H1N1 Vaccine Clinical Studies in People with Asthma
Description
This clinical trial seeks to determine what dose of the 2009 H1N1 influenza vaccine is needed to induce a protective immune response in people with asthma, especially those with severe disease. The study will enroll approximately 350 people with mild, moderate or 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.
People who have severe asthma may be particularly at risk for infection with the 2009 H1N1 influenza virus. A report published in 2004 suggested that some people who took high doses of glucocorticoids to treat their asthma may receive less protection from influenza vaccines against some strains of influenza. Early in the 2009 H1N1 flu outbreak, a review of hospital records found that people with asthma had a four-fold increased risk of being hospitalized with infection compared to the general population.
The study is cosponsored by NIAID and the National Heart, Lung, and Blood Institute (NHLBI), both part of NIH. The clinical trial will be conducted at seven sites across the United States in NHLBI's Severe Asthma Research Program.
Safety data will be examined throughout 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 that occur 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.
The trial will be enrolling volunteers at study sites including: Cleveland Clinic, Emory University, University of Pittsburgh Asthma Institute, University of Virginia, University of Wisconsin, Wake Forest University, Washington University School of Medicine.
Current Status
This trial is now enrolling volunteers with prior involvement with the NHLBI's Severe Asthma Research Program.
Related News
Oct. 9, 2009
NIH Prepares to Launch 2009 H1N1 Influenza Vaccine Trial in People with Asthma
Last syndicated: December 08, 2009 10:52 AM EST
This content is brought to you by the National Institute of Allergy and Infectious Diseases (NIAID)
