Clinical Trial Begins For Testing H1N1 Vaccine In Pregnant Women

Main Category: Swine Flu
Also Included In: Pregnancy / Obstetrics;  Immune System / Vaccines
Article Date: 15 Sep 2009 - 2:00 PDT

email to a friend   printer friendly   opinions  

NIH's National Institute of Allergy and Infectious Diseases launched a clinical trial last week to examine the effectiveness of an experimental H1N1 influenza vaccine in pregnant women, a group that health officials consider one of the most susceptible to the disease, CQ HealthBeat reports. NIAID Director Anthony Fauci said that pregnant women are always encouraged to receive seasonal flu vaccines because they are at a higher risk of developing severe illness if they contract the virus. "Data indicate that pregnant women are at higher risk for complications from the 2009 H1N1 flu as well, so this trial will provide critical information for public health planning," Fauci added.

Pregnant women make up 1% of the total population but account for 6% of this year's H1N1 confirmed fatalities. In addition, pregnant women were hospitalized for the disease at a rate four times higher than that of the general population during the initial H1N1 outbreak, according to the Centers for Disease Control and Prevention. When the H1N1 vaccine becomes available, pregnant women will be among the high-priority groups for receiving the shot.

The trial will take place at six sites nationwide and enroll a maximum of 120 pregnant women ages 18 to 39 in their second or third trimester of pregnancy, NIH said. Participants will be injected with 15 or 30 micrograms of a candidate H1N1 vaccine and receive a second dose after 21 days. Study investigators will gather blood samples from the participants at specified times before and after the vaccine is administered. They also will collect umbilical cord blood to measure antibodies passed from the mother to the baby, NIH said. Study investigators and an independent monitoring committee will continuously track the health and safety of the participants. The trial will test a candidate H1N1 vaccine by Sanofi Pasteur, though future trials will include vaccines manufactured by other companies (Attias, CQ HealthBeat, 9/10).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

• Additional
• References
• Citations