NIAID-sponsored clinical trial aims to boost flu vaccine supply

In an effort to expand the supply of flu vaccine available in the United States in the future, a clinical trial of an influenza vaccine widely used in Europe has begun recruiting participants at four sites nationwide. Funding for the study comes from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, which is collaborating with the vaccine's manufacturer, GlaxoSmithKline Biologicals of Rixensart, Belgium, to conduct the study.

The new trial aims to enroll 1,000 healthy adults by December 23rd to assess the immune response and safety of the vaccine. More than 126 million doses of the test vaccine, Fluarix, have been distributed in more than 70 countries worldwide, demonstrating a similar safety profile as U.S.-licensed injectable flu vaccine, but the Fluarix vaccine has never been tested or licensed for use in the United States.

On December 7, however, Department of Health and Human Services Secretary Tommy G. Thompson announced approval of a plan to import up to 4 million doses of Fluarix to be distributed as an "investigational new drug" (IND). Under an IND, volunteers given the Fluarix vaccine must first sign an informed consent form acknowledging that they are aware of the potential risks and benefits associated with the investigational vaccine.

HHS has taken this step to augment the U.S. influenza vaccine supply because earlier this year one of the two manufacturers of U.S.-licensed injectable flu vaccine was unable to deliver its product.

"Expanding the number of influenza vaccine sources is critical as we ready ourselves for next year's flu season," says NIAID Director Anthony S. Fauci, M.D. "The NIAID-supported Vaccine and Treatment Evaluation Units (VTEUs) are structured to perform clinical trials efficiently, enabling us to get needed information rapidly."

"Although the vaccine we are testing has a very long safety record in Europe and other parts of the

Contact: Anne A. Oplinger
NIH/National Institute of Allergy and Infectious Diseases

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