AEGiS-Reuters: Vaxgen gets FDA OK to start HIV vaccine Phase III

Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

Vaxgen gets FDA OK to start HIV vaccine Phase III

Reuters NewMedia, Inc.; Wednesday June 3, 11:02 am EST

SOUTH SAN FRANCISCO, Calif., June 3 (Reuters) - The U.S. Food and Drug Administration has approved Phase III clinical trials for VaxGen Inc.'s AIDSVAX vaccine against HIV, the virus that causes AIDS, the company said Wednesday. VaxGen said it will be the first time an HIV vaccine has been evaluated in a large-scale study in humans in the U.S. It said it expects to begin inoculations at five clinical sites this month.

VaxGen said it is also preparing to conduct Phase III clinical trials in Thailand and expects to receive approval from official agencies, such as the FDA and the Thai Health Ministry, to begin inoculating volunteers there this autumn. In the trials, the company will be testing formulations of AIDSVAX designed to protect against strains of HIV-1 in the Americas, Western Europe, Australia and Southern Asia, where more than 3 billion people remain at risk from these strains of HIV.

VaxGen said it will be investing in research to develop formulations of the vaccine to protect against strains typical in China, India and Africa.

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