US medical centers seeking volunteers to test bird flu vaccine

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US medical centers seeking volunteers to test bird flu vaccine

Saturday January 28, 03:39 PM

SAN FRANCISCO (AFP) - 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 .

" 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, "

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 .

" 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. "

http://uk.news./28012006/323/medical-centers-seeking-

volunteers-test-bird-flu-vaccine.html