U.S. flu clinical trials set to begin

July 22, 2009 at 2:41 PM

BETHESDA, Md., July 22 (UPI) -- Preparations are under way to initiate clinical trials to test 2009 H1N1 flu vaccine candidates, U.S. health officials said Wednesday.

Scientists in a network of medical research facilities across the United States are prepared to begin the trials to gather data about flu vaccines, including the two candidates for the H1N1 strain, the National Institute of Allergy and Infectious Diseases said in a news release.

"With the emergence of the 2009 H1N1 influenza virus, we have undertaken a collaborative and efficient process of vaccine development that is proceeding in stepwise fashion," NIAID Director Anthony S. Fauci said.

The first global human trials of H1N1 vaccines began Wednesday in Australia.

After the virus was isolated and characterized, the U.S. Centers for Disease Control in Atlanta generated and distributed a 2009 H1N1 seed virus to vaccine manufacturers to develop vaccine pilot lots for the clinical trials.

Studies will look at dosage levels for different age populations. A concurrent set of trials will examine the safety and immune response.

"These data will be factored into the decision about how and if to implement a 2009 H1N1 flu immunization program this fall," Fauci said.

Officials said the trials are being conducted in a tight time frame in the face of a possible resurgence of the H1N1 flu infections this fall. Results are expected to be available weeks after the trials begin.

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