The Safety and Efficacy of an H1N1 Influenza Vaccine in People with Asthma study was a seven-site cooperative study sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart Lung and Blood Institute (NHLBI). The study was developed in the months following the outbreak of the 2009 H1N1 pandemic to assess the safety and immunogenicity of the H1N1 influenza vaccine in 390 healthy adults, ages 12 and older, with severe versus mild-to-moderate asthma.
The study was initiated because there were concerns in the healthcare community about the vulnerability of individuals with asthma to the H1N1 virus. Researchers wanted to ensure that the vaccine was safe for individuals with asthma, but also effective at triggering the desired immune response. The researchers found that a single dose of the standard H1N1 vaccine – the same dose as recommended for the general population – provided adequate seroprotection against the H1N1 virus in the study population with no safety concerns.
Rho serves as the statistical and data coordinating center for the study, which is managed by Herman Mitchell, Ph.D., Vice President, Federal Operations.
Learn more about this project at http://clinicaltrials.gov/ct2/show/NCT00978120.
This is a closed project.