Results from a clinical trial demonstrate that high doses of an experimental H5N1 avian influenza vaccine can induce immune responses in healthy adults. Approximately half of those volunteers who received an initial and a booster dose of the highest dosage of the vaccine tested in the trial developed levels of infection-fighting antibodies that current tests predict would neutralize the virus. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, funded the study, published in the current issue of The New England Journal of Medicine. Preliminary results from this trial were first disclosed late last summer.
"These findings represent an important step forward in the nations efforts to prepare for the possible emergence of a human pandemic of H5N1 avian influenza," notes NIH Director Elias A. Zerhouni, M.D.
"We are working hard to address the many challenges that remain with regard to the development of an H5N1 vaccine," adds NIAID Director Anthony S. Fauci, M.D. "For example, potentially protective immune responses were seen most frequently at the highest dose of this vaccine. We are investigating other options that may allow us to reduce the dosage--for example, adding an immune booster, or adjuvant, to the vaccine--so we can achieve a more practical immunization strategy." In addition, the U.S. Department of Health and Human Services is pursuing other approaches to an H5N1 vaccine, including vaccines made in cell cultures rather than grown in eggs.
The vaccine, made from an inactivated H5N1 virus isolated in Southeast Asia in 2004, was manufactured by sanofi pasteur, Swiftwater, PA, under contract to NIAID. Because there are no manufacturers licensed in the United States to use adjuvants in inactivated influenza vaccines, NIAIDs first step was to test an H5N1 influenza vaccine made in a way that mimics the process used to make conventional flu vaccines. The clinical data collected in this study are now available to support the potential use of this vaccine should it be needed for an emerging pandemic.
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