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the antibody response produced. Of the 99 people evaluated in the 90-mcg, high-dose group, 54 percent achieved a neutralizing antibody response to the vaccine at serum dilutions of 1:40 or greater, whereas only 22 percent of the 100 people evaluated who received the 15-mcg dose developed a similar response to the vaccine.

Generally, all dosages of the vaccine appeared to be well tolerated:

• Almost all reported side effects were mild
• The second dose of vaccine did not cause more local or systemic symptoms than the first
• Systemic complaints of fever, malaise, muscle aches, headaches and nausea occurred with the same frequency in all dosage groups as in the placebo group
• Lab tests did not reveal any clinically significant abnormalities

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, NIAID's 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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Contact: NIAID News Office
niaidnews@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
29-Mar-2006

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