BETHESDA, Md., Oct. 12 (UPI) -- A U.S. government-sponsored clinical trial is determining what dose of the H1N1 flu vaccine is needed for people with severe asthma, health officials said.
The study is co-sponsored by the National Institute of Allergy and Infectious Diseases and the National Heart, Lung, and Blood Institute, both part of National Institute of Health.
"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 H1N1 influenza virus," Dr. Anthony S. Fauci, director National Institute of Allergy and Infectious Diseases, said in a statement. "We need to determine the optimal dose of 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 U.S. Food and Drug Administration for review. With FDA allowing it to proceed, the clinical trial will be conducted at seven U.S. sites that participate in National Heart, Lung, and Blood Institute's Severe Asthma Research Program.
The clinical trials of H1N1 influenza vaccines in healthy adults have shown that a single 15-microgram dose of vaccine is well tolerated and induces a strong immune response in most healthy participants.
