H1N1 Vaccine Clinical Trial Conducted on Asthmatics

The National Institutes of Health (NIH) is preparing to launch the first government-sponsored clinical trial to determine what dose of the 2009 H1N1 influenza vaccine is needed to induce a protective immune response in people with asthma, especially severe asthmatics. The study is cosponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung, and Blood Institute (NHLBI), both part of NIH.

“People with severe asthma often take high doses of glucocorticoids that can suppress their immune system, placing them at greater risk for infection and possibly serious disease caused by 2009 H1N1 influenza virus,” says Doctor Anthony S. Fauci, NIAID director. “We need to determine the optimal dose of 2009 H1N1 influenza vaccine that can be safely administered to this at-risk population and whether one or two doses are needed to produce an immune response that is predictive of protection.”

The study plan has been submitted to the Food and Drug Administration (FDA) for review. With FDA allowing it to proceed, the clinical trial will be conducted at seven sites across the United States that participate in NHLBI’s Severe Asthma Research Program.

The trial will be conducted at the following locations:

• Cleveland Clinic, Ohio
• Emory University, Atlanta
• University of Pittsburgh Asthma Institute
• University of Virginia, Charlottesville
• University of Wisconsin, Madison
• Wake Forest University, Winston-Salem, N.C.
• Washington University School of Medicine, St. Louis

The study will enroll approximately 350 people with mild, moderate, and severe asthma. Participants will be organized into two groups: those with mild or moderate asthma and those with severe asthma. Half of the participants in each group will receive a 15-microgram dose of vaccine, and the other half a 30-microgram dose. Three weeks later, each participant will receive a second dose of the same amount. The strength of the immune response induced by the vaccine will be determined in blood samples by measuring the level of antibodies against 2009 H1N1 flu virus.

Safety data will be collected and examined throughout the course of the study by trial investigators and by an independent safety monitoring committee. Participants will be monitored for any side effects they may experience because of the vaccine, as well as asthma attacks occurring during the study period.

The vaccine to be used in the trial, manufactured by Novartis, contains inactivated 2009 H1N1 influenza virus and therefore cannot cause anyone to become infected with the virus.

Detailed information about this study can be found on the ClinicalTrials.gov Web site.

The information above is an excerpt of an Oct. 9 NIH press release.

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