H1N1 Vaccine Clinical Studies in HIV-Infected Individuals
Description
On October 8, 2009, NIAID began clinical trials on H1N1 vaccine with HIV-infected pregnant women. A trial for HIV-infected children and youth began during the week of October 12. These clinical trials will determine whether the 2009 H1N1 influenza vaccine can safely elicit a protective immune response in these groups.
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. Thirty-five sites and eight sub-sites across the United States and Puerto Rico are eligible to conduct the trials.
Because HIV infection and pregnancy both increase the risk for a poor immune response to the normal 15-microgram dose of seasonal influenza vaccine each volunteer will receive two 30-microgram doses of 2009 H1N1 influenza vaccine, 21 days apart. (The NIAID studies of 2009 H1N1 influenza vaccine in HIV-uninfected children, youth and pregnant women are testing doses of 15 and 30 micrograms.)
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.
Safety data will be collected and monitored closely by the study investigators and an independent safety monitoring committee. Novartis Vaccines and Diagnostics manufactured the vaccine used in these trials.
The International Maternal Pediatric Adolescent AIDS Clinical Trials Group is conducting the studies, which are sponsored and funded by NIAID and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), both part of the National Institutes of Health.
Current Status
This trial is now enrolling volunteers.
Related NewsÂ
Oct. 9, 2009
NIH Launches 2009 H1N1 Influenza Vaccine Trials in HIV-Infected Children, Youth and Pregnant Women
Last syndicated: December 08, 2009 11:17 AM EST
This content is brought to you by the National Institute of Allergy and Infectious Diseases (NIAID)
