THE VIRGINIAN-PILOT Copyright (c) 1996, Landmark Communications, Inc. DATE: Monday, March 25, 1996 TAG: 9603250062 SECTION: FRONT PAGE: A3 EDITION: FINAL SOURCE: KNIGHT-RIDDER NEWS SERVICE DATELINE: PHILADELPHIA LENGTH: Short : 44 lines
The U.S. Food and Drug Administration has approved human testing of a preventive AIDS vaccine made with genetic material from the virus, scientists will announce today.
It would be the first time the government has allowed any DNA-based product to be tested in healthy, uninfected people, according to the vaccine's co-developers at Apollon Inc., a Malvern, Pa., biotechnology company, and the University of Pennsylvania.
The vaccine will be administered to 16 HIV-negative volunteers at the National Institutes of Health in Bethesda, Md. Both safety and effectiveness will be measured during the 18-month study, an Apollon spokesman said.
Two components of the vaccine will be tested separately. The first contains the genes that enable the production of key HIV proteins, including the viral envelope protein. The second component, scheduled for testing later this year, includes the genes that direct production of viral core proteins.
The goal, according to Vincent A. Zurawski, Apollon's president and chief executive, is to develop a vaccine that produces an immune response strong enough to protect against HIV infection, using viral DNA instead of live virus.
The AIDS vaccine is the second from the Apollon-Penn collaboration to reach human trials. In June, they began testing the first DNA-based vaccine ever - this one designed to delay, or halt, the onset of AIDS in people already infected with HIV.
The researchers have found that certain chemicals enhance the potency of DNA-based vaccines. If the technology works, they think it has the potential to work against a host of other diseases as well.
Last Monday, scientists began nationwide trials of Remune, a compound made from killed virus that is designed to stimulate the immune systems of patients already infected with HIV.
KEYWORDS: FDA AIDS DRUG by CNB