PHILADELPHIA Scientists begin AIDS vaccine tests on 1,300 volunteers
The vaccines previously prevented monkeys from acquiring full-blown AIDS.
PHILADELPHIA (AP) -- Scientists at Merck & amp; Co.'s vaccine research headquarters in suburban Philadelphia are testing two experimental AIDS vaccines in early human trials.
In previous tests, the vaccines prevented laboratory monkeys from acquiring full-blown AIDS, although they contracted a version of HIV, the virus that causes AIDS.
Experts believe vaccines are the only way to stop the global AIDS epidemic, which has claimed about 20 million lives and infected an additional 42 million people so far.
"Merck is seen as having one of the broadest programs out there and is developing a candidate that people look at as one of the lead products," said Chris Collins, executive director of the New York-based AIDS Vaccine Advocacy Coalition.
Government, academic and industry researchers trying to develop a vaccine over the past two decades have found the goal elusive.
More than a dozen companies are in the hunt with Merck, including Aventis Pasteur, Wyeth, GlaxoSmithKline PLC, Chiron Corp., VaxGen Inc., AlphaVax Inc. and Epimmune Inc.
Merck's research
Merck, which has a 415-acre vaccine research campus near Lansdale, is conducting 10 Phase 1 studies involving 1,300 volunteers around the country.
The company, based in Whitehouse Station, N.J., won't disclose how much it's spent trying to develop an AIDS vaccine or how many people are working on the project.
Its studies, begun in late 1999, are exploring safety and immune response -- and not whether the vaccine prevents people from getting the disease. Results are expected next year.
If the research is promising, studies on the vaccine's effectiveness in humans could take another three or four years, stretching to 2008 or 2009.
"When could there be an AIDS vaccine? I never answer that question," said Emilio A. Emini, Merck's senior vice president of vaccine and biologicals research. "We'll have to see what the next 10 years bring."
Merck's lead vaccine uses a weakened common-cold virus, known as adenovirus, to carry genetic material from the AIDS virus into the body, in the hopes of producing an immune response to the virus.
Monkeys vs. humans
In studies on monkeys, Merck produced the best immune response when first injecting them with a "naked DNA" inoculation, then boosting it with the adenovirus.
Those monkeys were not free of infection, but the virus remained at low levels, and the monkeys did not get AIDS.
"The real important question is: If you can elicit this kind of response in monkeys, will it make any difference in humans?" Emini said. "And if it does make a difference in natural HIV infection -- and I think it will, and most people believe it will -- what's going to be the nature of that difference?"
VaxGen, a California biotech company, has an experimental AIDS vaccine advance to a final Phase 3 study. However, results released in February show the vaccine did not protect most people from the disease. The company expects to release results of a second large study in Thailand later this year.
"I am really optimistic that we can make a difference against HIV eventually," said Pat Fast, medical director at the International AIDS Vaccine Initiative, which is supported by private donations from the World Bank, the Bill and Melinda Gates Foundation, and others. "It's hard to put a time line on it."
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