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CDC monitoring 279 pregnant women in U.S. with Zika infection
More pregnant women in the United States and its territories may be at risk for Zika virus–related birth complications than previously reported, according to the Centers for Disease Control and Prevention.
As of May 12, CDC officials were monitoring 279 pregnant women with laboratory evidence of possible Zika virus infection – 157 in U.S. states and 122 in U.S. territories, according to a report published in the Morbidity and Mortality Weekly Report (2016 May 20. doi: 10.15585/mmwr.mm6520e1).
“We’ve learned a lot in the last 4 months, and now we know of reports of asymptomatic Zika infections linked to microcephaly, brain defects, and miscarriage,” Margaret Honein, Ph.D., chief of the birth defects branch at the CDC’s National Center for Birth Defects and Developmental Disabilities, said during a May 20 media briefing to announce enhanced tracking of the virus.
Recently published data indicating congenital defects in children born to mothers who had no recollection of ever having Zika-like symptoms spurred the CDC to widen its scope of data capture, Dr. Honein said.
Since February 2016, the CDC has been relying on data from the national arboviral disease surveillance system (ArboNET) to track Zika in pregnant women with symptoms of the Zika virus infection, or those with pregnancy complications consistent with the virus. Although ArboNET describes a subset of pregnancies at risk from Zika virus, it does not track actual congenital outcomes.
Now, federal health officials have created two registries solely dedicated to collecting data on birth outcomes among both symptomatic and asymptomatic women with any laboratory evidence of Zika virus infections. In the continental United States, there is the U.S. Zika Pregnancy Registry (USZPR). In Puerto Rico, there is the Zika Active Pregnancy Surveillance System (ZAPSS).
The 279 pregnant women currently being monitored reflect a broader group of pregnant women than numbers previously reported since it includes pregnant women who have any laboratory evidence of possible Zika virus infection, regardless of them being asymptomatic or whether they recalled ever having symptoms.
New figures on Zika infection in pregnancy will be posted on the CDC website each Thursday at noon EDT, and will reflect the previous week’s numbers.
“This reporting is in line with our recommendations for ongoing monitoring of pregnancies at risk for poor outcomes associated with Zika, based on our current understanding [of the virus],” Dr. Honein said. She recommended that pregnant women be tested for the virus at the start of prenatal care and again during the third trimester.The registry data will be used to determine those most at risk, characterize adverse Zika-related outcomes, and help officials plan for services needed by affected families, said Dr. Honein, encouraging all jurisdictions covered by the surveillance systems to participate in the data collection as quickly as possible.
Meanwhile, Dr. Honein said that the CDC is withholding specific information on known adverse birth outcomes in order to respect the affected families’ privacy, but did say that as of May 20, the CDC was aware of “less than a dozen adverse outcomes, including miscarriages and birth defects.”
Dr. Honein also declined to say how many of the cases reported to the registry involve sexual transmission of the virus versus actual contact with the Aedes aegypti mosquito.
On Twitter @whitneymcknight
More pregnant women in the United States and its territories may be at risk for Zika virus–related birth complications than previously reported, according to the Centers for Disease Control and Prevention.
As of May 12, CDC officials were monitoring 279 pregnant women with laboratory evidence of possible Zika virus infection – 157 in U.S. states and 122 in U.S. territories, according to a report published in the Morbidity and Mortality Weekly Report (2016 May 20. doi: 10.15585/mmwr.mm6520e1).
“We’ve learned a lot in the last 4 months, and now we know of reports of asymptomatic Zika infections linked to microcephaly, brain defects, and miscarriage,” Margaret Honein, Ph.D., chief of the birth defects branch at the CDC’s National Center for Birth Defects and Developmental Disabilities, said during a May 20 media briefing to announce enhanced tracking of the virus.
Recently published data indicating congenital defects in children born to mothers who had no recollection of ever having Zika-like symptoms spurred the CDC to widen its scope of data capture, Dr. Honein said.
Since February 2016, the CDC has been relying on data from the national arboviral disease surveillance system (ArboNET) to track Zika in pregnant women with symptoms of the Zika virus infection, or those with pregnancy complications consistent with the virus. Although ArboNET describes a subset of pregnancies at risk from Zika virus, it does not track actual congenital outcomes.
Now, federal health officials have created two registries solely dedicated to collecting data on birth outcomes among both symptomatic and asymptomatic women with any laboratory evidence of Zika virus infections. In the continental United States, there is the U.S. Zika Pregnancy Registry (USZPR). In Puerto Rico, there is the Zika Active Pregnancy Surveillance System (ZAPSS).
The 279 pregnant women currently being monitored reflect a broader group of pregnant women than numbers previously reported since it includes pregnant women who have any laboratory evidence of possible Zika virus infection, regardless of them being asymptomatic or whether they recalled ever having symptoms.
New figures on Zika infection in pregnancy will be posted on the CDC website each Thursday at noon EDT, and will reflect the previous week’s numbers.
“This reporting is in line with our recommendations for ongoing monitoring of pregnancies at risk for poor outcomes associated with Zika, based on our current understanding [of the virus],” Dr. Honein said. She recommended that pregnant women be tested for the virus at the start of prenatal care and again during the third trimester.The registry data will be used to determine those most at risk, characterize adverse Zika-related outcomes, and help officials plan for services needed by affected families, said Dr. Honein, encouraging all jurisdictions covered by the surveillance systems to participate in the data collection as quickly as possible.
Meanwhile, Dr. Honein said that the CDC is withholding specific information on known adverse birth outcomes in order to respect the affected families’ privacy, but did say that as of May 20, the CDC was aware of “less than a dozen adverse outcomes, including miscarriages and birth defects.”
Dr. Honein also declined to say how many of the cases reported to the registry involve sexual transmission of the virus versus actual contact with the Aedes aegypti mosquito.
On Twitter @whitneymcknight
More pregnant women in the United States and its territories may be at risk for Zika virus–related birth complications than previously reported, according to the Centers for Disease Control and Prevention.
As of May 12, CDC officials were monitoring 279 pregnant women with laboratory evidence of possible Zika virus infection – 157 in U.S. states and 122 in U.S. territories, according to a report published in the Morbidity and Mortality Weekly Report (2016 May 20. doi: 10.15585/mmwr.mm6520e1).
“We’ve learned a lot in the last 4 months, and now we know of reports of asymptomatic Zika infections linked to microcephaly, brain defects, and miscarriage,” Margaret Honein, Ph.D., chief of the birth defects branch at the CDC’s National Center for Birth Defects and Developmental Disabilities, said during a May 20 media briefing to announce enhanced tracking of the virus.
Recently published data indicating congenital defects in children born to mothers who had no recollection of ever having Zika-like symptoms spurred the CDC to widen its scope of data capture, Dr. Honein said.
Since February 2016, the CDC has been relying on data from the national arboviral disease surveillance system (ArboNET) to track Zika in pregnant women with symptoms of the Zika virus infection, or those with pregnancy complications consistent with the virus. Although ArboNET describes a subset of pregnancies at risk from Zika virus, it does not track actual congenital outcomes.
Now, federal health officials have created two registries solely dedicated to collecting data on birth outcomes among both symptomatic and asymptomatic women with any laboratory evidence of Zika virus infections. In the continental United States, there is the U.S. Zika Pregnancy Registry (USZPR). In Puerto Rico, there is the Zika Active Pregnancy Surveillance System (ZAPSS).
The 279 pregnant women currently being monitored reflect a broader group of pregnant women than numbers previously reported since it includes pregnant women who have any laboratory evidence of possible Zika virus infection, regardless of them being asymptomatic or whether they recalled ever having symptoms.
New figures on Zika infection in pregnancy will be posted on the CDC website each Thursday at noon EDT, and will reflect the previous week’s numbers.
“This reporting is in line with our recommendations for ongoing monitoring of pregnancies at risk for poor outcomes associated with Zika, based on our current understanding [of the virus],” Dr. Honein said. She recommended that pregnant women be tested for the virus at the start of prenatal care and again during the third trimester.The registry data will be used to determine those most at risk, characterize adverse Zika-related outcomes, and help officials plan for services needed by affected families, said Dr. Honein, encouraging all jurisdictions covered by the surveillance systems to participate in the data collection as quickly as possible.
Meanwhile, Dr. Honein said that the CDC is withholding specific information on known adverse birth outcomes in order to respect the affected families’ privacy, but did say that as of May 20, the CDC was aware of “less than a dozen adverse outcomes, including miscarriages and birth defects.”
Dr. Honein also declined to say how many of the cases reported to the registry involve sexual transmission of the virus versus actual contact with the Aedes aegypti mosquito.
On Twitter @whitneymcknight
Malaria vaccine provides long-term protection in phase I trial
A new malaria vaccine successfully protected a group of healthy United States adults from malaria for more than a year, according to Dr. Andrew Ishizuka and his associates.
In a phase I trial, 57 malaria-naive people received the PfSPZ Vaccine, which contains live but weakened Plasmodium falciparum sporozoites. Participants received either three or four intravenous doses, or four intramuscular injections with a dosage strength 10 times that of the IV immunizations, and were exposed to malaria 3 weeks after completing immunization. Participants who received the four-dose IV immunization had the highest rate of protection at 78%.
To assess long-term effectiveness of the vaccine, a group of five participants who had previously been exposed to malaria at 3 and 21 weeks post-immunization were exposed again after 59 weeks. No P. falciparum was found in the blood of these participants, while a group of six unvaccinated controls who were exposed to the parasites developed malaria.
“Malaria remains one of the most devastating diseases in the world, especially among young children in Africa. A malaria vaccine that provides long-term protection is urgently needed to reduce mortality and eliminate transmission. This study is an encouraging step forward in our goal to control and ultimately eradicate malaria,” Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a press release.
Find the study in Nature Medicine (2016 May. doi: 10.1038/nm.4110).
A new malaria vaccine successfully protected a group of healthy United States adults from malaria for more than a year, according to Dr. Andrew Ishizuka and his associates.
In a phase I trial, 57 malaria-naive people received the PfSPZ Vaccine, which contains live but weakened Plasmodium falciparum sporozoites. Participants received either three or four intravenous doses, or four intramuscular injections with a dosage strength 10 times that of the IV immunizations, and were exposed to malaria 3 weeks after completing immunization. Participants who received the four-dose IV immunization had the highest rate of protection at 78%.
To assess long-term effectiveness of the vaccine, a group of five participants who had previously been exposed to malaria at 3 and 21 weeks post-immunization were exposed again after 59 weeks. No P. falciparum was found in the blood of these participants, while a group of six unvaccinated controls who were exposed to the parasites developed malaria.
“Malaria remains one of the most devastating diseases in the world, especially among young children in Africa. A malaria vaccine that provides long-term protection is urgently needed to reduce mortality and eliminate transmission. This study is an encouraging step forward in our goal to control and ultimately eradicate malaria,” Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a press release.
Find the study in Nature Medicine (2016 May. doi: 10.1038/nm.4110).
A new malaria vaccine successfully protected a group of healthy United States adults from malaria for more than a year, according to Dr. Andrew Ishizuka and his associates.
In a phase I trial, 57 malaria-naive people received the PfSPZ Vaccine, which contains live but weakened Plasmodium falciparum sporozoites. Participants received either three or four intravenous doses, or four intramuscular injections with a dosage strength 10 times that of the IV immunizations, and were exposed to malaria 3 weeks after completing immunization. Participants who received the four-dose IV immunization had the highest rate of protection at 78%.
To assess long-term effectiveness of the vaccine, a group of five participants who had previously been exposed to malaria at 3 and 21 weeks post-immunization were exposed again after 59 weeks. No P. falciparum was found in the blood of these participants, while a group of six unvaccinated controls who were exposed to the parasites developed malaria.
“Malaria remains one of the most devastating diseases in the world, especially among young children in Africa. A malaria vaccine that provides long-term protection is urgently needed to reduce mortality and eliminate transmission. This study is an encouraging step forward in our goal to control and ultimately eradicate malaria,” Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a press release.
Find the study in Nature Medicine (2016 May. doi: 10.1038/nm.4110).
FROM NATURE MEDICINE
VIDEO: Delays in receiving Zika test results reported
WASHINGTON – The Centers for Disease Control and Prevention is recommending blood or urine testing for all pregnant women with possible Zika exposure through travel or because they live in an endemic area, regardless of whether they are symptomatic, Dr. Denise J. Jamieson said at the annual meeting of the American College of Obstetricians and Gynecologists.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Couples interested in conceiving who live in or have traveled to areas of active transmission should be alert for any signs of infection, no matter how slight; if they notice any, they should be tested for exposure before attempting conception, Dr. Jamieson, a medical officer with the CDC’s division of reproductive medicine, said in a video interview.
Unfortunately, she said at an update on the Zika situation, labs that process Zika blood and urine samples are backed up, and test results are being “unacceptably delayed.”
During a discussion period, some physicians in the audience complained of waiting up to 6 weeks for results. One said a local health department official told him that the CDC had a backlog of “a million tests.”
“We do not have a 1-million test backup,” Dr. Jamieson said. “But in some places there are still unacceptably long delays. This is not a test you can just check off on a form and send to a lab.”
Many of the tests are being funneled to the CDC’s Division of Vector-Borne Diseases in Ft. Collins, Colo.; that facility is experiencing a long turnaround time. Other samples are being handled in private labs with CDC contracts, but Dr. Jamieson said there’s an urgent need to expand the testing to many more commercial labs. There is no concrete plan for how or when this expansion will happen, however, she added.
Dr. Jamieson also discussed the CDC’s recommendation for managing pregnant women who have a positive serology or urine. These women should have serial ultrasounds every 3-4 weeks to track fetal brain development. Amniocentesis can positively confirm fetal exposure. A maternal-fetal medicine specialist should be on board if the fetus tests positive or if any concerning signs appear on imaging. Newborns can also be tested for exposure, as can placental and cord tissue.
On May 16, the World Health Organization released a comprehensive document describing a management algorithm for pregnant women who live in or travel to Zika-endemic areas.
Women who haven’t experienced signs and symptoms of an infection can proceed with routine care, and, if possible, an ultrasound before 18 weeks’ gestation and another at 28-30 weeks.
Women who have had signs of an infection should be tested for exposure. If negative, routine care with an early ultrasound and one at 28-30 weeks is indicated. If the results are positive, or if an early scan is concerning, patients should have a diagnostic ultrasound and amniocentesis, with referral to specialty care.
In the case of confirmed maternal exposure but normal early ultrasound, serial scans are indicated every month until delivery.
As a federal employee, Dr. Jamieson has no financial disclosures.
WASHINGTON – The Centers for Disease Control and Prevention is recommending blood or urine testing for all pregnant women with possible Zika exposure through travel or because they live in an endemic area, regardless of whether they are symptomatic, Dr. Denise J. Jamieson said at the annual meeting of the American College of Obstetricians and Gynecologists.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Couples interested in conceiving who live in or have traveled to areas of active transmission should be alert for any signs of infection, no matter how slight; if they notice any, they should be tested for exposure before attempting conception, Dr. Jamieson, a medical officer with the CDC’s division of reproductive medicine, said in a video interview.
Unfortunately, she said at an update on the Zika situation, labs that process Zika blood and urine samples are backed up, and test results are being “unacceptably delayed.”
During a discussion period, some physicians in the audience complained of waiting up to 6 weeks for results. One said a local health department official told him that the CDC had a backlog of “a million tests.”
“We do not have a 1-million test backup,” Dr. Jamieson said. “But in some places there are still unacceptably long delays. This is not a test you can just check off on a form and send to a lab.”
Many of the tests are being funneled to the CDC’s Division of Vector-Borne Diseases in Ft. Collins, Colo.; that facility is experiencing a long turnaround time. Other samples are being handled in private labs with CDC contracts, but Dr. Jamieson said there’s an urgent need to expand the testing to many more commercial labs. There is no concrete plan for how or when this expansion will happen, however, she added.
Dr. Jamieson also discussed the CDC’s recommendation for managing pregnant women who have a positive serology or urine. These women should have serial ultrasounds every 3-4 weeks to track fetal brain development. Amniocentesis can positively confirm fetal exposure. A maternal-fetal medicine specialist should be on board if the fetus tests positive or if any concerning signs appear on imaging. Newborns can also be tested for exposure, as can placental and cord tissue.
On May 16, the World Health Organization released a comprehensive document describing a management algorithm for pregnant women who live in or travel to Zika-endemic areas.
Women who haven’t experienced signs and symptoms of an infection can proceed with routine care, and, if possible, an ultrasound before 18 weeks’ gestation and another at 28-30 weeks.
Women who have had signs of an infection should be tested for exposure. If negative, routine care with an early ultrasound and one at 28-30 weeks is indicated. If the results are positive, or if an early scan is concerning, patients should have a diagnostic ultrasound and amniocentesis, with referral to specialty care.
In the case of confirmed maternal exposure but normal early ultrasound, serial scans are indicated every month until delivery.
As a federal employee, Dr. Jamieson has no financial disclosures.
WASHINGTON – The Centers for Disease Control and Prevention is recommending blood or urine testing for all pregnant women with possible Zika exposure through travel or because they live in an endemic area, regardless of whether they are symptomatic, Dr. Denise J. Jamieson said at the annual meeting of the American College of Obstetricians and Gynecologists.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Couples interested in conceiving who live in or have traveled to areas of active transmission should be alert for any signs of infection, no matter how slight; if they notice any, they should be tested for exposure before attempting conception, Dr. Jamieson, a medical officer with the CDC’s division of reproductive medicine, said in a video interview.
Unfortunately, she said at an update on the Zika situation, labs that process Zika blood and urine samples are backed up, and test results are being “unacceptably delayed.”
During a discussion period, some physicians in the audience complained of waiting up to 6 weeks for results. One said a local health department official told him that the CDC had a backlog of “a million tests.”
“We do not have a 1-million test backup,” Dr. Jamieson said. “But in some places there are still unacceptably long delays. This is not a test you can just check off on a form and send to a lab.”
Many of the tests are being funneled to the CDC’s Division of Vector-Borne Diseases in Ft. Collins, Colo.; that facility is experiencing a long turnaround time. Other samples are being handled in private labs with CDC contracts, but Dr. Jamieson said there’s an urgent need to expand the testing to many more commercial labs. There is no concrete plan for how or when this expansion will happen, however, she added.
Dr. Jamieson also discussed the CDC’s recommendation for managing pregnant women who have a positive serology or urine. These women should have serial ultrasounds every 3-4 weeks to track fetal brain development. Amniocentesis can positively confirm fetal exposure. A maternal-fetal medicine specialist should be on board if the fetus tests positive or if any concerning signs appear on imaging. Newborns can also be tested for exposure, as can placental and cord tissue.
On May 16, the World Health Organization released a comprehensive document describing a management algorithm for pregnant women who live in or travel to Zika-endemic areas.
Women who haven’t experienced signs and symptoms of an infection can proceed with routine care, and, if possible, an ultrasound before 18 weeks’ gestation and another at 28-30 weeks.
Women who have had signs of an infection should be tested for exposure. If negative, routine care with an early ultrasound and one at 28-30 weeks is indicated. If the results are positive, or if an early scan is concerning, patients should have a diagnostic ultrasound and amniocentesis, with referral to specialty care.
In the case of confirmed maternal exposure but normal early ultrasound, serial scans are indicated every month until delivery.
As a federal employee, Dr. Jamieson has no financial disclosures.
EXPERT ANALYSIS FROM ACOG 2016
Astrovirus MLB2 may cause CNS infection in immunocompromised patients
The astrovirus MLB2, normally prevalent in feces, can spread outside the digestive system and cause central nervous system infection in immunocompromised patients, according to Dr. Samuel Cordey and his associates.
The initial case-patient was a 21-year-old woman who was admitted because of an unusually severe headache and a fever. She was diagnosed with acute meningitis. Next-generation sequencing (NGS) identified 155 reads of astrovirus MLB2 in the patient’s cerebrospinal fluid, 9,340 in an anal swab, 18 in the patient’s plasma, and 16 in the urine. NGS did not identify any other RNA viruses, and no viral or bacterial pathogens were found in DNA sequencing.
In a subsequent pilot study, 943 stool samples from 615 patients and 424 CSF samples from 404 patients were tested for astrovirus MLB2 via reverse transcription PCR. Stool samples were positive for MLB2 in six patients, five of whom were severely immunocompromised. CSF samples were positive for MLB2 in one patient, a recipient of a hematopoietic stem cell transplant.
The study findings “could place astrovirus MLB2 in the differential diagnosis not only of diarrhea but also of aseptic meningitis and protracted infection in highly immunocompromised hosts. Potential determinants of extraintestinal dissemination, such as viral load kinetic, immune response, and host and viral genetic factors, require further characterization,” the investigators said.
Find the study in Emerging Infectious Diseases (doi: 10.3201/eid2205.151807).
The astrovirus MLB2, normally prevalent in feces, can spread outside the digestive system and cause central nervous system infection in immunocompromised patients, according to Dr. Samuel Cordey and his associates.
The initial case-patient was a 21-year-old woman who was admitted because of an unusually severe headache and a fever. She was diagnosed with acute meningitis. Next-generation sequencing (NGS) identified 155 reads of astrovirus MLB2 in the patient’s cerebrospinal fluid, 9,340 in an anal swab, 18 in the patient’s plasma, and 16 in the urine. NGS did not identify any other RNA viruses, and no viral or bacterial pathogens were found in DNA sequencing.
In a subsequent pilot study, 943 stool samples from 615 patients and 424 CSF samples from 404 patients were tested for astrovirus MLB2 via reverse transcription PCR. Stool samples were positive for MLB2 in six patients, five of whom were severely immunocompromised. CSF samples were positive for MLB2 in one patient, a recipient of a hematopoietic stem cell transplant.
The study findings “could place astrovirus MLB2 in the differential diagnosis not only of diarrhea but also of aseptic meningitis and protracted infection in highly immunocompromised hosts. Potential determinants of extraintestinal dissemination, such as viral load kinetic, immune response, and host and viral genetic factors, require further characterization,” the investigators said.
Find the study in Emerging Infectious Diseases (doi: 10.3201/eid2205.151807).
The astrovirus MLB2, normally prevalent in feces, can spread outside the digestive system and cause central nervous system infection in immunocompromised patients, according to Dr. Samuel Cordey and his associates.
The initial case-patient was a 21-year-old woman who was admitted because of an unusually severe headache and a fever. She was diagnosed with acute meningitis. Next-generation sequencing (NGS) identified 155 reads of astrovirus MLB2 in the patient’s cerebrospinal fluid, 9,340 in an anal swab, 18 in the patient’s plasma, and 16 in the urine. NGS did not identify any other RNA viruses, and no viral or bacterial pathogens were found in DNA sequencing.
In a subsequent pilot study, 943 stool samples from 615 patients and 424 CSF samples from 404 patients were tested for astrovirus MLB2 via reverse transcription PCR. Stool samples were positive for MLB2 in six patients, five of whom were severely immunocompromised. CSF samples were positive for MLB2 in one patient, a recipient of a hematopoietic stem cell transplant.
The study findings “could place astrovirus MLB2 in the differential diagnosis not only of diarrhea but also of aseptic meningitis and protracted infection in highly immunocompromised hosts. Potential determinants of extraintestinal dissemination, such as viral load kinetic, immune response, and host and viral genetic factors, require further characterization,” the investigators said.
Find the study in Emerging Infectious Diseases (doi: 10.3201/eid2205.151807).
FROM EMERGING INFECTIOUS DISEASES
CDC: Zika virus urine testing preferable to serum
New data showing that Zika virus can be found at higher levels or for longer duration in urine than serum, has prompted the Centers for Disease Control and Prevention to update its interim diagnostic testing guidance for the virus in public health laboratories.
The CDC now recommends that Zika virus real-time reverse transcription–polymerase chain reaction (rRT-PCR) be performed on urine collected less than 14 days after the onset of symptoms in patients with suspected Zika virus disease. The rRT-PCR is the preferred test for Zika infection because it can be performed rapidly and is highly specific, the CDC notes, and currently, the CDC Trioplex rRT-PCR assay is the only diagnostic tool authorized by the Food and Drug Administration for Zika virus testing of urine (MMWR. 2016 May 10. doi:10.15585/mmwr.mm6518e1).
In most patients, Zika virus RNA is unlikely to be detected in serum after the first week of illness, the CDC said, but adaptations of previously published diagnostic methods suggest that Zika virus RNA can be detected in urine for at least 2 weeks after onset of symptoms. However, the CDC affirmed that Zika virus rRT-PCR testing of urine should be performed in conjunction with serum testing if using specimens collected less than 7 days after symptom onset, and a positive result in either specimen type provides evidence of Zika virus infection.
The CDC added that, because viremia decreases over time and dates of illness onset may not be accurately reported, a negative rRT-PCR does not exclude Zika virus infection, and IgM antibody testing should be performed. The agency also said other laboratory-developed tests will need in-house validations to adequately characterize the performance of the assay and meet Clinical Laboratory Improvement Amendments requirements.
Read the full report here.
On Twitter @richpizzi
New data showing that Zika virus can be found at higher levels or for longer duration in urine than serum, has prompted the Centers for Disease Control and Prevention to update its interim diagnostic testing guidance for the virus in public health laboratories.
The CDC now recommends that Zika virus real-time reverse transcription–polymerase chain reaction (rRT-PCR) be performed on urine collected less than 14 days after the onset of symptoms in patients with suspected Zika virus disease. The rRT-PCR is the preferred test for Zika infection because it can be performed rapidly and is highly specific, the CDC notes, and currently, the CDC Trioplex rRT-PCR assay is the only diagnostic tool authorized by the Food and Drug Administration for Zika virus testing of urine (MMWR. 2016 May 10. doi:10.15585/mmwr.mm6518e1).
In most patients, Zika virus RNA is unlikely to be detected in serum after the first week of illness, the CDC said, but adaptations of previously published diagnostic methods suggest that Zika virus RNA can be detected in urine for at least 2 weeks after onset of symptoms. However, the CDC affirmed that Zika virus rRT-PCR testing of urine should be performed in conjunction with serum testing if using specimens collected less than 7 days after symptom onset, and a positive result in either specimen type provides evidence of Zika virus infection.
The CDC added that, because viremia decreases over time and dates of illness onset may not be accurately reported, a negative rRT-PCR does not exclude Zika virus infection, and IgM antibody testing should be performed. The agency also said other laboratory-developed tests will need in-house validations to adequately characterize the performance of the assay and meet Clinical Laboratory Improvement Amendments requirements.
Read the full report here.
On Twitter @richpizzi
New data showing that Zika virus can be found at higher levels or for longer duration in urine than serum, has prompted the Centers for Disease Control and Prevention to update its interim diagnostic testing guidance for the virus in public health laboratories.
The CDC now recommends that Zika virus real-time reverse transcription–polymerase chain reaction (rRT-PCR) be performed on urine collected less than 14 days after the onset of symptoms in patients with suspected Zika virus disease. The rRT-PCR is the preferred test for Zika infection because it can be performed rapidly and is highly specific, the CDC notes, and currently, the CDC Trioplex rRT-PCR assay is the only diagnostic tool authorized by the Food and Drug Administration for Zika virus testing of urine (MMWR. 2016 May 10. doi:10.15585/mmwr.mm6518e1).
In most patients, Zika virus RNA is unlikely to be detected in serum after the first week of illness, the CDC said, but adaptations of previously published diagnostic methods suggest that Zika virus RNA can be detected in urine for at least 2 weeks after onset of symptoms. However, the CDC affirmed that Zika virus rRT-PCR testing of urine should be performed in conjunction with serum testing if using specimens collected less than 7 days after symptom onset, and a positive result in either specimen type provides evidence of Zika virus infection.
The CDC added that, because viremia decreases over time and dates of illness onset may not be accurately reported, a negative rRT-PCR does not exclude Zika virus infection, and IgM antibody testing should be performed. The agency also said other laboratory-developed tests will need in-house validations to adequately characterize the performance of the assay and meet Clinical Laboratory Improvement Amendments requirements.
Read the full report here.
On Twitter @richpizzi
FROM MORBIDITY AND MORTALITY WEEKLY REPORT
U.S. official raises concerns over Zika readiness
The ability of the United States to respond to a potential spike in Zika virus infection rates is a cause for concern, according to a top federal health official.
“The big question is will we get local transmission, and my response to that is very likely we will,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told reporters during a joint media briefing with the Pan American Health Organization (PAHO) on May 3.
As many as 500 million people in the Americas are at risk for being infected by the Zika virus, PAHO’s Zika incident manager, Dr. Sylvain Aldighieri, said during the briefing.
In the continental United States to date, there have been about 400 travel-related cases of infection. In Puerto Rico, there have been nearly 700 locally reported cases, and one Zika-related death.
Countries at highest risk for Zika include those that have experienced any outbreaks of dengue fever or chikungunya in the past 15 years, Dr. Aldighieri said. Hawaii and U.S. territories in the Caribbean have experienced local dengue outbreaks during that time. Florida has had local outbreaks of both illnesses.
In the United States, Zika is poised to gain a stronger foothold even as funding for the study and prevention of the virus remains stalled in Congress, and a lack of cohesive public health messaging leaves the public vulnerable to misunderstanding the potential threat of the disease, according to Dr. Fauci.
A vaccine to fight Zika virus is currently under development. “Don’t confuse that with readiness,” Dr. Fauci cautioned.
Dr. Fauci said he believes the disbursement by Congress of President Obama’s requested $1.9 billion in Zika-related funds would facilitate a more comprehensive approach to preventing and treating the virus’s spread, but so far, the funding remains stalled.
As a result, Dr. Fauci said he has reallocated funds intended for other infectious disease research needs to cover Zika-related costs, but is concerned that continued congressional inaction could mean he is left with holes across many budgets. “That 1.9 billion dollars is essential,” he said.
Vaccine progress
In April, $589 millionin funds primarily earmarked for the Ebola crisis were redirected by the Obama administration to fight the Zika virus. That money is now being used in part to fund development of a vaccine that is expected to be ready for a phase I study of 80 people by September 2016. If successful, a phase II-b efficacy study of the vaccine would be conducted in the first quarter of 2017 in a country or region that has a high rate of infection.
Dr. Fauci said that although the study is not be as high-powered as would be ideal, researchers might be able to determine the vaccine’s efficacy with several thousand volunteers, taking into consideration that during the 1-3 years needed to gather conclusive data, herd immunity could skew rates of infection downward, bringing into question the vaccine’s actual efficacy.
“That’s just something we have to deal with,” Dr. Fauci said, saying that fewer people being infected is a good thing, either way.
Research gaps
Other pressing Zika research needs to include learning more about the virus’s impact on a developing fetus.
“We don’t know exactly what the percentage is of [infants born with] microcephaly,” Dr. Fauci said. “We don’t know beyond microcephaly what the long-range effects are on babies that look like they were born [without microcephaly] but might have other defects that are more subtle.”
Dr. Fauci said current data are unhelpful in that they show anywhere from 1% to 29% of infected mothers will give birth to children with congenital defects. However, he said that a coalition of nations affected by the virus is currently enrolling thousands of pregnant women in a cohort study to determine risk ratios.
“When we get the data from that study, we will be able to answer precisely what the percentage is, but today in May 2016, we don’t know the answer,” he said.
Predicting which infants are most susceptible, and at what point in utero abnormalities develop, are questions still under investigation, although a study published earlier this year supports the theory that infection during the first trimester poses the highest risk to a developing fetus.
Communicating risk
Another problem facing health officials is how to communicate the potential seriousness of an illness that, if it presents at all, does so only mildly, Dr. Fauci said. “In general, it’s a disease in which 80% of people don’t have any symptoms.”
The World Health Organization advises physicians to suspect Zika – particularly if a person has been in Zika-affected regions – if clinical symptoms include rash, fever, or both, plus at least one of these: arthralgia, arthritis, or conjunctivitis. Aside from bed rest, hydration, and over-the-counter analgesics, there are no specific treatments for the virus.
How to counsel women about avoiding pregnancy where Zika is a concern also poses challenges, particularly if the pregnancy is unintended, as about half of all American pregnancies are, or if, as Dr. Fauci told reporters, pregnancy is “guided by laws and religion.”
Although federal policy has not been to advise persons about whether to delay pregnancy, Dr. Fauci said U.S. officials are unwilling to contradict authorities in local regions such as Puerto Rico where such statements have been issued.
On April 28, the Food and Drug Administration authorized the emergency use of a commercial in vitro diagnostic test for use in individuals with symptoms of the virus, or those who have traveled to affected regions. Earlier this year, the FDA granted emergency authorization for use of a single test that can detect Zika, dengue, and chikungunya. Still, serology tests for Zika are often inconclusive, since the virus can mimic dengue or chikungunya, according to Dr. Aldighieri. “It can be complex to know if there is a Zika or dengue or chikungunya outbreak,” he said.
On Twitter @whitneymcknight
The ability of the United States to respond to a potential spike in Zika virus infection rates is a cause for concern, according to a top federal health official.
“The big question is will we get local transmission, and my response to that is very likely we will,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told reporters during a joint media briefing with the Pan American Health Organization (PAHO) on May 3.
As many as 500 million people in the Americas are at risk for being infected by the Zika virus, PAHO’s Zika incident manager, Dr. Sylvain Aldighieri, said during the briefing.
In the continental United States to date, there have been about 400 travel-related cases of infection. In Puerto Rico, there have been nearly 700 locally reported cases, and one Zika-related death.
Countries at highest risk for Zika include those that have experienced any outbreaks of dengue fever or chikungunya in the past 15 years, Dr. Aldighieri said. Hawaii and U.S. territories in the Caribbean have experienced local dengue outbreaks during that time. Florida has had local outbreaks of both illnesses.
In the United States, Zika is poised to gain a stronger foothold even as funding for the study and prevention of the virus remains stalled in Congress, and a lack of cohesive public health messaging leaves the public vulnerable to misunderstanding the potential threat of the disease, according to Dr. Fauci.
A vaccine to fight Zika virus is currently under development. “Don’t confuse that with readiness,” Dr. Fauci cautioned.
Dr. Fauci said he believes the disbursement by Congress of President Obama’s requested $1.9 billion in Zika-related funds would facilitate a more comprehensive approach to preventing and treating the virus’s spread, but so far, the funding remains stalled.
As a result, Dr. Fauci said he has reallocated funds intended for other infectious disease research needs to cover Zika-related costs, but is concerned that continued congressional inaction could mean he is left with holes across many budgets. “That 1.9 billion dollars is essential,” he said.
Vaccine progress
In April, $589 millionin funds primarily earmarked for the Ebola crisis were redirected by the Obama administration to fight the Zika virus. That money is now being used in part to fund development of a vaccine that is expected to be ready for a phase I study of 80 people by September 2016. If successful, a phase II-b efficacy study of the vaccine would be conducted in the first quarter of 2017 in a country or region that has a high rate of infection.
Dr. Fauci said that although the study is not be as high-powered as would be ideal, researchers might be able to determine the vaccine’s efficacy with several thousand volunteers, taking into consideration that during the 1-3 years needed to gather conclusive data, herd immunity could skew rates of infection downward, bringing into question the vaccine’s actual efficacy.
“That’s just something we have to deal with,” Dr. Fauci said, saying that fewer people being infected is a good thing, either way.
Research gaps
Other pressing Zika research needs to include learning more about the virus’s impact on a developing fetus.
“We don’t know exactly what the percentage is of [infants born with] microcephaly,” Dr. Fauci said. “We don’t know beyond microcephaly what the long-range effects are on babies that look like they were born [without microcephaly] but might have other defects that are more subtle.”
Dr. Fauci said current data are unhelpful in that they show anywhere from 1% to 29% of infected mothers will give birth to children with congenital defects. However, he said that a coalition of nations affected by the virus is currently enrolling thousands of pregnant women in a cohort study to determine risk ratios.
“When we get the data from that study, we will be able to answer precisely what the percentage is, but today in May 2016, we don’t know the answer,” he said.
Predicting which infants are most susceptible, and at what point in utero abnormalities develop, are questions still under investigation, although a study published earlier this year supports the theory that infection during the first trimester poses the highest risk to a developing fetus.
Communicating risk
Another problem facing health officials is how to communicate the potential seriousness of an illness that, if it presents at all, does so only mildly, Dr. Fauci said. “In general, it’s a disease in which 80% of people don’t have any symptoms.”
The World Health Organization advises physicians to suspect Zika – particularly if a person has been in Zika-affected regions – if clinical symptoms include rash, fever, or both, plus at least one of these: arthralgia, arthritis, or conjunctivitis. Aside from bed rest, hydration, and over-the-counter analgesics, there are no specific treatments for the virus.
How to counsel women about avoiding pregnancy where Zika is a concern also poses challenges, particularly if the pregnancy is unintended, as about half of all American pregnancies are, or if, as Dr. Fauci told reporters, pregnancy is “guided by laws and religion.”
Although federal policy has not been to advise persons about whether to delay pregnancy, Dr. Fauci said U.S. officials are unwilling to contradict authorities in local regions such as Puerto Rico where such statements have been issued.
On April 28, the Food and Drug Administration authorized the emergency use of a commercial in vitro diagnostic test for use in individuals with symptoms of the virus, or those who have traveled to affected regions. Earlier this year, the FDA granted emergency authorization for use of a single test that can detect Zika, dengue, and chikungunya. Still, serology tests for Zika are often inconclusive, since the virus can mimic dengue or chikungunya, according to Dr. Aldighieri. “It can be complex to know if there is a Zika or dengue or chikungunya outbreak,” he said.
On Twitter @whitneymcknight
The ability of the United States to respond to a potential spike in Zika virus infection rates is a cause for concern, according to a top federal health official.
“The big question is will we get local transmission, and my response to that is very likely we will,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told reporters during a joint media briefing with the Pan American Health Organization (PAHO) on May 3.
As many as 500 million people in the Americas are at risk for being infected by the Zika virus, PAHO’s Zika incident manager, Dr. Sylvain Aldighieri, said during the briefing.
In the continental United States to date, there have been about 400 travel-related cases of infection. In Puerto Rico, there have been nearly 700 locally reported cases, and one Zika-related death.
Countries at highest risk for Zika include those that have experienced any outbreaks of dengue fever or chikungunya in the past 15 years, Dr. Aldighieri said. Hawaii and U.S. territories in the Caribbean have experienced local dengue outbreaks during that time. Florida has had local outbreaks of both illnesses.
In the United States, Zika is poised to gain a stronger foothold even as funding for the study and prevention of the virus remains stalled in Congress, and a lack of cohesive public health messaging leaves the public vulnerable to misunderstanding the potential threat of the disease, according to Dr. Fauci.
A vaccine to fight Zika virus is currently under development. “Don’t confuse that with readiness,” Dr. Fauci cautioned.
Dr. Fauci said he believes the disbursement by Congress of President Obama’s requested $1.9 billion in Zika-related funds would facilitate a more comprehensive approach to preventing and treating the virus’s spread, but so far, the funding remains stalled.
As a result, Dr. Fauci said he has reallocated funds intended for other infectious disease research needs to cover Zika-related costs, but is concerned that continued congressional inaction could mean he is left with holes across many budgets. “That 1.9 billion dollars is essential,” he said.
Vaccine progress
In April, $589 millionin funds primarily earmarked for the Ebola crisis were redirected by the Obama administration to fight the Zika virus. That money is now being used in part to fund development of a vaccine that is expected to be ready for a phase I study of 80 people by September 2016. If successful, a phase II-b efficacy study of the vaccine would be conducted in the first quarter of 2017 in a country or region that has a high rate of infection.
Dr. Fauci said that although the study is not be as high-powered as would be ideal, researchers might be able to determine the vaccine’s efficacy with several thousand volunteers, taking into consideration that during the 1-3 years needed to gather conclusive data, herd immunity could skew rates of infection downward, bringing into question the vaccine’s actual efficacy.
“That’s just something we have to deal with,” Dr. Fauci said, saying that fewer people being infected is a good thing, either way.
Research gaps
Other pressing Zika research needs to include learning more about the virus’s impact on a developing fetus.
“We don’t know exactly what the percentage is of [infants born with] microcephaly,” Dr. Fauci said. “We don’t know beyond microcephaly what the long-range effects are on babies that look like they were born [without microcephaly] but might have other defects that are more subtle.”
Dr. Fauci said current data are unhelpful in that they show anywhere from 1% to 29% of infected mothers will give birth to children with congenital defects. However, he said that a coalition of nations affected by the virus is currently enrolling thousands of pregnant women in a cohort study to determine risk ratios.
“When we get the data from that study, we will be able to answer precisely what the percentage is, but today in May 2016, we don’t know the answer,” he said.
Predicting which infants are most susceptible, and at what point in utero abnormalities develop, are questions still under investigation, although a study published earlier this year supports the theory that infection during the first trimester poses the highest risk to a developing fetus.
Communicating risk
Another problem facing health officials is how to communicate the potential seriousness of an illness that, if it presents at all, does so only mildly, Dr. Fauci said. “In general, it’s a disease in which 80% of people don’t have any symptoms.”
The World Health Organization advises physicians to suspect Zika – particularly if a person has been in Zika-affected regions – if clinical symptoms include rash, fever, or both, plus at least one of these: arthralgia, arthritis, or conjunctivitis. Aside from bed rest, hydration, and over-the-counter analgesics, there are no specific treatments for the virus.
How to counsel women about avoiding pregnancy where Zika is a concern also poses challenges, particularly if the pregnancy is unintended, as about half of all American pregnancies are, or if, as Dr. Fauci told reporters, pregnancy is “guided by laws and religion.”
Although federal policy has not been to advise persons about whether to delay pregnancy, Dr. Fauci said U.S. officials are unwilling to contradict authorities in local regions such as Puerto Rico where such statements have been issued.
On April 28, the Food and Drug Administration authorized the emergency use of a commercial in vitro diagnostic test for use in individuals with symptoms of the virus, or those who have traveled to affected regions. Earlier this year, the FDA granted emergency authorization for use of a single test that can detect Zika, dengue, and chikungunya. Still, serology tests for Zika are often inconclusive, since the virus can mimic dengue or chikungunya, according to Dr. Aldighieri. “It can be complex to know if there is a Zika or dengue or chikungunya outbreak,” he said.
On Twitter @whitneymcknight
CDC reports hundreds of Zika virus cases in Puerto Rico
Since the beginning of the Zika virus outbreak in November 2015, Puerto Rico has had 683 cases of virus that have been laboratory-confirmed or presumed positive, according to new data from the Centers for Disease Control and Prevention.
Of the 683 Zika virus cases, 64% were found in women, with 65 cases occurring in pregnant women. The median age of patients was 34 years old. The most common symptoms were rash, myalgia, headache, fever, and arthralgia, all seen in more than 60% of patients. Hospitalization was required for 17 patients, and 1 death occurred due to complications from a severe thrombocytopenia. The data covers the time period of Nov. 1, 2015 to April 14, 2016.
Cases of Zika virus were negligible until the final week of November 2015, and rose slowly until spiking dramatically at the beginning of February 2016. Since early February, incidence of Zika has not fallen below 40 cases a week. Between Nov. 1, 2015 and April 14, 2016, there have been 110 cases of dengue and 61 cases of chikungunya reported, and neither had an incidence greater than 25 cases a week.
“Although Zika virus–associated deaths are rare, the first identified death in Puerto Rico highlights the possibility of severe cases, as well as the need for continued outreach to raise health care providers’ awareness of complications that might lead to severe disease or death,” the CDC investigators wrote. “To ensure continued blood safety, blood collection resumed with a donor screening program for Zika virus infection, and all units screened positive are removed.”
Find the full report in the CDC’s Morbidity and Mortality Weekly Report (doi: 10.15585/mmwr.mm6517e2)
Since the beginning of the Zika virus outbreak in November 2015, Puerto Rico has had 683 cases of virus that have been laboratory-confirmed or presumed positive, according to new data from the Centers for Disease Control and Prevention.
Of the 683 Zika virus cases, 64% were found in women, with 65 cases occurring in pregnant women. The median age of patients was 34 years old. The most common symptoms were rash, myalgia, headache, fever, and arthralgia, all seen in more than 60% of patients. Hospitalization was required for 17 patients, and 1 death occurred due to complications from a severe thrombocytopenia. The data covers the time period of Nov. 1, 2015 to April 14, 2016.
Cases of Zika virus were negligible until the final week of November 2015, and rose slowly until spiking dramatically at the beginning of February 2016. Since early February, incidence of Zika has not fallen below 40 cases a week. Between Nov. 1, 2015 and April 14, 2016, there have been 110 cases of dengue and 61 cases of chikungunya reported, and neither had an incidence greater than 25 cases a week.
“Although Zika virus–associated deaths are rare, the first identified death in Puerto Rico highlights the possibility of severe cases, as well as the need for continued outreach to raise health care providers’ awareness of complications that might lead to severe disease or death,” the CDC investigators wrote. “To ensure continued blood safety, blood collection resumed with a donor screening program for Zika virus infection, and all units screened positive are removed.”
Find the full report in the CDC’s Morbidity and Mortality Weekly Report (doi: 10.15585/mmwr.mm6517e2)
Since the beginning of the Zika virus outbreak in November 2015, Puerto Rico has had 683 cases of virus that have been laboratory-confirmed or presumed positive, according to new data from the Centers for Disease Control and Prevention.
Of the 683 Zika virus cases, 64% were found in women, with 65 cases occurring in pregnant women. The median age of patients was 34 years old. The most common symptoms were rash, myalgia, headache, fever, and arthralgia, all seen in more than 60% of patients. Hospitalization was required for 17 patients, and 1 death occurred due to complications from a severe thrombocytopenia. The data covers the time period of Nov. 1, 2015 to April 14, 2016.
Cases of Zika virus were negligible until the final week of November 2015, and rose slowly until spiking dramatically at the beginning of February 2016. Since early February, incidence of Zika has not fallen below 40 cases a week. Between Nov. 1, 2015 and April 14, 2016, there have been 110 cases of dengue and 61 cases of chikungunya reported, and neither had an incidence greater than 25 cases a week.
“Although Zika virus–associated deaths are rare, the first identified death in Puerto Rico highlights the possibility of severe cases, as well as the need for continued outreach to raise health care providers’ awareness of complications that might lead to severe disease or death,” the CDC investigators wrote. “To ensure continued blood safety, blood collection resumed with a donor screening program for Zika virus infection, and all units screened positive are removed.”
Find the full report in the CDC’s Morbidity and Mortality Weekly Report (doi: 10.15585/mmwr.mm6517e2)
FROM MMWR
Two Ebola vaccines effective, safe in phase I trials
Two Ebola vaccines were found safe and effective in separate international phase I trials involving healthy European and African adults, according to two reports published online April 27 in the New England Journal of Medicine.
After further testing and confirmation of these preliminary results, both vaccines should prove useful in both preventing and controlling future outbreaks, both research groups said.
Several vaccines showed promise in previous primate and preliminary human studies, including one expressing the surface glycoprotein of Zaire ebolavirus (ZEBOV). Different versions of this vaccine were assessed in the present phase I studies.
In the first trial, investigators sought to extend the durability of this vaccine by administering a single “priming” dose of the chimpanzee adenovirus 3 (ChAd3) vaccine encoding the ZEBOV surface glycoprotein, then giving a “booster” with a modified vaccinia Ankara (MVA) strain either 1 or 2 weeks later. The participants, 60 healthy adults aged 18-50 years, were randomly assigned to receive a low dose (20 subjects), an intermediate dose (20 subjects), or a high dose (20 subjects) of viral particles. Ten participants from each of these dose groups were then offered the booster. Then two additional groups of eight participants each were assessed to see whether giving the booster at 1 week vs. at 2 weeks made a difference in immunogenicity or safety.
All the study groups showed both antibody and T-cell immunogenicity after vaccination, but the groups that received the boosters showed antibody responses four times higher than those who did not. The MVA booster increased virus-specific antibodies by a factor of 12, and significantly increased neutralizing antibodies as well, said Dr. Katie Ewer of the Jenner Institute and Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford (England) and the National Institute for Health Research Oxford Biomedical Research Centre and her associates.
The boosters also improved the vaccine’s cell-mediated immunity, increasing glycoprotein-specific CD8+ T cells by a factor of five.
In addition, the MVA booster markedly improved the vaccine’s durability, with 100% of recipients continuing to show seropositivity at 6 months, compared with only 50%-74% of participants who did not receive the booster.
The safety profile of the vaccine and the booster were termed “acceptable” at all dose levels and at all dosing intervals studied. There were no serious adverse events, and most adverse events were self-limited and mild. Moderate systemic adverse events included transient fever, myalgia, arthralgia, headache, fatigue, nausea, and malaise. Regarding laboratory abnormalities, four patients showed prolonged activated partial-thromboplastin time without coagulopathy, all of which resolved within 10 weeks; several patients showed mild or moderate lymphocytopenia and mild or moderate elevations in bilirubin, all of which were transient.
Overall, “We found that boosting can be immunogenic for antibodies and T cells at prime-boost intervals as short as 1 week. Such short-interval regimens may facilitate vaccine deployment in outbreak settings where both rapid onset and durable vaccine efficacy are required,” Dr. Ewer and her associates noted (N Engl J Med. 2016 Apr 27. doi: 10.1056/NEJMoa1411627).
They added that the ChAd3-plus-MVA viral vectors have other practical advantages. “Large-scale manufacturing processes concordant with Good Manufacturing Practice standards have been established, and both vectors have been assessed in large numbers of vaccines for a range of indications, without reports of any substantial safety concerns to date,” Dr. Ewer and her coauthors said.
The second report concerned four parallel studies: three open-label dose-escalation studies in Gabon, Kenya, and Germany and one randomized, double-blind trial in Geneva assessing the safety and immunogenicity of several doses of recombinant vesicular stomatitis virus (rVSV)-vectored ZEBOV. The 158 participants were followed for at least 6 months, said Dr. Selidji T. Agnandji of the Centre de Recherches Medicales de Lambarene (Gabon), the Institut für Tropenmedizin, Universitätsklinikum Tübingen (Germany), and the German Center for Infection Research, Tübingen, and his associates.
The vaccine was immunogenic in all participants across every dose and every study site, with higher glycoprotein-binding antibody titers at higher doses. These antibodies persisted through 6 months, a “promising” result suggesting that a single dose of this vaccine may be sufficient for early and possibly for long-term protection, the investigators said (N Engl J Med. 2016 Apr 27. doi: 10.1056/NEJMoa1502924).
Although there were no serious adverse events associated with this vaccine, acute vaccine reactions were common: 92% of patients reported an acute reaction, and 10%-22% (depending on the study site) reported grade 3 symptoms. The most bothersome – and unexpected – reactions involved viral seeding of joints and skin.
The joint problems manifested as arthritis, tenosynovitis, or bursitis that appeared at a median of 11 days after injection. The arthritis tended to affect one to four peripheral joints asymmetrically; pain was usually mild and dysfunction was usually moderate. Ten of the 11 affected patients in Geneva and both of the two (out of 60) affected patients at the other sites were symptom-free by 6 months. These findings “suggest a favorable long-term prognosis for these vaccine-induced arthritides,” Dr. Agnandji and his associates said.
Three participants developed maculopapular rashes mainly affecting the limbs, which appeared at 7-9 days following injection and persisted for 1-2 weeks. The rash was accompanied by a few tender vesicles on fingers or toes. Synovial fluid extracted from affected joints and material recovered from skin vesicles showed the presence of rVSV.
Given that most adverse reactions occurred soon after vaccination, were of short duration, and were amenable to treatment, this vaccine demonstrated “a favorable risk-benefit balance,” they added.
Two Ebola vaccines were found safe and effective in separate international phase I trials involving healthy European and African adults, according to two reports published online April 27 in the New England Journal of Medicine.
After further testing and confirmation of these preliminary results, both vaccines should prove useful in both preventing and controlling future outbreaks, both research groups said.
Several vaccines showed promise in previous primate and preliminary human studies, including one expressing the surface glycoprotein of Zaire ebolavirus (ZEBOV). Different versions of this vaccine were assessed in the present phase I studies.
In the first trial, investigators sought to extend the durability of this vaccine by administering a single “priming” dose of the chimpanzee adenovirus 3 (ChAd3) vaccine encoding the ZEBOV surface glycoprotein, then giving a “booster” with a modified vaccinia Ankara (MVA) strain either 1 or 2 weeks later. The participants, 60 healthy adults aged 18-50 years, were randomly assigned to receive a low dose (20 subjects), an intermediate dose (20 subjects), or a high dose (20 subjects) of viral particles. Ten participants from each of these dose groups were then offered the booster. Then two additional groups of eight participants each were assessed to see whether giving the booster at 1 week vs. at 2 weeks made a difference in immunogenicity or safety.
All the study groups showed both antibody and T-cell immunogenicity after vaccination, but the groups that received the boosters showed antibody responses four times higher than those who did not. The MVA booster increased virus-specific antibodies by a factor of 12, and significantly increased neutralizing antibodies as well, said Dr. Katie Ewer of the Jenner Institute and Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford (England) and the National Institute for Health Research Oxford Biomedical Research Centre and her associates.
The boosters also improved the vaccine’s cell-mediated immunity, increasing glycoprotein-specific CD8+ T cells by a factor of five.
In addition, the MVA booster markedly improved the vaccine’s durability, with 100% of recipients continuing to show seropositivity at 6 months, compared with only 50%-74% of participants who did not receive the booster.
The safety profile of the vaccine and the booster were termed “acceptable” at all dose levels and at all dosing intervals studied. There were no serious adverse events, and most adverse events were self-limited and mild. Moderate systemic adverse events included transient fever, myalgia, arthralgia, headache, fatigue, nausea, and malaise. Regarding laboratory abnormalities, four patients showed prolonged activated partial-thromboplastin time without coagulopathy, all of which resolved within 10 weeks; several patients showed mild or moderate lymphocytopenia and mild or moderate elevations in bilirubin, all of which were transient.
Overall, “We found that boosting can be immunogenic for antibodies and T cells at prime-boost intervals as short as 1 week. Such short-interval regimens may facilitate vaccine deployment in outbreak settings where both rapid onset and durable vaccine efficacy are required,” Dr. Ewer and her associates noted (N Engl J Med. 2016 Apr 27. doi: 10.1056/NEJMoa1411627).
They added that the ChAd3-plus-MVA viral vectors have other practical advantages. “Large-scale manufacturing processes concordant with Good Manufacturing Practice standards have been established, and both vectors have been assessed in large numbers of vaccines for a range of indications, without reports of any substantial safety concerns to date,” Dr. Ewer and her coauthors said.
The second report concerned four parallel studies: three open-label dose-escalation studies in Gabon, Kenya, and Germany and one randomized, double-blind trial in Geneva assessing the safety and immunogenicity of several doses of recombinant vesicular stomatitis virus (rVSV)-vectored ZEBOV. The 158 participants were followed for at least 6 months, said Dr. Selidji T. Agnandji of the Centre de Recherches Medicales de Lambarene (Gabon), the Institut für Tropenmedizin, Universitätsklinikum Tübingen (Germany), and the German Center for Infection Research, Tübingen, and his associates.
The vaccine was immunogenic in all participants across every dose and every study site, with higher glycoprotein-binding antibody titers at higher doses. These antibodies persisted through 6 months, a “promising” result suggesting that a single dose of this vaccine may be sufficient for early and possibly for long-term protection, the investigators said (N Engl J Med. 2016 Apr 27. doi: 10.1056/NEJMoa1502924).
Although there were no serious adverse events associated with this vaccine, acute vaccine reactions were common: 92% of patients reported an acute reaction, and 10%-22% (depending on the study site) reported grade 3 symptoms. The most bothersome – and unexpected – reactions involved viral seeding of joints and skin.
The joint problems manifested as arthritis, tenosynovitis, or bursitis that appeared at a median of 11 days after injection. The arthritis tended to affect one to four peripheral joints asymmetrically; pain was usually mild and dysfunction was usually moderate. Ten of the 11 affected patients in Geneva and both of the two (out of 60) affected patients at the other sites were symptom-free by 6 months. These findings “suggest a favorable long-term prognosis for these vaccine-induced arthritides,” Dr. Agnandji and his associates said.
Three participants developed maculopapular rashes mainly affecting the limbs, which appeared at 7-9 days following injection and persisted for 1-2 weeks. The rash was accompanied by a few tender vesicles on fingers or toes. Synovial fluid extracted from affected joints and material recovered from skin vesicles showed the presence of rVSV.
Given that most adverse reactions occurred soon after vaccination, were of short duration, and were amenable to treatment, this vaccine demonstrated “a favorable risk-benefit balance,” they added.
Two Ebola vaccines were found safe and effective in separate international phase I trials involving healthy European and African adults, according to two reports published online April 27 in the New England Journal of Medicine.
After further testing and confirmation of these preliminary results, both vaccines should prove useful in both preventing and controlling future outbreaks, both research groups said.
Several vaccines showed promise in previous primate and preliminary human studies, including one expressing the surface glycoprotein of Zaire ebolavirus (ZEBOV). Different versions of this vaccine were assessed in the present phase I studies.
In the first trial, investigators sought to extend the durability of this vaccine by administering a single “priming” dose of the chimpanzee adenovirus 3 (ChAd3) vaccine encoding the ZEBOV surface glycoprotein, then giving a “booster” with a modified vaccinia Ankara (MVA) strain either 1 or 2 weeks later. The participants, 60 healthy adults aged 18-50 years, were randomly assigned to receive a low dose (20 subjects), an intermediate dose (20 subjects), or a high dose (20 subjects) of viral particles. Ten participants from each of these dose groups were then offered the booster. Then two additional groups of eight participants each were assessed to see whether giving the booster at 1 week vs. at 2 weeks made a difference in immunogenicity or safety.
All the study groups showed both antibody and T-cell immunogenicity after vaccination, but the groups that received the boosters showed antibody responses four times higher than those who did not. The MVA booster increased virus-specific antibodies by a factor of 12, and significantly increased neutralizing antibodies as well, said Dr. Katie Ewer of the Jenner Institute and Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford (England) and the National Institute for Health Research Oxford Biomedical Research Centre and her associates.
The boosters also improved the vaccine’s cell-mediated immunity, increasing glycoprotein-specific CD8+ T cells by a factor of five.
In addition, the MVA booster markedly improved the vaccine’s durability, with 100% of recipients continuing to show seropositivity at 6 months, compared with only 50%-74% of participants who did not receive the booster.
The safety profile of the vaccine and the booster were termed “acceptable” at all dose levels and at all dosing intervals studied. There were no serious adverse events, and most adverse events were self-limited and mild. Moderate systemic adverse events included transient fever, myalgia, arthralgia, headache, fatigue, nausea, and malaise. Regarding laboratory abnormalities, four patients showed prolonged activated partial-thromboplastin time without coagulopathy, all of which resolved within 10 weeks; several patients showed mild or moderate lymphocytopenia and mild or moderate elevations in bilirubin, all of which were transient.
Overall, “We found that boosting can be immunogenic for antibodies and T cells at prime-boost intervals as short as 1 week. Such short-interval regimens may facilitate vaccine deployment in outbreak settings where both rapid onset and durable vaccine efficacy are required,” Dr. Ewer and her associates noted (N Engl J Med. 2016 Apr 27. doi: 10.1056/NEJMoa1411627).
They added that the ChAd3-plus-MVA viral vectors have other practical advantages. “Large-scale manufacturing processes concordant with Good Manufacturing Practice standards have been established, and both vectors have been assessed in large numbers of vaccines for a range of indications, without reports of any substantial safety concerns to date,” Dr. Ewer and her coauthors said.
The second report concerned four parallel studies: three open-label dose-escalation studies in Gabon, Kenya, and Germany and one randomized, double-blind trial in Geneva assessing the safety and immunogenicity of several doses of recombinant vesicular stomatitis virus (rVSV)-vectored ZEBOV. The 158 participants were followed for at least 6 months, said Dr. Selidji T. Agnandji of the Centre de Recherches Medicales de Lambarene (Gabon), the Institut für Tropenmedizin, Universitätsklinikum Tübingen (Germany), and the German Center for Infection Research, Tübingen, and his associates.
The vaccine was immunogenic in all participants across every dose and every study site, with higher glycoprotein-binding antibody titers at higher doses. These antibodies persisted through 6 months, a “promising” result suggesting that a single dose of this vaccine may be sufficient for early and possibly for long-term protection, the investigators said (N Engl J Med. 2016 Apr 27. doi: 10.1056/NEJMoa1502924).
Although there were no serious adverse events associated with this vaccine, acute vaccine reactions were common: 92% of patients reported an acute reaction, and 10%-22% (depending on the study site) reported grade 3 symptoms. The most bothersome – and unexpected – reactions involved viral seeding of joints and skin.
The joint problems manifested as arthritis, tenosynovitis, or bursitis that appeared at a median of 11 days after injection. The arthritis tended to affect one to four peripheral joints asymmetrically; pain was usually mild and dysfunction was usually moderate. Ten of the 11 affected patients in Geneva and both of the two (out of 60) affected patients at the other sites were symptom-free by 6 months. These findings “suggest a favorable long-term prognosis for these vaccine-induced arthritides,” Dr. Agnandji and his associates said.
Three participants developed maculopapular rashes mainly affecting the limbs, which appeared at 7-9 days following injection and persisted for 1-2 weeks. The rash was accompanied by a few tender vesicles on fingers or toes. Synovial fluid extracted from affected joints and material recovered from skin vesicles showed the presence of rVSV.
Given that most adverse reactions occurred soon after vaccination, were of short duration, and were amenable to treatment, this vaccine demonstrated “a favorable risk-benefit balance,” they added.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Two Ebola vaccines were found effective and safe in separate international phase I trials.
Major finding: The ChAd3 vaccine boosted with MVA elicited B-cell and T-cell immune responses to ZEBOV that were superior to those induced by the ChAd3 vaccine alone. The rVSV-ZEBOV vaccine was reactogenic but immunogenic after a single dose.
Data source: A single dose of the chimpanzee adenovirus 3 (ChAd3) vaccine encoding the surface glycoprotein of Zaire ebolavirus (ZEBOV) was given to 60 healthy adult volunteers in Oxford, England. Three open-label, dose-escalation phase I trials and one randomized, double-blind, controlled phase I trial to assess the safety, side-effect profile, and immunogenicity of rVSV-ZEBOV at various doses in 158 healthy adults in Europe and Africa.
Disclosures: Dr. Ewer’s study was supported by the Wellcome Trust, the U. K. Medical Research Council, the U. K. Department for International Development, the U. K. National Institute for Health Research Oxford Biomedical Research Centre, the National Health Service Blood and Transplant, and Public Health England. The ChAd3 vaccine was provided by the U.S. Vaccine Research Center of the National Institute of Allergy and Infectious Diseases and GlaxoSmithKline, and the MVA vaccine booster was provided by the NIAID and Fisher BioServices. Dr. Ewer reported having no relevant financial disclosures; some of her associates reported ties to GlaxoSmithKline and patents pending related to these and other vaccines. Dr. Agnandji’s study was supported by the Wellcome Trust, the German Center for Infection Research, the German National Department for Education and Research, the German Ministry of Health, the Bill and Melinda Gates Foundation, Universitätsklinikum Tübingen, the Austrian Federal Ministry of Science, Research, and Economy, and the U.S. Army Medical Research Institute of Infectious Diseases. The rVSV-ZEBOV vaccine used in this study was donated by the Public Health Agency of Canada and the World Health Organization. Dr. Agnandji reported having no relevant financial disclosures; his associates reported ties to Gilead, GlaxoSmithKline, Merck Sharp & Dohme, Sanaria, and Bristol-Myers Squibb.
CDC issues guidance on worker precautions against Zika virus
As the Zika virus continues to spread, officials at the Occupational Safety and Health Administration (OSHA) and the Centers for Disease Control and Prevention have created a list of precautions to help outdoor workers, healthcare and laboratory personnel, and mosquito control workers avoid infection.
For outdoor workers, the prevention strategies center around using insect repellents, wearing clothing that provides a barrier against mosquitoes, and removing sources of standing water. For people working in healthcare settings and laboratories, OSHA and the CDC urge following good infection control and biosafety practices, including universal precautions to minimize the transmission of Zika virus, and when appropriate to wear gloves, gowns, masks, and eye protection.
Outdoor workers could be at the highest risk of catching the Zika virus, according to the guidance document.
Taking precautions to avoid mosquito bites is especially important when traveling to a Zika-affected area. OSHA and CDC also advised that workers should consider delaying travel if they may become pregnant, or have sexual partners who may become pregnant. The CDC recommends that pregnant women in any trimester avoid travel to an area with active Zika virus transmission.
“Even if they do not feel sick, travelers returning to the United States from an area with Zika should take steps to prevent mosquito bites for three weeks so they do not pass Zika to mosquitoes that could spread the virus to other people,” according to the guidance.
To find more information, click here.
As the Zika virus continues to spread, officials at the Occupational Safety and Health Administration (OSHA) and the Centers for Disease Control and Prevention have created a list of precautions to help outdoor workers, healthcare and laboratory personnel, and mosquito control workers avoid infection.
For outdoor workers, the prevention strategies center around using insect repellents, wearing clothing that provides a barrier against mosquitoes, and removing sources of standing water. For people working in healthcare settings and laboratories, OSHA and the CDC urge following good infection control and biosafety practices, including universal precautions to minimize the transmission of Zika virus, and when appropriate to wear gloves, gowns, masks, and eye protection.
Outdoor workers could be at the highest risk of catching the Zika virus, according to the guidance document.
Taking precautions to avoid mosquito bites is especially important when traveling to a Zika-affected area. OSHA and CDC also advised that workers should consider delaying travel if they may become pregnant, or have sexual partners who may become pregnant. The CDC recommends that pregnant women in any trimester avoid travel to an area with active Zika virus transmission.
“Even if they do not feel sick, travelers returning to the United States from an area with Zika should take steps to prevent mosquito bites for three weeks so they do not pass Zika to mosquitoes that could spread the virus to other people,” according to the guidance.
To find more information, click here.
As the Zika virus continues to spread, officials at the Occupational Safety and Health Administration (OSHA) and the Centers for Disease Control and Prevention have created a list of precautions to help outdoor workers, healthcare and laboratory personnel, and mosquito control workers avoid infection.
For outdoor workers, the prevention strategies center around using insect repellents, wearing clothing that provides a barrier against mosquitoes, and removing sources of standing water. For people working in healthcare settings and laboratories, OSHA and the CDC urge following good infection control and biosafety practices, including universal precautions to minimize the transmission of Zika virus, and when appropriate to wear gloves, gowns, masks, and eye protection.
Outdoor workers could be at the highest risk of catching the Zika virus, according to the guidance document.
Taking precautions to avoid mosquito bites is especially important when traveling to a Zika-affected area. OSHA and CDC also advised that workers should consider delaying travel if they may become pregnant, or have sexual partners who may become pregnant. The CDC recommends that pregnant women in any trimester avoid travel to an area with active Zika virus transmission.
“Even if they do not feel sick, travelers returning to the United States from an area with Zika should take steps to prevent mosquito bites for three weeks so they do not pass Zika to mosquitoes that could spread the virus to other people,” according to the guidance.
To find more information, click here.
CDC: Zika infection unlikely in asymptomatic people, but test pregnant women
Although the likelihood of Zika virus infection is low among asymptomatic patients, the Centers for Disease Control and Prevention recommends offering Zika virus testing to asymptomatic pregnant women with potential exposure.
The recommendation is based on Zika virus testing performed in U.S. states and the District of Columbia from Jan. 3 to March 5, 2016. The analysis included specimens that were received for testing at the CDC Arboviral Diseases Branch and confirmed Zika virus infection was defined as detection of Zika virus RNA by reverse transcription-polymerase chain reaction, or anti-Zika immunoglobulin M antibodies by enzyme-linked immunosorbent assay with neutralizing antibody titers against Zika virus, at levels greater than or equal to fourfold higher than those against dengue virus.
A total of 4,534 patients were tested: 3,335 (74%) were pregnant women. Among 1,541 patients with one or more Zika virus–associated symptoms, 182 (12%) had confirmed Zika virus infection. Only seven (0.3%) of 2,425 asymptomatic pregnant women who were tested had confirmed Zika virus infection. Of those patients, five resided in areas with active Zika virus transmission at some time during their pregnancy and two were short-term travelers, according to Dr. Sarah Reagan-Steiner of the CDC’s National Center for Immunization and Respiratory Diseases and her coauthors.
“It is reassuring that the proportion of asymptomatic pregnant women with confirmed Zika virus infection in this report was low” and not unexpected in the current U.S. setting, where most exposure to the Zika virus is travel-associated, the investigators wrote.
No conflicts of interested were reported by the authors. Read the full report in MMWR (Morb Mortal Wkly Rep. 2016 Apr 15. doi: 10.15585/mmwr.mm6515e1).
On Twitter @richpizzi
Although the likelihood of Zika virus infection is low among asymptomatic patients, the Centers for Disease Control and Prevention recommends offering Zika virus testing to asymptomatic pregnant women with potential exposure.
The recommendation is based on Zika virus testing performed in U.S. states and the District of Columbia from Jan. 3 to March 5, 2016. The analysis included specimens that were received for testing at the CDC Arboviral Diseases Branch and confirmed Zika virus infection was defined as detection of Zika virus RNA by reverse transcription-polymerase chain reaction, or anti-Zika immunoglobulin M antibodies by enzyme-linked immunosorbent assay with neutralizing antibody titers against Zika virus, at levels greater than or equal to fourfold higher than those against dengue virus.
A total of 4,534 patients were tested: 3,335 (74%) were pregnant women. Among 1,541 patients with one or more Zika virus–associated symptoms, 182 (12%) had confirmed Zika virus infection. Only seven (0.3%) of 2,425 asymptomatic pregnant women who were tested had confirmed Zika virus infection. Of those patients, five resided in areas with active Zika virus transmission at some time during their pregnancy and two were short-term travelers, according to Dr. Sarah Reagan-Steiner of the CDC’s National Center for Immunization and Respiratory Diseases and her coauthors.
“It is reassuring that the proportion of asymptomatic pregnant women with confirmed Zika virus infection in this report was low” and not unexpected in the current U.S. setting, where most exposure to the Zika virus is travel-associated, the investigators wrote.
No conflicts of interested were reported by the authors. Read the full report in MMWR (Morb Mortal Wkly Rep. 2016 Apr 15. doi: 10.15585/mmwr.mm6515e1).
On Twitter @richpizzi
Although the likelihood of Zika virus infection is low among asymptomatic patients, the Centers for Disease Control and Prevention recommends offering Zika virus testing to asymptomatic pregnant women with potential exposure.
The recommendation is based on Zika virus testing performed in U.S. states and the District of Columbia from Jan. 3 to March 5, 2016. The analysis included specimens that were received for testing at the CDC Arboviral Diseases Branch and confirmed Zika virus infection was defined as detection of Zika virus RNA by reverse transcription-polymerase chain reaction, or anti-Zika immunoglobulin M antibodies by enzyme-linked immunosorbent assay with neutralizing antibody titers against Zika virus, at levels greater than or equal to fourfold higher than those against dengue virus.
A total of 4,534 patients were tested: 3,335 (74%) were pregnant women. Among 1,541 patients with one or more Zika virus–associated symptoms, 182 (12%) had confirmed Zika virus infection. Only seven (0.3%) of 2,425 asymptomatic pregnant women who were tested had confirmed Zika virus infection. Of those patients, five resided in areas with active Zika virus transmission at some time during their pregnancy and two were short-term travelers, according to Dr. Sarah Reagan-Steiner of the CDC’s National Center for Immunization and Respiratory Diseases and her coauthors.
“It is reassuring that the proportion of asymptomatic pregnant women with confirmed Zika virus infection in this report was low” and not unexpected in the current U.S. setting, where most exposure to the Zika virus is travel-associated, the investigators wrote.
No conflicts of interested were reported by the authors. Read the full report in MMWR (Morb Mortal Wkly Rep. 2016 Apr 15. doi: 10.15585/mmwr.mm6515e1).
On Twitter @richpizzi
FROM MMWR
