Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
Reuters NewMedia, Inc.; Tuesday June 23 7:53 PM EDT
VaxGen, a privately held South San Francisco biotechnology company that developed the vaccine, known as AIDSVAX, said volunteers at a clinic in Philadelphia received their first shots in the trial.
Clinics in Baltimore, Chicago, Denver, Los Angeles and St. Louis were expected to begin vaccinations in coming weeks.
The Phase III clinical trial -- usually the last step before the U.S. Food and Drug Administration considers whether to allow a company to market a drug or vaccine -- will eventually involve 5,000 volunteers at more than 30 cities across North America.
There are more than 40 HIV vaccines in trials, but AIDSVAX is the first to make it this far in the FDA approval process.
The trial will use volunteers who are at high risk of becoming infected with HIV through sexual transmission -- primarily gay men and people with HIV-positive partners.
Each volunteer will receive seven inoculations during a 30-month period. Some will receive the vaccine and others a placebo, an inactive substance used in controlled experiments to determine the efficacy of a vaccine. Neither researchers nor volunteers will know which people are given the vaccine.
But at the end of the trial, the rate of infections in the group receiving the placebo will be compared to the infection rate, if any, among volunteers who received the vaccine.
The company, which is 25 percent-owned by Genentech Inc., said it also anticipated beginning Phase III trials of a separate formulation of AIDSVAX in Thailand later this year, following approval by the Thai Ministry of Health.
The vaccine uses gp120, one of the surface proteins on the coat of the HIV virus. The idea is that using one of the unique proteins would be enough to stimulate the body's immune system to recognize and attack the viral invaders.
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