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NIAID Launches 2009 H1N1 Influenza Vaccine Trial in Pregnant Women
The first trial testing a candidate 2009 H1N1 influenza vaccine in pregnant
women is launching this week, the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health, announced today.
"Women are at higher risk of developing severe illness if they become infected
with influenza virus while pregnant, which is why they are strongly encouraged
to receive the seasonal influenza vaccine every year," says NIAID Director
Anthony S. Fauci, M.D. "Data indicate that pregnant women are at higher risk for
complications from the 2009 H1N1 influenza virus as well, so this trial will
provide critical information for public health planning."
The trial is being conducted through the NIAID-funded national network of
Vaccine and Treatment Evaluation Units (VTEUs).
"The American public has shown once again its remarkable willingness to step up
and help during an emergency. The interest in this trial has been extraordinary,
and participating medical centers expect to fill all the available slots for
volunteers soon," Dr. Fauci adds.
Up to 120 women 18 to 39 years of age who are in their second or third trimester
(14 to 34 weeks) of pregnancy will be enrolled into this initial trial.
Volunteers will receive 15 micrograms or 30 micrograms of a candidate 2009 H1N1
influenza vaccine manufactured by Sanofi Pasteur. All women will receive an
initial injection and a second injection 21 days later. Safety data will be
collected and assessed continuously throughout the trial by the study
investigators and by an independent safety monitoring committee. Study
investigators will take blood samples to determine how the immune system
responds to the vaccine (for example, by producing antibodies) at set time
points before and following each injection. Cord blood will also be collected to
measure maternal antibodies transferred to the infants through the placenta.
Because the vaccine contains inactivated virus, it is impossible to become
infected with the 2009 H1N1 influenza virus by receiving this vaccine. The
vaccine contains no thimerosal, a preservative, or adjuvant, a substance added
to some vaccines to improve the body's response to vaccine.
The design of this trial in pregnant women is patterned after clinical trials
that opened in August through NIAID's VTEU network. Those trials are testing the
same vaccine in various groups of healthy individuals, including adults, the
elderly and children. The candidate vaccine is also being tested in pregnant
women because they represent a population who public health officials have
recommended to receive a licensed 2009 H1N1 influenza vaccine when it becomes
available this fall.
The trial is taking place at the following six medical centers: Baylor College
of Medicine VTEU in Houston; Group Health Cooperative Center for Health Studies
VTEU in Seattle; Saint Louis University VTEU; Vanderbilt University VTEU in
Nashville; Duke University in Durham, N.C.; and Scott and White Memorial
Hospital and Clinic in Temple, Tex.
In a paper published Aug. 8 in The Lancet, researchers from the Centers for
Disease Control and Prevention reported that six of 45 people (13 percent) who
died from 2009 H1N1 influenza between mid-April and mid-June were pregnant
women. In addition, during the first month of the H1N1 outbreak, the estimated
rate of hospitalization for H1N1 infection in pregnant women was approximately
four times higher than it was in the general population. U.S. public health
officials, following the recommendation of CDC's Advisory Committee on
Immunization Practices, have designated pregnant women among the top priority
groups to receive the 2009 H1N1 influenza vaccine when it becomes available.
Detailed information about this study can be found on the ClinicalTrials.gov Web
site.
H1N1Vaccine in Pregnant Women NCT0093430
http://www.clinicaltrials.gov/ct2/show/NCT00963430?term=NCT00963430&rank=1
NIAID is planning to conduct additional trials in pregnant women testing
candidate 2009 H1N1 influenza vaccines made by other manufacturers.
For more information about NIAID-sponsored clinical trials in pregnant women,
see Questions and Answers: Trial of Candidate 2009 H1N1 Influenza Vaccine in
Pregnant Women
http://www3.niaid.nih.gov/news/QA/H1N1pregnanttrials.htm
Additional information about NIAID-sponsored clinical trials of candidate H1N1
vaccines: Clinical Trials of 2009 H1N1 Influenza Vaccines Conducted by the NIAID-Supported
Vaccine and Treatment Evaluation Units
http://www3.niaid.nih.gov/news/QA/vteuH1N1qa.htm and Pediatric Trials of
Candidate 2009 H1N1 Vaccine at NIAID Vaccine and Treatment Evaluation Units (VTEUs)
http://www3.niaid.nih.gov/news/QA/qaH1N1pedvax.htm
Visit www.flu.gov for one-stop access to U.S. government information on avian
and pandemic influenza. A
www.flu.gov Webcast on H1N1 and pregnant women featuring NIAID Director Dr.
Fauci is available at
http://www.flu.gov/news/knowwhattodo.html#082709
Also, visit NIAID’s flu Web portal
http://www3.niaid.nih.gov/topics/Flu/
NIAID conducts and supports research—at NIH, throughout the United States, and
worldwide—to study the causes of infectious and immune-mediated diseases, and to
develop better means of preventing, diagnosing and treating these illnesses.
News releases, fact sheets and other NIAID-related materials are available on
the NIAID Web site at
http://www.niaid.nih.gov
The National Institutes of Health (NIH) — The Nation's Medical Research Agency —
includes 27 Institutes and Centers and is a component of the U.S. Department of
Health and Human Services. It is the primary federal agency for conducting and
supporting basic, clinical and translational medical research, and it
investigates the causes, treatments, and cures for both common and rare
diseases. For more information about NIH and its programs, visit
www.nih.gov
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Reference: DJ Jamieson et al. H1N1 2009 influenza virus infection during
pregnancy in the USA. The Lancet DOI: 10.1016/S014-6736(09)61304-0 (2009).
