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Hospital to Hold Tests for Flu Vaccine

Posted on: Saturday, 28 January 2006, 15:00 CST

By John Woolfolk and Steve Johnson, San Jose Mercury News, Calif.

Jan. 28--Stanford University Medical Center is seeking volunteers for human testing of an avian influenza vaccine being developed by Chiron. It will be the first human testing of a vaccine against the deadly virus in the Bay Area.

Stanford hopes to begin the tests as early as next month, and it already has begun recruiting people to begin screening. Three other hospitals also are conducting trials, coordinated by federal health authorities.

But a working vaccine, doctors say, remains a long way from doctors' offices.

"The idea of the tests is to see if the vaccine is safe in humans and if the vaccine produces an immune response in the subjects," said Sally Mackey, a clinical research coordinator in the Stanford University School of Medicine.

Mackey said Stanford hopes to begin screening healthy volunteers ages 18 to 64 in two weeks and expects to use 70 to 100 people for the tests, which involve seven visits over seven months, with the first six visits in the first eight weeks. Volunteers will be paid $30 for each clinic visit.

"We have taken calls from several people," Mackey said. "We're still looking for volunteers."

There's no danger of catching the deadly influenza, or bird flu, from the vaccine being tested, Mackey said.

"It's a killed virus, an inactivated virus, so anyone who participates in our trial would not have any chance of coming down with the flu," Mackey said.

Chiron, an Emeryville biotechnology company, has been one of the nation's major developers of vaccine for seasonal flu and other illnesses. In October, Chiron won a $62.5 million federal contract to help produce a vaccine to counter the threat of a bird flu pandemic. It was the second-largest award for such vaccines announced by the U.S. Department of Health and Human Services. In September, the department awarded $100 million to Sanofi-Aventis of France. Human testing already has begun on the Sanofi-Aventis vaccine.

Both contracts are for a vaccine aimed at defeating the most virulent strain of bird flu, designated H5N1, which has killed more than 70 people in Asia. The victims contracted the disease from close contact with birds. Health officials worry the virus will mutate into a form easily transmitted by people, which could spark a global pandemic and kill millions.

The three other institutions involved in the study are Cincinnati Children's Hospital Medical Center, Vanderbilt University and St. Louis University in Missouri.

The tests are being overseen by the National Institute of Allergy and Infectious Diseases, a branch of the National Institutes of Health. Stanford and other institutions conducting the trials will forward their results to the National Institutes of Health, which then will discuss them with Chiron.

Dr. Cornelia Dekker, associate professor of pediatric infectious diseases and director of the Lucile Packard Children's Hospital vaccine program, said the vaccine was developed with antigens from a patient in Vietnam who had contracted bird flu. Antigens are proteins or carbohydrates that stimulate the body's production of antibodies to fight disease. It is the first time this particular vaccine is being tested in people, she said.

The tests will attempt to determine how much antigen is needed to produce an effective vaccine, and additionally, whether another immune-boosting substance known as an adjuvant also could boost its effectiveness, Dekker said.

"What we hope to learn is how much antibody does the body make in response to various doses of antigen, and does the addition of adjuvant make the vaccine more potent so we can use less of the antigen," Dekker said.

The current trials would identify one or two mixtures of antigens and adjuvants to produce a successful vaccine, which then would undergo wider human testing and then the licensing, Dekker said.

"This is step one," Dekker said. "There are many steps to come."

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IF YOU'RE INTERESTED

Those interested in volunteering for bird flu tests may call the Lucile Packard Children's Hospital vaccine program at (650) 498-7284.

Contact John Woolfolk at jwoolfolk@mercurynews.com or (408) 975-9346.

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Copyright (c) 2006, San Jose Mercury News, Calif.

Distributed by Knight Ridder/Tribune Business News.

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Source: San Jose Mercury News

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