The National Institute of Allergy and Infectious Diseases (NIAID) launched the first trial testing a candidate 2009 H1N1 influenza vaccine in pregnant women. NIAID Director Anthony S. Fauci, M.D. said, “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. 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). 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. 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. http://www.nih.gov/news/health/sep2009/niaid-09.htm