THE WORLD'S first wide-scale efficacy testing of a vaccine to prevent AIDS received the go-ahead from the Food and Drug Administration last month, although some scientists remain skeptical about its prospects for success.
The approval allows VaxGen, Inc, a South San Francisco, Calif, biotechnology company that developed the experimental vaccine, called AIDSVAX, to go forward with a 3-year, placebo-controlled phase 3 efficacy trial involving 5000 volunteers at high risk for HIV infection in as many as 40 clinics in the United States and Canada. Once the necessary approvals are secured from Thai health officials, the company expects to begin enrolling 2500 volunteers in 16 clinics in Thailand later this year in a similar trial involving a slightly different vaccine formulation.
Stephenson J. AIDS Vaccine Moves Into Phase 3 Trials. JAMA. 1998;280(1):7-8. doi:10.1001/jama.280.1.7