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.