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By STEVE WEINSTEIN
Friday, December 12, 2003
Only nine months after VaxGen reported disappointing results for its AIDS vaccine,
the Aaron Diamond AIDS Research Center and the International AIDS Vaccine Initiative
(IAVI) are stepping up to the plate.
The two groups will test a DNA-based vaccine, called Advax, on healthy, non-HIV
infected volunteers in New York and Rochester. The vaccine is specifically
targeted at the “C” strain of HIV, the greatest risk to people
in China and developing nations where HIV infection rates are skyrocketing.
The vaccine is only in its beginning stage, with this trial representing
only the first phase of a long, three-part process as mandated by the federal
Food and Drug Administration. This “safety trial,” will only
determine if administering the vaccine has any side effects; testing whether
it can prevent HIV is much farther down the road.
For this reason, this trial is not looking specifically for gay men. Trial
physician Sarah Schlesinger certainly doesn’t rule them out as volunteer
test subjects, but the trial needs people at very low risk of HIV infection.
Anyone who uses intravenous drugs, has sex for money, or has unsafe sex shouldn’t
participate. “We’re looking for people who engage in safe sex,” Schlesinger
said.
As part of the trial, subjects will be tested for HIV, as well as for a variety
of other indications of well being, such as T-cell counts.
Even though the C strain is most common in Third World countries, the trial
is being conducted in New York (and in Rochester through the University of
Rochester Medical Center) because the Diamond Center is headquartered at Rockefeller
University here.
Advax was invented here by Yaoxing Huang and Dr. David Ho. In an unusual arrangement,
the researchers and the university agreed to relinquish intellectual property
rights to the Chinese government for development in China (provided it works).
In return, the Chinese have expressed their willingness to provide Advax to
other countries “at cost,” according to Schlesinger, who said she
liked that the vaccine was being developed and marketed by two non-profit institutions,
rather than a drug company. IAVI is funding the trial.
“It’s really a different model,” she said. In contrast,
VaxGen’s AIDSVax was being tested, unsuccessfully, for eventual for-profit
sale. AIDSVax contained synthetic versions of proteins found in HIV. The idea,
which followed traditional models for disease vaccines, was the immune system
would become sensitized to these proteins and launch attacks on any virus that
contained them.
By contrast, Advax injects plasma DNA that ultimately, is expected to produce
an immune boost. Since there is no HIV involved, no one exposed to this vaccine
would ever test positive on an AIDS test.
Ho became an internationally known AIDS researcher and landed on the cover
of Time magazine after he discovered the retrovirals. Today, millions of people
with HIV credit their health to so-called HAART, popularly known as an “AIDS
cocktail.”
With UNAIDS reporting about 14,000 new HIV infections daily, researchers like
Dr. Seth Berkley, president of IAVI, now say, “A preventive vaccine is
the world’s best hope to stop the spread of the epidemic.”
Anyone interested in participating in the trial should contact Liz Londono
at 212-448-5126 or 646-258-9847.
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