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January 7, 2011

Safety study to determine the best H1N1 vaccine dose for people with asthma

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People with asthma may have different dosing needs when it comes to getting the new H1N1 influenza vaccine. This may be especially true of people with severe asthma, which is characterized by a poor response to all possible treatments. The vaccine is now available and will be tested on people with asthma who are 12 years of age and older at the University of Virginia Children’s Hospital.

“The corticosteroids prescribed for people with asthma have the potential to suppress the immune system somewhat. Therefore, a typical dose of the H1N1 vaccine may not allow people with severe asthma to build enough antibodies against the H1N1 virus,” says Benjamin Gaston, M.D., professor of pediatrics in the Division of Respiratory Medicine at the UVA Children’s Hospital.

According to Gaston, roughly 5 to 10 percent of people with asthma have a severe case. This group is important because the H1N1 virus has been shown to be more harmful to people with underlying medical problems.

“The study is important because we need to find out whether asthmatics who require high amounts of corticosteroids to control their symptoms may need two doses or a higher dose of the vaccine,” says W. Gerald Teague, M.D., principal investigator of the study and professor of pediatrics in the Division of Respiratory Medicine.

The UVA Children’s Hospital will be one of seven centers from around the country participating in the H1N1 vaccine trial for people with asthma. Gaston and Teague hope to enroll 60 to 70 volunteers who will participate over a 201 day period. People with both mild to moderate and severe asthma who want to participate must have been diagnosed by their physician as having asthma. This will be confirmed by a screening questionnaire and additional research tests. Participants in the study will be randomized to receive either the standard dose (15 mcg) or a 30 mcg dose given twice during the study. The study will measure the response to the vaccine based on asthma severity by comparing results in volunteers with severe asthma to volunteers with mild-to-moderate asthma. Participants will primarily come from the Severe Asthma Research Program (SARP) at UVA as well those outside of SARP who qualify.

Those with documented asthma, who are interested in participating in the SARP and the H1N1 vaccine trial, should call the study coordinator at 434-924-1781.

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