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December 3, 2009

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BULLETIN
NIAID to Compare Responses of Pregnant and
Non-Pregnant Women in Clinical Trial
of 2009 H1N1 Influenza Vaccine


A clinical trial comparing immune responses of healthy pregnant and non-pregnant women to an inactivated 2009 H1N1 influenza vaccine has begun enrolling volunteers. A total of 300 women—200 pregnant, 100 not—will be enrolled at six sites nationwide.

Pregnant women are at higher risk than non-pregnant women of developing severe illness as when infected with the 2009 H1N1 influenza virus. This is the first trial to directly compare the immune responses of pregnant and non-pregnant women to the vaccine. The trial also will determine if the immune response in pregnant women, as measured by the amount of antibodies produced, differs depending on whether they receive a larger or smaller dose of vaccine. At delivery, cord blood also will be tested to determine the level of maternal antibodies present in the infant at birth.

The study participants, who are between 18 to 39 years old, will receive 2009 H1N1 vaccine manufactured by Novartis. All the non-pregnant women and half of the pregnant women will receive a single 15-microgram dose of vaccine, while the remaining 100 pregnant women will receive 30 micrograms of vaccine, given in two 15-microgram doses in a single visit. Two injections are required because the trial will use pre-measured, 15-microgram doses of vaccine.

The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The study is being conducted through the NIAID Vaccine and Treatment Evaluation Unit (VTEU) network.

Clinical Trial Sites

  • Baylor College of Medicine, Houston
  • Duke University Medical Center, Durham, NC
  • Group Health Cooperative, Seattle
  • Saint Louis University, St. Louis
  • University of Maryland Medical Center, Baltimore
  • Vanderbilt University Medical Center, Nashville

For more information about this trial, see H1N1 Vaccine in Pregnant Women.

Media inquiries can be directed to the NIAID Office of Communications at 301-402-1663, niaidnews@niaid.nih.gov.


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 www.niaid.nih.gov.

About the National Institutes of Health (NIH): 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. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH...Turning Discovery Into Health ®

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Last Updated December 03, 2009