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Duke To Test Flu Vaccine Effectiveness

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Duke Health News 919-660-1306

DURHAM, N.C. -- A clinical trial to test an influenza vaccine manufactured in Australia begins this month at Duke University Medical Center.

The Duke study is part of a multi-center trial that will test the immune response and reactions of people given the vaccine. CSL Limited, the company manufacturing the vaccine, has been making flu vaccines for nearly 40 years. The trial is sponsored by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

In 2004, nearly half of the normal supply of seasonal influenza vaccine in the United States was unavailable when one of two manufacturers of FDA-licensed flu vaccine had to withdraw its product due to safety concerns. This event highlighted the need for a greater number of manufacturers to make their influenza vaccine available in the United States.

"We need to ensure more secure supplies of influenza vaccine," said Emmanuel Walter, M.D., associate director of the Duke Clinical Research Institute's Primary Care Research Consortium and leader of the Duke study.

Trial participants will receive varying strengths of the vaccine. Volunteers will be randomly assigned to different groups, either receiving one of four formulations of the vaccine or a placebo. As with current flu vaccines given yearly in the U.S., the Australian vaccine causes the body's immune system to make antibodies to fight infection, Walter said.

The study will examine an inactivated flu virus vaccine, made the same way as existing vaccines. "There is no live flu virus in the vaccine, and there is no risk of volunteers contracting flu or spreading it to others," Walter said. More than 40 million doses of the Australian-manufactured vaccine have been administered – reported side effects are very similar to other flu vaccines.

Duke will begin screening potential study volunteers this month. People interested in participating in the study should call (919) 620-5354.

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