H1N1 Influenza

The National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland, has announced that HIV-positive adults between the ages of 18 and 64 years are being actively recruited to participate in a clinical trial of the 2009 H1N1 influenza vaccine.

The goal is to enroll 240 volunteers for the trial, half with CD4+ T-cell counts below 200 cells/mm³, and half with CD4+ T-cell counts equal to or greater than 200 cells/mm³. The objective is to assess CD4+ T-cell response to the vaccine.

Study participants will receive 2 doses of Novartis’ inactivated 2009 H1N1 influenza vaccine, administered 21 days apart. Half will receive two 15-μg doses, and half will receive two 30-μg doses. Each dose group will contain 60 patients with CD4+ T-cell counts below 200 cells/mm³ and 60 patients with CD4+ counts of 200 cells/mm³ or higher.

The trial is being conducted at 6 sites. Five sites are NIAID-funded Vaccine and Treatment Evaluation Units. They are Baylor College of Medicine, Houston, Texas; Cincinnati (Ohio) Children’s Hospital Medical Center; Saint Louis University, Missouri; the University of Iowa, Iowa City; and the University of Maryland, Baltimore. The sixth site is the University of Washington, Seattle.

“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. However, such immune suppression may hamper the response to influenza vaccines,” NIAID Director Anthony S. Fauci, MD, said yesterday in an NIAID release announcing the launch.