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December 11, 2009

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NIAID WEB BULLETIN
NIAID Testing Candidate DNA Vaccine for 2009 H1N1 Influenza


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 vaccines@nih.gov.

Visit www.flu.gov for one-stop access to U.S. government information on avian and pandemic influenza. Also, visit NIAID flu Web portal.

Media inquiries can be directed to the NIAID News and Public Information Branch at 301-402-1663, niaidnews@niaid.nih.gov.


NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at www.niaid.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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Last Updated December 11, 2009