H1N1 Influenza (Swine Flu)
December 11, 2009
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has completed enrollment in a small clinical trial testing a candidate DNA vaccine for 2009 H1N1 influenza. Researchers at the NIAID Vaccine Research Center (VRC) designed the vaccine, which contains a gene encoding a major surface protein, hemagglutinin, of the H1N1 influenza virus. A pilot lot of the vaccine for use in the trial was manufactured at the NIAID/VRC Vaccine Pilot Plant in Frederick, Md.
The trial is assessing the safety of the vaccine and its ability to elicit an immune response. The vaccine was administered to the first volunteer on August 24 at the NIH Clinical Center. The fully enrolled trial includes 20 healthy volunteers between the ages of 18 and 70.
All participants will receive three four-milligram injections of the vaccine, given at an initial time point and at 28 and 56 days thereafter. Safety data are being collected at follow-up visits between vaccinations. The candidate vaccine does not contain the whole 2009 H1N1 influenza virus or any infectious material, and thus it is impossible to become infected with influenza by receiving the vaccine. Participation in this trial does not preclude volunteers from receiving conventional vaccines against H1N1 influenza in the future.
DNA vaccines are an experimental class of vaccine in which genetic material from the pathogen is injected directly into the body. According to VRC Director Gary Nabel, M.D., Ph.D., DNA vaccines hold the promise of being faster to produce than standard vaccines. In addition, DNA vaccines may elicit an immune response that includes the production of both antibodies and infection-fighting cells that could provide cross-protection against other influenza viruses.
Further information about this clinical trial can be found at ClinicalTrials.gov: 09-I-0204: An Open-Label Phase I Study of the Safety and Immunogenicity of Investigational H1 DNA Influenza Vaccine, VRC-FLUDNA057-00-VP, in Healthy Adults 18-70 Years Old
The VRC also is conducting other Phase I influenza vaccine clinical trials at NIH. Individuals interested in enrolling in VRC vaccine research studies can contact the VRC toll-free at 1-866-833-LIFE (5433), or by e-mail at email@example.com.
Visit www.flu.gov for one-stop access to U.S. government information on avian and pandemic influenza. Also, visit NIAID flu Web portal.
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Last Updated December 11, 2009