March 10, 2006

VUMC testing vaccine to battle avian flu

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Deborah Hunter, R.N., a research clinical specialist, administers the avian flu vaccine to trial participant Russell Phillips at Vanderbilt's Clinical Research Center Tuesday.
Photo by Dana Johnson

VUMC testing vaccine to battle avian flu

Infectious Diseases researchers at Vanderbilt University Medical Center are launching a new trial of an avian flu vaccine.

If successful, this trial could help pave the way for an FDA-approved avian flu vaccine to help prevent a potential global health catastrophe.

“We are seeking approximately 100 healthy individuals, ages 18 to 64, for this study. This vaccine is different than the product we tested in our previous avian flu vaccine trial. We'll be giving it with two different adjuvants, which will likely increase the immune response,” said Kathryn Edwards, M.D., vice chair of Pediatric Research and the study's principal investigator. “This is one of the first vaccine studies to be done looking at different adjuvants in combination with the H5N1 virus.”

In a previous study conducted by Edwards, an avian flu vaccine manufactured by Sanofi Pasteur was successfully tested for safety and appropriate immune response in healthy individuals over age 65.

Edwards says by adding an adjuvant, a chemical or compound which can enhance a vaccine's immunologic effect, it is thought that less actual vaccine will be required to produce a sufficient immune response.

“If we can use one-fifth of the vaccine along with an adjuvant, then the vaccine will go five times farther, allowing that many more people to be vaccinated,” she said.

After a relatively slow start during 2003 in Southeast Asia, the avian influenza A/ (H5N1) virus has made a gradual progression into humans in that region, and more recently into humans in Eastern Europe, resulting in the World Health Organization's confirmation of 175 cases and 95 deaths from the virus as of March 6.

The avian flu virus has now been isolated in birds and other small animals in Germany, Africa and even Great Britain. Thus far there have been no documented cases of the H5N1 avian virus in birds, animals or humans in the Western Hemisphere.

“We are using an AH5N1 vaccine, manufactured by Chiron Corp., alone at three different dosages, or combined with either of two different adjuvants, in this case either alum or M-59,” said Deborah Hunter, R.N., B.S.N., clinical research specialist, “It's believed if we attach the vaccine to one or the other of these adjuvants we can use a lower dose of the vaccine and still produce satisfactory results.”

This trial also contains a placebo arm, so some participants will receive a saline placebo and no actual vaccine.

Study participants will be required to make seven total visits to the Clinical Research Center over a period of six months. These visits include an initial screening evaluation, the initial vaccination visit and five follow-up visits.

Study exclusion criteria include individuals who are allergic to eggs, who have autoimmune diseases, or anyone with a current malignancy or history of a malignancy other than skin cancer.

For more information about this study please call (615) 322-4FLU (4358).