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2009 H1N1 vaccine safe and induces robust immune response in people with asthma
Date:12/13/2010

produce a protective immune response in people with asthma. NIH worked with the Department of Health and Human Services Biomedical Advanced Research and Development Authority to acquire H1N1 vaccine for the study from a U.S.-licensed influenza vaccine manufacturer. The trial was conducted at NHLBI Severe Asthma Research Program (SARP) sites located at university hospitals and centers throughout the United States.

The design of the trial was similar to that of other NIAID-sponsored clinical trials of 2009 H1N1 influenza vaccines in healthy adults. In these trials, a single dose of the vaccine containing 15 micrograms of the influenza hemagglutinin moleculethe main target of the protective antibody responsewas found to be well tolerated and induced a strong immune response in most participants.

The study enrolled 390 people aged 12 to 79 years with asthma. Participants were divided into two groups based on the severity of their asthma. The first group exhibited mild or moderate asthma, and the second group exhibited severe asthma. For the purposes of the study, people with mild or moderate asthma were characterized as needing no or low to moderate doses of inhaled corticosteriods to control their disease symptoms. Those with severe asthma needed high doses of inhaled corticosteriods and frequently required oral corticosteriods to control their symptoms.

Half of the participants in each group received a 15-microgram dose of vaccine, and the other half received a 30-microgram dose, both by injection. Three weeks later, each participant received a second dose in the same amount as the first dose. The vaccine, manufactured by Novartis by methods used to prepare each year's seasonal vaccine, contained inactivated 2009 H1N1 influenza virus and therefore could not cause influenza infection.

The investigators measured the level of antibodies against the 2009 H1N1 influenza virus in participants' blood samples, which were taken three weeks after each injecti
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Contact: NIAID Office of Communications
niaidnews@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
Source:Eurekalert

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