NIAID trial of 2009 H1N1 influenza vaccine enrolling HIV-positive adults

HIV-infected adults are being recruited to participate in a clinical trial of 2009 H1N1 influenza vaccine, the National Institutes of Health announced Dec. 10.

The study, sponsored by the National Institute of Allergy and Infectious Diseases, will enroll approximately 240 men and women between the ages of 18 and 64.

"People with suppressed immunity caused by conditions such as HIV infection are at increased risk of serious illness from 2009 H1N1 influenza, and should be vaccinated against the H1N1 virus," said Anthony S. Fauci, director of the NIAID.

"However, such immune suppression may hamper the response to influenza vaccines,” Fauci added. "While people with HIV infection are a high-priority group to receive 2009 H1N1 influenza vaccine, the optimal dosage of 2009 H1N1 vaccine for people with HIV infection has not been determined through clinical trials. This study will help address that gap in knowledge."

All study participants will receive two doses of an inactivated 2009 H1N1 influenza vaccine, administered approximately 21 days apart. The vaccine is manufactured by Novartis. Half of the volunteers will receive two 15-microgram doses and the other half two 30-microgram doses of the vaccine.

The trial is being conducted at six sites, including these five NIAID-funded Vaccine and Treatment Evaluation Units: Baylor College of Medicine, Houston; Cincinnati Children’s Hospital Medical Center; Saint Louis University, Mo.; University of Iowa, Iowa City; and University of Maryland, Baltimore. The University of Washington, Seattle, also is participating in the trial.

The new study is the third NIAID-sponsored trial of 2009 H1N1 influenza vaccine in people with HIV infection. The earlier trials began in October and enrolled HIV-infected pregnant women and children and young adults with HIV.

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