NIH Launches 2009 H1N1 Swine Flu Influenza Vaccine Trials in HIV-Infected Pregnant Women, HIV-Infected Children, and HIV-Infected Youth!

Swine Flu H1N1 Influenza Vaccine Trials have begun. The National Institutes of Health (NIH) launched the first clinical trials, to test whether the 2009 H1N1 Swine Flu influenza vaccine can safely elicit a protective immune response, in three HIV-infected populations—children, youth and pregnant women.

The International Maternal Pediatric Adolescent AIDS Clinical Trials Group is conducting the studies, which are sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, both part of NIH.

“These studies are important because HIV infection and pregnancy both increase the risk for a poor immune response to the normal 15-microgram dose of seasonal influenza vaccine given to the general population,” says NIAID Director Anthony S. Fauci, M.D.

“Moreover, children, young people and pregnant women are at higher risk for . . . more severe illness from the 2009 H1N1 influenza virus than other groups, and HIV-infected individuals in these populations may be particularly vulnerable.”

“Because of the increased vulnerability of these populations, these trials are testing whether  doses of licensed 2009 H1N1 influenza vaccine that are higher than doses being tested in other groups can safely elicit protective immune responses in HIV-infected children, youth and pregnant women,” adds Lynne Mofenson, M.D., chief of the Pediatric, Adolescent and Maternal AIDS Branch in NICHD.

One trial will enroll 130 HIV-infected pregnant women ages 18 to 39 years who are in their second or third trimester (14 to 34 weeks) of pregnancy. The other trial will enroll 140 children and youth aged 4 to 24 years who were infected with HIV at birth.

Safety data will be collected and monitored closely by the study investigators and an independent safety monitoring committee. The strength and longevity of the immune response elicited by the vaccine will be gauged in several ways. The information gathered will be used to finalize the pandemic Swine Flu H1N1 influenza vaccine shots, like was done for the seasonal annual flu influenza vaccine, seasonal flu shot or annual flu shot.

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Reference Swine Flu H1N1 Influenza Vaccine Website:

For more information visit www.flu.gov for one-stop access to U.S. government information on avian-flu and pandemic Swine Flu H1N1 influenza and www.aids.gov for comprehensive U.S. government information about HIV/AIDS. A www.flu.gov webcast on H1N1 and pregnant women featuring NIAID Director Dr. Fauci is available. Also, visit NIAID’s Web portals on influenza and HIV/AIDS.

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