Oasis Advanced Wellness Health Forum

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US medical centers seeking volunteers to test bird flu vaccine


Medical centers in four US states are seeking volunteers for the first human testing of a bird flu vaccine made in Britain by Chiron Corporation, researchers said.

Stanford Medical Center, in Palo Alto near San Francisco, is one of four centers recruiting "healthy subjects" to be injected with "inactive influenza A/H5N1 vaccine," said research assistant Ernesto Martin Gonzalez.

"The emergence of the avian influenza virus strains in human populations outside of the US has added urgency to ongoing efforts to develop plans for responding to potential world-wide outbreak," Gonzalez said in a release calling for volunteers.

Stanford vaccine program director Cornelia Dekker told AFP it will be the first time this particular vaccine is tested in humans.

A Sanofi Pasteur bird flu vaccine was tested in human volunteers last year, with the August results showing that large doses triggered anti-body levels on par with those seen with common flu vaccines, Dekker said.

The French pharmaceutical firm's vaccine has gone on testing in people age 65 and older, a group considered more at risk of dying from bird flu, Dekker said.

Since the Chiron and Sanofi vaccines are chemically similar, the testing being launched in the United States is focused on seeing whether chemicals called "adjuvants" can boost the potency, Dekker said.

"The new study added two adjuvants in the mix to increase the immune response and make it possible to use less vaccine, and thereby have more doses for more people," Dekker said.

"It is a checkerboard mix-and-match of vaccine and adjuvants to come up with the most promising combinations."

The US National Institutes of Health (NIH) is looking to Chiron and Sanofi Pasteur to make bird flu vaccines for a US stockpile, according to Dekker. The NIH is sponsoring the new study.

Scientists fear the bird flu's H5N1 strain may mutate into a form easily transmissible between humans and trigger a pandemic that could kill millions around the world.

A total of 280 subjects are being sought for testing at Stanford and medical centers in the states of Ohio, Tennessee, and Missouri, Dekker said.

Volunteers will undergo health screening, and sound candidates will get two injections, one in each arm, about a week apart. The trials are to begin in February, according to the medical center.

There will be nine groups, eight of them given different vaccine-adjuvant combinations and the ninth a control group injected with a placebo.

"Assignment to groups will be random, like a coin toss," Dekker said. "They won't know and we won't know what group they are in."

Researchers will watch for ill effects and determine the efficacy of the vaccines by checking antibody levels.

Volunteers will be required to make seven clinic visits for shots, blood tests and check-ups during the course of about eight months. They will be paid 30 dollars per clinic visit, according to Gonzalez.

"We are doing it as fast as we can to provide results as quickly as possible so people can make decisions on what to do next," Dekker said.

"The goal is to have something, even if imperfect, rather than nothing," Dekker said. "The other option is to treat people after they become ill, and that is much more difficult in a pandemic situation."