccine groups. The authors wrote that “these data reflect a safety profile consistent with other licensed inactivated influenza vaccines administered to children.”
As for results, Dr. Patel and colleagues said, “HI [hemagglutination inhibition] antibody responses to both homologous and heterologous influenza strains are higher following vaccination with aIIV3, and this increase in immunogenicity is observed across all age subgroups in children aged 6 months through 5 years, and most profound in the children 6 to 36 months.”
For example, in one of the phase 3 studies when the influenza viruses were antigenically matched (homologous) for A/H1N1 among the children aged 6-35 months seroconversion was 100% for allV3 (Fluad) and 38% for IIV3-1/IIV3-4 (trivalent/quadrivalent flu vaccines); among children aged 3-5 years seroconversion was 100% for allV3 and 82% for IIV3-1/IIV3-4. For AH3N2 homologous among children aged 6-35 months, seroconversion was 98% for allV3 and 44% for IIV3-1/IIV3-4. For the B strain homologous among children aged 6-35 months, seroconversion was 88% for allV3 and 19% for IIV3-1/IIV3-4; among children aged 3-5 years seroconversion for B was 99% for allV3 and 59% for IIV3-1/IIV3-4.
In the same study when the influenza viruses were antigenically mismatched (heterologous) for A/H1N1 among children of all ages 6 months to greater than 72 months, seroconversion was 96% for allV3 (Fluad) and 44% for IIV3-1/IIV3-4; for A/H3N2 it was 98% for allV3 and 49% for IIV3-1/IIV3-4, and for the B strain it was 10% for allV3 and 3% for IIV3-1/IIV3-4.
They added that “in addition, aIIV3 had the fastest onset of immunogenicity and longest persistence of immune response, which has implications for the real-world clinical setting, where the influenza season might start earlier than expected or last longer, and second (follow-up) vaccinations may be missed.”
Dr. Patel and associates said the MF59 adjuvant in Fluad “recruits immune cells (primarily monocytes, macrophages, neutrophils, and dendritic cells) at the site of injection and differentiates them into antigen-presenting cells. With an MF59-adjuvanted vaccine, more antigen is transported from the injection site to the draining lymph node, wherein MF59 leads to T-cell activation and an increased B-cell expansion and a greater number and diversity of antibodies.”
According to goodrx.com, one syringe of Fluad 0.5 mL costs $45-$74 with coupon. The same dose of Fluzone Quadrivalent, a flu vaccine recently approved by the Food and Drug Administration for use in young children aged 6-35 months, costs $31 with coupon.
The study was funded by Novartis Vaccines and Diagnostics and Seqirus (formerly part of Novartis Vaccines and Diagnostics). The study authors disclosed employment by Novartis and Seqirus.
SOURCE: Patel SS et al. Int J Infect Dis. 2019. doi: 10.1016/j.ijid.2019.05.009.
FROM INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES
Adjuvanted influenza vaccine appears safe for at-risk children
according to a study in the International Journal of Infectious Diseases.
Sanjay S. Patel, PhD, of Novartis Vaccines and Diagnostics, Cambridge, Mass., and colleagues performed a retrospective analysis on an integrated dataset that drew from six randomized clinical trials comparing aIIV3 with nonadjuvanted trivalent inactivated influenza vaccine (IIV3). The dataset comprised 10,794 patients aged 6 months through 5 years, of whom 373 (3%) were deemed at risk of influenza complications after review of their medical history for conditions such as heart disease, asthma, and endocrine disorders.
The rates of solicited adverse events (such as erythema, diarrhea, fever, and localized swelling) were 74% in the aIIV3 group and 73% in the IIV3 group. The rates for any unsolicited adverse events (such as upper respiratory tract infection) for aIIV3 and IIV3 were 54% and 59%, respectively (Int J Infect Dis. 2019. doi: 10.1016/j.ijid.2019.04.023).
One of the six studies included in the dataset randomized 2,655 children for immunogenicity analyses, of whom 103 (4%) were deemed at risk. Hemagglutination inhibition assay geometric mean titers against homologous A/H1N1, A/H3N2, and B strains 21 days after the second of two doses of vaccines were two to three times higher in the aIIV3 than in the IIV3 group, which suggests that aIIV3 is more immunogenic than IIV3. As the investigators noted, this is likely because the adjuvanted vaccine induces a greater magnitude of immune response to the vaccine, something already lower in children than in adults, as well as more breadth of response, meaning the response goes beyond strains included in the vaccines.
The small number of at-risk children in the study poses a limitation on its findings. Dr. Patel and associates said that, regardless, the results of immunogenicity analyses were strong. “Overall, this analysis indicates that aIIV3 has a similar safety profile in young children with underlying medical conditions, consistent with other licensed inactivated influenza vaccines.”
Novartis Vaccines and Diagnostics originally funded the study, but was later acquired by CSL Group and now operates as Seqirus, which continued funding for the study. The authors were employees of one or the other of these companies.
according to a study in the International Journal of Infectious Diseases.
Sanjay S. Patel, PhD, of Novartis Vaccines and Diagnostics, Cambridge, Mass., and colleagues performed a retrospective analysis on an integrated dataset that drew from six randomized clinical trials comparing aIIV3 with nonadjuvanted trivalent inactivated influenza vaccine (IIV3). The dataset comprised 10,794 patients aged 6 months through 5 years, of whom 373 (3%) were deemed at risk of influenza complications after review of their medical history for conditions such as heart disease, asthma, and endocrine disorders.
The rates of solicited adverse events (such as erythema, diarrhea, fever, and localized swelling) were 74% in the aIIV3 group and 73% in the IIV3 group. The rates for any unsolicited adverse events (such as upper respiratory tract infection) for aIIV3 and IIV3 were 54% and 59%, respectively (Int J Infect Dis. 2019. doi: 10.1016/j.ijid.2019.04.023).
One of the six studies included in the dataset randomized 2,655 children for immunogenicity analyses, of whom 103 (4%) were deemed at risk. Hemagglutination inhibition assay geometric mean titers against homologous A/H1N1, A/H3N2, and B strains 21 days after the second of two doses of vaccines were two to three times higher in the aIIV3 than in the IIV3 group, which suggests that aIIV3 is more immunogenic than IIV3. As the investigators noted, this is likely because the adjuvanted vaccine induces a greater magnitude of immune response to the vaccine, something already lower in children than in adults, as well as more breadth of response, meaning the response goes beyond strains included in the vaccines.
The small number of at-risk children in the study poses a limitation on its findings. Dr. Patel and associates said that, regardless, the results of immunogenicity analyses were strong. “Overall, this analysis indicates that aIIV3 has a similar safety profile in young children with underlying medical conditions, consistent with other licensed inactivated influenza vaccines.”
Novartis Vaccines and Diagnostics originally funded the study, but was later acquired by CSL Group and now operates as Seqirus, which continued funding for the study. The authors were employees of one or the other of these companies.
according to a study in the International Journal of Infectious Diseases.
Sanjay S. Patel, PhD, of Novartis Vaccines and Diagnostics, Cambridge, Mass., and colleagues performed a retrospective analysis on an integrated dataset that drew from six randomized clinical trials comparing aIIV3 with nonadjuvanted trivalent inactivated influenza vaccine (IIV3). The dataset comprised 10,794 patients aged 6 months through 5 years, of whom 373 (3%) were deemed at risk of influenza complications after review of their medical history for conditions such as heart disease, asthma, and endocrine disorders.
The rates of solicited adverse events (such as erythema, diarrhea, fever, and localized swelling) were 74% in the aIIV3 group and 73% in the IIV3 group. The rates for any unsolicited adverse events (such as upper respiratory tract infection) for aIIV3 and IIV3 were 54% and 59%, respectively (Int J Infect Dis. 2019. doi: 10.1016/j.ijid.2019.04.023).
One of the six studies included in the dataset randomized 2,655 children for immunogenicity analyses, of whom 103 (4%) were deemed at risk. Hemagglutination inhibition assay geometric mean titers against homologous A/H1N1, A/H3N2, and B strains 21 days after the second of two doses of vaccines were two to three times higher in the aIIV3 than in the IIV3 group, which suggests that aIIV3 is more immunogenic than IIV3. As the investigators noted, this is likely because the adjuvanted vaccine induces a greater magnitude of immune response to the vaccine, something already lower in children than in adults, as well as more breadth of response, meaning the response goes beyond strains included in the vaccines.
The small number of at-risk children in the study poses a limitation on its findings. Dr. Patel and associates said that, regardless, the results of immunogenicity analyses were strong. “Overall, this analysis indicates that aIIV3 has a similar safety profile in young children with underlying medical conditions, consistent with other licensed inactivated influenza vaccines.”
Novartis Vaccines and Diagnostics originally funded the study, but was later acquired by CSL Group and now operates as Seqirus, which continued funding for the study. The authors were employees of one or the other of these companies.
FROM THE INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES
New oral polio vaccine is noninferior to currently licensed vaccine
according to Khalequ Zaman, MBBS, PhD, of the International Center for Diarrheal Disease Research in Dhaka, Bangladesh, and associates.
In the first part of the observer-blind, randomized, controlled study, 40 patients aged 5-6 years received either the new vaccine (BBio bOPV) or the licensed vaccine (SII bOPV). In the second part, 1,080 patients aged 6-8 weeks received either BBio bOPV or SII bOPV at age 6, 10, and 14 weeks. Blood samples were taken to assess neutralizing antibody responses against poliovirus types 1 and 3, and safety also was assessed.
In the first part of the study, 12 adverse events were reported, none of which were serious and none of which were related to the vaccines. All participants demonstrated seroprotective titers against both poliovirus types 1 month after vaccination.
In the second part, more than 96% of infants demonstrated seroprotection and seroconversion against both poliovirus types. Geometric mean titers were equivalent in both groups. A total of 387 participants had at least one adverse event, and 18 serious adverse events were reported. None of these were related to the vaccines.
“The BBio bOPV has been proven safe and immunogenic in the target infant population in Bangladesh. As the use of bOPV is expected to be continued until at least 2022, availability of new bOPV bulk manufacturer will be helpful in securing adequate supplies of bOPV for global demand in the polio endgame strategy,” the investigators concluded.
The study was funded by Bilthoven Biologicals. Four coauthors are employed by Bilthoven, manufacturer of the study vaccine; two others are employed by the Serum Institute of India, which provided the control vaccine.
SOURCE: Zaman K et al. Vaccine. 2019 Jun 22. doi: 10.1016/j.vaccine.2019.06.048.
according to Khalequ Zaman, MBBS, PhD, of the International Center for Diarrheal Disease Research in Dhaka, Bangladesh, and associates.
In the first part of the observer-blind, randomized, controlled study, 40 patients aged 5-6 years received either the new vaccine (BBio bOPV) or the licensed vaccine (SII bOPV). In the second part, 1,080 patients aged 6-8 weeks received either BBio bOPV or SII bOPV at age 6, 10, and 14 weeks. Blood samples were taken to assess neutralizing antibody responses against poliovirus types 1 and 3, and safety also was assessed.
In the first part of the study, 12 adverse events were reported, none of which were serious and none of which were related to the vaccines. All participants demonstrated seroprotective titers against both poliovirus types 1 month after vaccination.
In the second part, more than 96% of infants demonstrated seroprotection and seroconversion against both poliovirus types. Geometric mean titers were equivalent in both groups. A total of 387 participants had at least one adverse event, and 18 serious adverse events were reported. None of these were related to the vaccines.
“The BBio bOPV has been proven safe and immunogenic in the target infant population in Bangladesh. As the use of bOPV is expected to be continued until at least 2022, availability of new bOPV bulk manufacturer will be helpful in securing adequate supplies of bOPV for global demand in the polio endgame strategy,” the investigators concluded.
The study was funded by Bilthoven Biologicals. Four coauthors are employed by Bilthoven, manufacturer of the study vaccine; two others are employed by the Serum Institute of India, which provided the control vaccine.
SOURCE: Zaman K et al. Vaccine. 2019 Jun 22. doi: 10.1016/j.vaccine.2019.06.048.
according to Khalequ Zaman, MBBS, PhD, of the International Center for Diarrheal Disease Research in Dhaka, Bangladesh, and associates.
In the first part of the observer-blind, randomized, controlled study, 40 patients aged 5-6 years received either the new vaccine (BBio bOPV) or the licensed vaccine (SII bOPV). In the second part, 1,080 patients aged 6-8 weeks received either BBio bOPV or SII bOPV at age 6, 10, and 14 weeks. Blood samples were taken to assess neutralizing antibody responses against poliovirus types 1 and 3, and safety also was assessed.
In the first part of the study, 12 adverse events were reported, none of which were serious and none of which were related to the vaccines. All participants demonstrated seroprotective titers against both poliovirus types 1 month after vaccination.
In the second part, more than 96% of infants demonstrated seroprotection and seroconversion against both poliovirus types. Geometric mean titers were equivalent in both groups. A total of 387 participants had at least one adverse event, and 18 serious adverse events were reported. None of these were related to the vaccines.
“The BBio bOPV has been proven safe and immunogenic in the target infant population in Bangladesh. As the use of bOPV is expected to be continued until at least 2022, availability of new bOPV bulk manufacturer will be helpful in securing adequate supplies of bOPV for global demand in the polio endgame strategy,” the investigators concluded.
The study was funded by Bilthoven Biologicals. Four coauthors are employed by Bilthoven, manufacturer of the study vaccine; two others are employed by the Serum Institute of India, which provided the control vaccine.
SOURCE: Zaman K et al. Vaccine. 2019 Jun 22. doi: 10.1016/j.vaccine.2019.06.048.
FROM VACCINE
New scale could measure vaccine hesitancy in developing countries
By measuring parents’ attitudes regarding disease salience and community benefit, high scores on a four-item scale was associated with fivefold greater likelihood of not fully vaccinating their children, according to a study published in the Pediatric Infectious Disease Journal.
Mohammad Tahir Yousafzai, MPH, of Aga Khan University, Karachi, Pakistan, and colleagues developed a larger 14-item scale to measure parental attitudes and surveyed 901 households in the Sindh province of Pakistan during 2014. Part of this scale was a short 4-item subscale focusing on disease salience and community benefit, whereas the remaining 10 items form another subscale that measures parents’ perceptions and concerns regarding vaccines directly. The items are presented as 1-5 Likert scales, and scoring higher represents holding more negative attitudes regarding vaccines.
Of the 901 households surveyed, 25% of children were fully vaccinated, which meant children received all primary vaccines up to 14 weeks of age, and 54% were partially vaccinated, which meant at least one of those primary vaccines had been missed. The remaining 21% were unvaccinated.
High scores on the full 14-item scale showed some correlation with no vaccination versus partial or full vaccination (odds ratio, 3.05; 95% confidence interval, 1.75-5.31); the association disappeared after adjustment for children’s age and gender. The subscales performed better after adjustment: The adjusted ORs were 1.52 (95% CI, 1.05-2.21) for the longer subscale and 5.21 (95% CI, 3.60-7.55) for the shorter subscale. The data also showed high association between high scores on the shorter subscale and the likelihood of no or only partial vaccination (aOR, 9.65; 95% CI, 4.81-19.37).
The researchers noted that most similar scales used in developed countries are longer (10 or more items) and have lower internal consistency. This four-item scale, on the other hand, may be especially useful among lower-income populations and those in developing areas that have lower literacy rates.
One of the limitations of the study was that it was conducted only in Pakistan and not multiple developing countries; the researchers acknowledged this could limit generalizability. Another limitation is that the study size was too small for subdomain analysis; the researchers wrote that, although a lack of such analysis is unfortunate, it shouldn’t hamper the shorter subscale’s usability. A further limitation is that there was little variability across Likert scores – mostly answers at the extreme ends rather than a mix. This suggests that interviewees may not have understood how Likert scales work and therefore may not have answered accurately, noted the researchers, who employed a visual chart, trained interviewers, and field monitoring to mitigate this possibility.
“Measurement of the parental attitudes toward childhood vaccination is very important for the appropriate planning of strategies for increasing vaccine coverage and for monitoring,” they wrote.
The study was sponsored by Gavi, The Vaccine Alliance. The authors had no funding or conflicts of interest to disclose.
SOURCE: Yousafzai MT et al. Pediatr Infect Dis J. 2019 Jul;38(7):e143-8.
By measuring parents’ attitudes regarding disease salience and community benefit, high scores on a four-item scale was associated with fivefold greater likelihood of not fully vaccinating their children, according to a study published in the Pediatric Infectious Disease Journal.
Mohammad Tahir Yousafzai, MPH, of Aga Khan University, Karachi, Pakistan, and colleagues developed a larger 14-item scale to measure parental attitudes and surveyed 901 households in the Sindh province of Pakistan during 2014. Part of this scale was a short 4-item subscale focusing on disease salience and community benefit, whereas the remaining 10 items form another subscale that measures parents’ perceptions and concerns regarding vaccines directly. The items are presented as 1-5 Likert scales, and scoring higher represents holding more negative attitudes regarding vaccines.
Of the 901 households surveyed, 25% of children were fully vaccinated, which meant children received all primary vaccines up to 14 weeks of age, and 54% were partially vaccinated, which meant at least one of those primary vaccines had been missed. The remaining 21% were unvaccinated.
High scores on the full 14-item scale showed some correlation with no vaccination versus partial or full vaccination (odds ratio, 3.05; 95% confidence interval, 1.75-5.31); the association disappeared after adjustment for children’s age and gender. The subscales performed better after adjustment: The adjusted ORs were 1.52 (95% CI, 1.05-2.21) for the longer subscale and 5.21 (95% CI, 3.60-7.55) for the shorter subscale. The data also showed high association between high scores on the shorter subscale and the likelihood of no or only partial vaccination (aOR, 9.65; 95% CI, 4.81-19.37).
The researchers noted that most similar scales used in developed countries are longer (10 or more items) and have lower internal consistency. This four-item scale, on the other hand, may be especially useful among lower-income populations and those in developing areas that have lower literacy rates.
One of the limitations of the study was that it was conducted only in Pakistan and not multiple developing countries; the researchers acknowledged this could limit generalizability. Another limitation is that the study size was too small for subdomain analysis; the researchers wrote that, although a lack of such analysis is unfortunate, it shouldn’t hamper the shorter subscale’s usability. A further limitation is that there was little variability across Likert scores – mostly answers at the extreme ends rather than a mix. This suggests that interviewees may not have understood how Likert scales work and therefore may not have answered accurately, noted the researchers, who employed a visual chart, trained interviewers, and field monitoring to mitigate this possibility.
“Measurement of the parental attitudes toward childhood vaccination is very important for the appropriate planning of strategies for increasing vaccine coverage and for monitoring,” they wrote.
The study was sponsored by Gavi, The Vaccine Alliance. The authors had no funding or conflicts of interest to disclose.
SOURCE: Yousafzai MT et al. Pediatr Infect Dis J. 2019 Jul;38(7):e143-8.
By measuring parents’ attitudes regarding disease salience and community benefit, high scores on a four-item scale was associated with fivefold greater likelihood of not fully vaccinating their children, according to a study published in the Pediatric Infectious Disease Journal.
Mohammad Tahir Yousafzai, MPH, of Aga Khan University, Karachi, Pakistan, and colleagues developed a larger 14-item scale to measure parental attitudes and surveyed 901 households in the Sindh province of Pakistan during 2014. Part of this scale was a short 4-item subscale focusing on disease salience and community benefit, whereas the remaining 10 items form another subscale that measures parents’ perceptions and concerns regarding vaccines directly. The items are presented as 1-5 Likert scales, and scoring higher represents holding more negative attitudes regarding vaccines.
Of the 901 households surveyed, 25% of children were fully vaccinated, which meant children received all primary vaccines up to 14 weeks of age, and 54% were partially vaccinated, which meant at least one of those primary vaccines had been missed. The remaining 21% were unvaccinated.
High scores on the full 14-item scale showed some correlation with no vaccination versus partial or full vaccination (odds ratio, 3.05; 95% confidence interval, 1.75-5.31); the association disappeared after adjustment for children’s age and gender. The subscales performed better after adjustment: The adjusted ORs were 1.52 (95% CI, 1.05-2.21) for the longer subscale and 5.21 (95% CI, 3.60-7.55) for the shorter subscale. The data also showed high association between high scores on the shorter subscale and the likelihood of no or only partial vaccination (aOR, 9.65; 95% CI, 4.81-19.37).
The researchers noted that most similar scales used in developed countries are longer (10 or more items) and have lower internal consistency. This four-item scale, on the other hand, may be especially useful among lower-income populations and those in developing areas that have lower literacy rates.
One of the limitations of the study was that it was conducted only in Pakistan and not multiple developing countries; the researchers acknowledged this could limit generalizability. Another limitation is that the study size was too small for subdomain analysis; the researchers wrote that, although a lack of such analysis is unfortunate, it shouldn’t hamper the shorter subscale’s usability. A further limitation is that there was little variability across Likert scores – mostly answers at the extreme ends rather than a mix. This suggests that interviewees may not have understood how Likert scales work and therefore may not have answered accurately, noted the researchers, who employed a visual chart, trained interviewers, and field monitoring to mitigate this possibility.
“Measurement of the parental attitudes toward childhood vaccination is very important for the appropriate planning of strategies for increasing vaccine coverage and for monitoring,” they wrote.
The study was sponsored by Gavi, The Vaccine Alliance. The authors had no funding or conflicts of interest to disclose.
SOURCE: Yousafzai MT et al. Pediatr Infect Dis J. 2019 Jul;38(7):e143-8.
FROM THE PEDIATRIC INFECTIOUS DISEASE JOURNAL
Little association found between in utero H1N1 vaccine and 5-year health outcomes
according to Laura K. Walsh of the University of Ottawa and associates.
The investigators conducted a population-based retrospective cohort study from November 2009 to October 2010 of all live births within the province of Ontario. Of the 104,249 eligible live births reported to the Ontario birth registry, 31,295 were exposed to the H1N1 vaccine in utero. After adjustment, there were no significant differences in the women who did and did not receive vaccines during pregnancy, according to the study, published in the BMJ.
After a median follow-up of 5 years, 14% of children received an asthma diagnosis, with a median age at diagnosis of 1.8 years. Children were more likely to receive an asthma diagnosis if their mothers had a preexisting condition or if they were born preterm. At follow-up, 34% of children had at least one upper respiratory tract infection. Sensory disorder, neoplasm, and pediatric complex chronic condition were rare, each occurring in less than 1% of the study cohort (BMJ. 2019 Jul 10. doi: 10.1136/bmj.l4151).
No significant association was found between prenatal exposure to the H1N1 vaccine and upper or lower respiratory infections, otitis media, all infections, neoplasms, sensory disorders, rates of urgent and inpatient health services use, pediatric complex chronic conditions, or mortality. A weak but significant association was observed for asthma (adjusted hazard ratio, 1.05; 95% confidence interval, 1.02-1.09), and a weak inverse association was found for gastrointestinal infections (adjusted incidence rate ratio, 0.94; 95% CI, 0.91-0.98).
“Although we observed a small, but statistically significant, increase in pediatric asthma and a reduction in gastrointestinal infections, we are not aware of any biologic mechanisms to explain these findings. Future studies in different settings and with different influenza vaccine formulations will be important for developing the evidence base on longer-term pediatric outcomes following influenza vaccination during pregnancy,” the investigators concluded.
The study was funded by grants from the Canadian Institutes of Health Research and the Institute for Clinical Evaluative Sciences.
according to Laura K. Walsh of the University of Ottawa and associates.
The investigators conducted a population-based retrospective cohort study from November 2009 to October 2010 of all live births within the province of Ontario. Of the 104,249 eligible live births reported to the Ontario birth registry, 31,295 were exposed to the H1N1 vaccine in utero. After adjustment, there were no significant differences in the women who did and did not receive vaccines during pregnancy, according to the study, published in the BMJ.
After a median follow-up of 5 years, 14% of children received an asthma diagnosis, with a median age at diagnosis of 1.8 years. Children were more likely to receive an asthma diagnosis if their mothers had a preexisting condition or if they were born preterm. At follow-up, 34% of children had at least one upper respiratory tract infection. Sensory disorder, neoplasm, and pediatric complex chronic condition were rare, each occurring in less than 1% of the study cohort (BMJ. 2019 Jul 10. doi: 10.1136/bmj.l4151).
No significant association was found between prenatal exposure to the H1N1 vaccine and upper or lower respiratory infections, otitis media, all infections, neoplasms, sensory disorders, rates of urgent and inpatient health services use, pediatric complex chronic conditions, or mortality. A weak but significant association was observed for asthma (adjusted hazard ratio, 1.05; 95% confidence interval, 1.02-1.09), and a weak inverse association was found for gastrointestinal infections (adjusted incidence rate ratio, 0.94; 95% CI, 0.91-0.98).
“Although we observed a small, but statistically significant, increase in pediatric asthma and a reduction in gastrointestinal infections, we are not aware of any biologic mechanisms to explain these findings. Future studies in different settings and with different influenza vaccine formulations will be important for developing the evidence base on longer-term pediatric outcomes following influenza vaccination during pregnancy,” the investigators concluded.
The study was funded by grants from the Canadian Institutes of Health Research and the Institute for Clinical Evaluative Sciences.
according to Laura K. Walsh of the University of Ottawa and associates.
The investigators conducted a population-based retrospective cohort study from November 2009 to October 2010 of all live births within the province of Ontario. Of the 104,249 eligible live births reported to the Ontario birth registry, 31,295 were exposed to the H1N1 vaccine in utero. After adjustment, there were no significant differences in the women who did and did not receive vaccines during pregnancy, according to the study, published in the BMJ.
After a median follow-up of 5 years, 14% of children received an asthma diagnosis, with a median age at diagnosis of 1.8 years. Children were more likely to receive an asthma diagnosis if their mothers had a preexisting condition or if they were born preterm. At follow-up, 34% of children had at least one upper respiratory tract infection. Sensory disorder, neoplasm, and pediatric complex chronic condition were rare, each occurring in less than 1% of the study cohort (BMJ. 2019 Jul 10. doi: 10.1136/bmj.l4151).
No significant association was found between prenatal exposure to the H1N1 vaccine and upper or lower respiratory infections, otitis media, all infections, neoplasms, sensory disorders, rates of urgent and inpatient health services use, pediatric complex chronic conditions, or mortality. A weak but significant association was observed for asthma (adjusted hazard ratio, 1.05; 95% confidence interval, 1.02-1.09), and a weak inverse association was found for gastrointestinal infections (adjusted incidence rate ratio, 0.94; 95% CI, 0.91-0.98).
“Although we observed a small, but statistically significant, increase in pediatric asthma and a reduction in gastrointestinal infections, we are not aware of any biologic mechanisms to explain these findings. Future studies in different settings and with different influenza vaccine formulations will be important for developing the evidence base on longer-term pediatric outcomes following influenza vaccination during pregnancy,” the investigators concluded.
The study was funded by grants from the Canadian Institutes of Health Research and the Institute for Clinical Evaluative Sciences.
FROM THE BMJ
Measles cases have slowed but not stopped
The United States continues to slowly add new cases of measles to 2019’s postelimination-record total, but California was officially removed from the outbreak list this week, according to the Centers for Disease Control and Prevention.
That is the highest number of cases reported since measles was declared eliminated in 2000 and the most in a single year since 1992.
The end of outbreak-related activity in California leaves three locations still dealing with ongoing cases: Rockland County, N.Y.; New York City; and King, Pierce, and Snohomish Counties in Washington, the CDC said.
Those three jurisdictions currently report the following:
- reported four new cases from July 3 to July 11 and is up to 175 cases for the year.
- had one new case from July 1 to July 8 and is now at 564 for the year.
- reported two cases from July 1 to July 10 and is now at 10 for the year (the other two counties have a total of three cases). Clark County in Washington reported 71 cases in an earlier, unrelated outbreak.
The United States continues to slowly add new cases of measles to 2019’s postelimination-record total, but California was officially removed from the outbreak list this week, according to the Centers for Disease Control and Prevention.
That is the highest number of cases reported since measles was declared eliminated in 2000 and the most in a single year since 1992.
The end of outbreak-related activity in California leaves three locations still dealing with ongoing cases: Rockland County, N.Y.; New York City; and King, Pierce, and Snohomish Counties in Washington, the CDC said.
Those three jurisdictions currently report the following:
- reported four new cases from July 3 to July 11 and is up to 175 cases for the year.
- had one new case from July 1 to July 8 and is now at 564 for the year.
- reported two cases from July 1 to July 10 and is now at 10 for the year (the other two counties have a total of three cases). Clark County in Washington reported 71 cases in an earlier, unrelated outbreak.
The United States continues to slowly add new cases of measles to 2019’s postelimination-record total, but California was officially removed from the outbreak list this week, according to the Centers for Disease Control and Prevention.
That is the highest number of cases reported since measles was declared eliminated in 2000 and the most in a single year since 1992.
The end of outbreak-related activity in California leaves three locations still dealing with ongoing cases: Rockland County, N.Y.; New York City; and King, Pierce, and Snohomish Counties in Washington, the CDC said.
Those three jurisdictions currently report the following:
- reported four new cases from July 3 to July 11 and is up to 175 cases for the year.
- had one new case from July 1 to July 8 and is now at 564 for the year.
- reported two cases from July 1 to July 10 and is now at 10 for the year (the other two counties have a total of three cases). Clark County in Washington reported 71 cases in an earlier, unrelated outbreak.
Parent education improves pediatric influenza vaccination rates
according to a randomized clinical trial published in Pediatrics.
Vanessa P. Scott, MD, MS, of Columbia University, New York, and colleagues randomized 400 parent-child dyads into any of three arms: receiving a handout based on national data, receiving a handout based on local data, or receiving usual care. This convenience sample was drawn from two pediatric clinics in New York between August 2016 and March 2017.
After adjustment for parents’ education level, the trial found that parents who received either handout were significantly more likely than were those receiving usual care to vaccinate their children by the end of season (75% and 65%, respectively; adjusted odds ratio, 1.68; 95% confidence interval, 1.06-2.67), but the effects of any intervention versus those of usual care on vaccination on day of visit were not statistically significant (59% vs. 53%; aOR, 1.36; 95% CI, 0.89-2.09).The researchers had hoped that using a targeted approach based on local data would increase vaccine receipt, but that was not seen in the results.
They did find that, across all three arms in the trial, baseline parental intent to vaccinate (likely versus unlikely) was associated with vaccination rates: Both vaccination on clinic visit day (70% vs. 22%; aOR, 8.38; 95% CI, 4.85-14.34) and vaccination by end of season (87% vs. 29%; aOR, 18.26; 95% CI, 9.94-33.52) were affected.
Strengths of the study included the randomized, controlled design and assessment of baseline factors, such as intention to vaccinate, to reduce confounding effects. Limitations included use of a convenience sample, which could have introduced selection bias.
One author was an unremunerated coinvestigator of an unrelated trial that received an investigator-initiated grant from the Pfizer Medical Education Group. Two authors were funded by other grants, but no potential conflicts of interests to disclose were indicated by any of the authors in this study.
SOURCE: Scott VP et al. Pediatrics. 2019. doi: 10.1542/peds.2018-2580.
according to a randomized clinical trial published in Pediatrics.
Vanessa P. Scott, MD, MS, of Columbia University, New York, and colleagues randomized 400 parent-child dyads into any of three arms: receiving a handout based on national data, receiving a handout based on local data, or receiving usual care. This convenience sample was drawn from two pediatric clinics in New York between August 2016 and March 2017.
After adjustment for parents’ education level, the trial found that parents who received either handout were significantly more likely than were those receiving usual care to vaccinate their children by the end of season (75% and 65%, respectively; adjusted odds ratio, 1.68; 95% confidence interval, 1.06-2.67), but the effects of any intervention versus those of usual care on vaccination on day of visit were not statistically significant (59% vs. 53%; aOR, 1.36; 95% CI, 0.89-2.09).The researchers had hoped that using a targeted approach based on local data would increase vaccine receipt, but that was not seen in the results.
They did find that, across all three arms in the trial, baseline parental intent to vaccinate (likely versus unlikely) was associated with vaccination rates: Both vaccination on clinic visit day (70% vs. 22%; aOR, 8.38; 95% CI, 4.85-14.34) and vaccination by end of season (87% vs. 29%; aOR, 18.26; 95% CI, 9.94-33.52) were affected.
Strengths of the study included the randomized, controlled design and assessment of baseline factors, such as intention to vaccinate, to reduce confounding effects. Limitations included use of a convenience sample, which could have introduced selection bias.
One author was an unremunerated coinvestigator of an unrelated trial that received an investigator-initiated grant from the Pfizer Medical Education Group. Two authors were funded by other grants, but no potential conflicts of interests to disclose were indicated by any of the authors in this study.
SOURCE: Scott VP et al. Pediatrics. 2019. doi: 10.1542/peds.2018-2580.
according to a randomized clinical trial published in Pediatrics.
Vanessa P. Scott, MD, MS, of Columbia University, New York, and colleagues randomized 400 parent-child dyads into any of three arms: receiving a handout based on national data, receiving a handout based on local data, or receiving usual care. This convenience sample was drawn from two pediatric clinics in New York between August 2016 and March 2017.
After adjustment for parents’ education level, the trial found that parents who received either handout were significantly more likely than were those receiving usual care to vaccinate their children by the end of season (75% and 65%, respectively; adjusted odds ratio, 1.68; 95% confidence interval, 1.06-2.67), but the effects of any intervention versus those of usual care on vaccination on day of visit were not statistically significant (59% vs. 53%; aOR, 1.36; 95% CI, 0.89-2.09).The researchers had hoped that using a targeted approach based on local data would increase vaccine receipt, but that was not seen in the results.
They did find that, across all three arms in the trial, baseline parental intent to vaccinate (likely versus unlikely) was associated with vaccination rates: Both vaccination on clinic visit day (70% vs. 22%; aOR, 8.38; 95% CI, 4.85-14.34) and vaccination by end of season (87% vs. 29%; aOR, 18.26; 95% CI, 9.94-33.52) were affected.
Strengths of the study included the randomized, controlled design and assessment of baseline factors, such as intention to vaccinate, to reduce confounding effects. Limitations included use of a convenience sample, which could have introduced selection bias.
One author was an unremunerated coinvestigator of an unrelated trial that received an investigator-initiated grant from the Pfizer Medical Education Group. Two authors were funded by other grants, but no potential conflicts of interests to disclose were indicated by any of the authors in this study.
SOURCE: Scott VP et al. Pediatrics. 2019. doi: 10.1542/peds.2018-2580.
FROM PEDIATRICS
Recombinant vaccine cut herpes zoster rate in immunocompromised patients
Two doses of recombinant zoster vaccine significantly reduced incidence of herpes zoster in adults who had undergone autologous hematopoietic stem cell transplantation (HSCT), results of a randomized, placebo-controlled trial indicate.
The incidence of herpes zoster was 30 per 1,000 person-years for patients who received the adjuvanted recombinant zoster vaccine (Shingrix) versus 94 per 1,000 person-years for those who received placebo, according to study results.
Recombinant zoster vaccine induced humoral and cellular responses that were strong and occurring at a rate higher than what was seen in the placebo group, said senior author Keith M. Sullivan, MD, of Duke University Medical Center, Durham, N.C., and coauthors, who reported findings on behalf of the Zoster Efficacy Study in Patients Undergoing HSCT (ZOE-HSCT) Study Group.
“The vaccinations were generally well tolerated, and most symptoms were mild and transient and did not substantially deter participants from receiving their second dose,” Dr. Sullivan and colleagues wrote in JAMA.
The risk of herpes zoster is increased for 2-3 years after autologous HSCT because of diminished T-cell immunity, according to the authors.
“Antiviral prophylaxis is commonly administered to patients after HSCT to prevent such complications, but the efficacy depends on adherence to treatment,” they said.
While vaccines could provide long-term protection, immunocompromised individuals receiving live attenuated vaccine would be at increased risk of varicella caused by spread of the vaccine strain, they added.
There have been a few encouraging recent studies of non-live vaccines in this setting, including one large phase 3 trial of a heat-inactivated varicella-zoster virus vaccine that showed patients undergoing autologous HSCT had a 63.8% estimated efficacy in preventing herpes zoster, investigators from that study said in The Lancet (2018 May 26;391[10135]:2116-27).
A phase 1/2a study of the adjuvanted recombinant zoster vaccine in patients undergoing HSCT demonstrated strong humoral and cell-mediated immunity responses, which provided the rationale for studying the vaccine further in the randomized ZOE-HSCT study, according to Dr. Sullivan and coauthors.
Their study included a total of 1,846 adults who had undergone autologous HSCT. They were randomized to receive two doses of the recombinant zoster vaccine, the first at 50-70 days after the procedure and the second 1-2 months later.
Herpes zoster cases were seen in 49 and 136 individuals in the vaccine and placebo groups, respectively, which resulted in overall incidences of 30 and 94 per 1,000 person-years.
The incidence rate ratio of a first episode of herpes zoster was 0.36 for individuals receiving at least one dose, which authors said was equivalent to a vaccine efficacy of 63.7%.
That efficacy rate is “very similar” to the estimated efficacy reported for the heat-inactivated varicella-zoster virus vaccine reported in The Lancet, said Dr. Sullivan and coauthors.
However, the heat-inactivated vaccine achieved that level of protection with a four-dose schedule, including one dose given prior to autologous HSCT.
“An advantage of the short 2-dose posttransplantation schedule is that more patients might complete the vaccination program,” they said in a discussion of the results, noting that 94.7% of the recombinant zoster vaccine recipients completed two doses, compared with 81.9% of recipients who received the heat-inactivated herpes zoster vaccine in the previous report.
The study was funded and sponsored by GlaxoSmithKline Biologicals SA. Dr. Sullivan reported disclosures related to GlaxoSmithKline (GSK), Kiadis Pharmaceutical, Roche Genentech, and the National Institute of Allergy and Infectious Diseases. Coauthors provided disclosures related to GSK, AbbVie, Roche, Gilead, Janssen, Pharmacyclics, Morphosys, Helsinn, Celgene, and others.
SOURCE: Bastidas A et al. JAMA. 2019 July 9. doi: 10.1001/jama.2019.9053.
Two doses of recombinant zoster vaccine significantly reduced incidence of herpes zoster in adults who had undergone autologous hematopoietic stem cell transplantation (HSCT), results of a randomized, placebo-controlled trial indicate.
The incidence of herpes zoster was 30 per 1,000 person-years for patients who received the adjuvanted recombinant zoster vaccine (Shingrix) versus 94 per 1,000 person-years for those who received placebo, according to study results.
Recombinant zoster vaccine induced humoral and cellular responses that were strong and occurring at a rate higher than what was seen in the placebo group, said senior author Keith M. Sullivan, MD, of Duke University Medical Center, Durham, N.C., and coauthors, who reported findings on behalf of the Zoster Efficacy Study in Patients Undergoing HSCT (ZOE-HSCT) Study Group.
“The vaccinations were generally well tolerated, and most symptoms were mild and transient and did not substantially deter participants from receiving their second dose,” Dr. Sullivan and colleagues wrote in JAMA.
The risk of herpes zoster is increased for 2-3 years after autologous HSCT because of diminished T-cell immunity, according to the authors.
“Antiviral prophylaxis is commonly administered to patients after HSCT to prevent such complications, but the efficacy depends on adherence to treatment,” they said.
While vaccines could provide long-term protection, immunocompromised individuals receiving live attenuated vaccine would be at increased risk of varicella caused by spread of the vaccine strain, they added.
There have been a few encouraging recent studies of non-live vaccines in this setting, including one large phase 3 trial of a heat-inactivated varicella-zoster virus vaccine that showed patients undergoing autologous HSCT had a 63.8% estimated efficacy in preventing herpes zoster, investigators from that study said in The Lancet (2018 May 26;391[10135]:2116-27).
A phase 1/2a study of the adjuvanted recombinant zoster vaccine in patients undergoing HSCT demonstrated strong humoral and cell-mediated immunity responses, which provided the rationale for studying the vaccine further in the randomized ZOE-HSCT study, according to Dr. Sullivan and coauthors.
Their study included a total of 1,846 adults who had undergone autologous HSCT. They were randomized to receive two doses of the recombinant zoster vaccine, the first at 50-70 days after the procedure and the second 1-2 months later.
Herpes zoster cases were seen in 49 and 136 individuals in the vaccine and placebo groups, respectively, which resulted in overall incidences of 30 and 94 per 1,000 person-years.
The incidence rate ratio of a first episode of herpes zoster was 0.36 for individuals receiving at least one dose, which authors said was equivalent to a vaccine efficacy of 63.7%.
That efficacy rate is “very similar” to the estimated efficacy reported for the heat-inactivated varicella-zoster virus vaccine reported in The Lancet, said Dr. Sullivan and coauthors.
However, the heat-inactivated vaccine achieved that level of protection with a four-dose schedule, including one dose given prior to autologous HSCT.
“An advantage of the short 2-dose posttransplantation schedule is that more patients might complete the vaccination program,” they said in a discussion of the results, noting that 94.7% of the recombinant zoster vaccine recipients completed two doses, compared with 81.9% of recipients who received the heat-inactivated herpes zoster vaccine in the previous report.
The study was funded and sponsored by GlaxoSmithKline Biologicals SA. Dr. Sullivan reported disclosures related to GlaxoSmithKline (GSK), Kiadis Pharmaceutical, Roche Genentech, and the National Institute of Allergy and Infectious Diseases. Coauthors provided disclosures related to GSK, AbbVie, Roche, Gilead, Janssen, Pharmacyclics, Morphosys, Helsinn, Celgene, and others.
SOURCE: Bastidas A et al. JAMA. 2019 July 9. doi: 10.1001/jama.2019.9053.
Two doses of recombinant zoster vaccine significantly reduced incidence of herpes zoster in adults who had undergone autologous hematopoietic stem cell transplantation (HSCT), results of a randomized, placebo-controlled trial indicate.
The incidence of herpes zoster was 30 per 1,000 person-years for patients who received the adjuvanted recombinant zoster vaccine (Shingrix) versus 94 per 1,000 person-years for those who received placebo, according to study results.
Recombinant zoster vaccine induced humoral and cellular responses that were strong and occurring at a rate higher than what was seen in the placebo group, said senior author Keith M. Sullivan, MD, of Duke University Medical Center, Durham, N.C., and coauthors, who reported findings on behalf of the Zoster Efficacy Study in Patients Undergoing HSCT (ZOE-HSCT) Study Group.
“The vaccinations were generally well tolerated, and most symptoms were mild and transient and did not substantially deter participants from receiving their second dose,” Dr. Sullivan and colleagues wrote in JAMA.
The risk of herpes zoster is increased for 2-3 years after autologous HSCT because of diminished T-cell immunity, according to the authors.
“Antiviral prophylaxis is commonly administered to patients after HSCT to prevent such complications, but the efficacy depends on adherence to treatment,” they said.
While vaccines could provide long-term protection, immunocompromised individuals receiving live attenuated vaccine would be at increased risk of varicella caused by spread of the vaccine strain, they added.
There have been a few encouraging recent studies of non-live vaccines in this setting, including one large phase 3 trial of a heat-inactivated varicella-zoster virus vaccine that showed patients undergoing autologous HSCT had a 63.8% estimated efficacy in preventing herpes zoster, investigators from that study said in The Lancet (2018 May 26;391[10135]:2116-27).
A phase 1/2a study of the adjuvanted recombinant zoster vaccine in patients undergoing HSCT demonstrated strong humoral and cell-mediated immunity responses, which provided the rationale for studying the vaccine further in the randomized ZOE-HSCT study, according to Dr. Sullivan and coauthors.
Their study included a total of 1,846 adults who had undergone autologous HSCT. They were randomized to receive two doses of the recombinant zoster vaccine, the first at 50-70 days after the procedure and the second 1-2 months later.
Herpes zoster cases were seen in 49 and 136 individuals in the vaccine and placebo groups, respectively, which resulted in overall incidences of 30 and 94 per 1,000 person-years.
The incidence rate ratio of a first episode of herpes zoster was 0.36 for individuals receiving at least one dose, which authors said was equivalent to a vaccine efficacy of 63.7%.
That efficacy rate is “very similar” to the estimated efficacy reported for the heat-inactivated varicella-zoster virus vaccine reported in The Lancet, said Dr. Sullivan and coauthors.
However, the heat-inactivated vaccine achieved that level of protection with a four-dose schedule, including one dose given prior to autologous HSCT.
“An advantage of the short 2-dose posttransplantation schedule is that more patients might complete the vaccination program,” they said in a discussion of the results, noting that 94.7% of the recombinant zoster vaccine recipients completed two doses, compared with 81.9% of recipients who received the heat-inactivated herpes zoster vaccine in the previous report.
The study was funded and sponsored by GlaxoSmithKline Biologicals SA. Dr. Sullivan reported disclosures related to GlaxoSmithKline (GSK), Kiadis Pharmaceutical, Roche Genentech, and the National Institute of Allergy and Infectious Diseases. Coauthors provided disclosures related to GSK, AbbVie, Roche, Gilead, Janssen, Pharmacyclics, Morphosys, Helsinn, Celgene, and others.
SOURCE: Bastidas A et al. JAMA. 2019 July 9. doi: 10.1001/jama.2019.9053.
FROM JAMA
Key clinical point: Two doses of recombinant zoster vaccine significantly reduced incidence of herpes zoster versus placebo in adults who had undergone autologous hematopoietic stem cell transplantation (HSCT).
Major finding: Herpes zoster cases were seen in 49 and 136 individuals in the vaccine and placebo groups, respectively, resulting in overall incidences of 30 and 94 per 1,000 person-years.
Study details: A randomized clinical trial (ZOE-HSCT) including 1,846 adults who had undergone autologous HSCT.
Disclosures: The study was funded and sponsored by GlaxoSmithKline Biologicals SA. Study authors reported disclosures related to GlaxoSmithKline, Kiadis Pharmaceutical, Roche Genentech, AbbVie, Roche, Gilead, Janssen, Pharmacyclics, Morphosys, Helsinn, Celgene, and others.
Source: Bastidas A et al. JAMA. 2019 July 9. doi: 10.1001/jama.2019.9053.
Acquired MMR immunity doesn’t last to age 1 year
according to results of a study in Vaccine.
María José Cilleruelo, PhD, of Hospital Universitario Puerta de Hierro in Majadahonda, Spain, and colleagues showed that, although most infants acquire some protective antibodies against MMR from their mothers during gestation, most have lost this protection as early as 3 months of age. This single-center, observational, prospective study was conducted between October 2013 and December 2014, and it began with 146 mother-child pairs, with 99 remaining in follow-up at 3 months, 77 at 6 months, 63 at 9 months, and 30 at 12 months. For measles, 88% of newborns were seropositive, but only 19% were at 3 months; for mumps, 70% of newborns were seropositive, but only 11% were at 3 months; and for rubella, 91% of newborns were seropositive, but only 13% were at 3 months. No infants were seropositive for mumps or rubella at 9 months, and only 2% were for measles. No infants were seropositive for any of these viruses by 12 months of age.
The investigators noted that, given Spain (where the study was conducted) is a country that gives the first MMR vaccine at 12 months of life, these declining titers can leave most infants vulnerable to those viruses before then.
“We suggest that it may be worth considering administering the first dose of MMR vaccine before 12 months of age,” the investigators concluded, although they advised studies be undertaken into the efficacy and safety of administration of that vaccine in infants younger than 12 months. They noted that the biggest limitation of this study was the high percentage of loss to follow-up, which limited the statistical power to make comparisons.
The study was funded by the Fondo de Investigación Sanitaria, and one of the authors was funded by CIBER de Epidemiología y Salud Pública. The authors declared that there are no conflicts of interest.
SOURCE: Cilleruelo MJ et al. Vaccine. 2019;37:4164-71.
according to results of a study in Vaccine.
María José Cilleruelo, PhD, of Hospital Universitario Puerta de Hierro in Majadahonda, Spain, and colleagues showed that, although most infants acquire some protective antibodies against MMR from their mothers during gestation, most have lost this protection as early as 3 months of age. This single-center, observational, prospective study was conducted between October 2013 and December 2014, and it began with 146 mother-child pairs, with 99 remaining in follow-up at 3 months, 77 at 6 months, 63 at 9 months, and 30 at 12 months. For measles, 88% of newborns were seropositive, but only 19% were at 3 months; for mumps, 70% of newborns were seropositive, but only 11% were at 3 months; and for rubella, 91% of newborns were seropositive, but only 13% were at 3 months. No infants were seropositive for mumps or rubella at 9 months, and only 2% were for measles. No infants were seropositive for any of these viruses by 12 months of age.
The investigators noted that, given Spain (where the study was conducted) is a country that gives the first MMR vaccine at 12 months of life, these declining titers can leave most infants vulnerable to those viruses before then.
“We suggest that it may be worth considering administering the first dose of MMR vaccine before 12 months of age,” the investigators concluded, although they advised studies be undertaken into the efficacy and safety of administration of that vaccine in infants younger than 12 months. They noted that the biggest limitation of this study was the high percentage of loss to follow-up, which limited the statistical power to make comparisons.
The study was funded by the Fondo de Investigación Sanitaria, and one of the authors was funded by CIBER de Epidemiología y Salud Pública. The authors declared that there are no conflicts of interest.
SOURCE: Cilleruelo MJ et al. Vaccine. 2019;37:4164-71.
according to results of a study in Vaccine.
María José Cilleruelo, PhD, of Hospital Universitario Puerta de Hierro in Majadahonda, Spain, and colleagues showed that, although most infants acquire some protective antibodies against MMR from their mothers during gestation, most have lost this protection as early as 3 months of age. This single-center, observational, prospective study was conducted between October 2013 and December 2014, and it began with 146 mother-child pairs, with 99 remaining in follow-up at 3 months, 77 at 6 months, 63 at 9 months, and 30 at 12 months. For measles, 88% of newborns were seropositive, but only 19% were at 3 months; for mumps, 70% of newborns were seropositive, but only 11% were at 3 months; and for rubella, 91% of newborns were seropositive, but only 13% were at 3 months. No infants were seropositive for mumps or rubella at 9 months, and only 2% were for measles. No infants were seropositive for any of these viruses by 12 months of age.
The investigators noted that, given Spain (where the study was conducted) is a country that gives the first MMR vaccine at 12 months of life, these declining titers can leave most infants vulnerable to those viruses before then.
“We suggest that it may be worth considering administering the first dose of MMR vaccine before 12 months of age,” the investigators concluded, although they advised studies be undertaken into the efficacy and safety of administration of that vaccine in infants younger than 12 months. They noted that the biggest limitation of this study was the high percentage of loss to follow-up, which limited the statistical power to make comparisons.
The study was funded by the Fondo de Investigación Sanitaria, and one of the authors was funded by CIBER de Epidemiología y Salud Pública. The authors declared that there are no conflicts of interest.
SOURCE: Cilleruelo MJ et al. Vaccine. 2019;37:4164-71.
FROM VACCINE