December 3, 2009
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
For more information about this trial, see H1N1 Vaccine in Pregnant Women.
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Last Updated December 03, 2009