AEGiS-GMHC: Treatment Briefs: Large Vaccine Trials Rejected

Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.

Treatment Briefs: Large Vaccine Trials Rejected

Gay Men's Health Crisis: Treatment Issues - Volume 8 no. 6
David Gold

An AIDS advisory committee at the National Institute of Allergy and Infectious Diseases (NIAID) recommended on June 17, against going ahead with large, phase III efficacy trials of two anti-HIV preventive vaccines. The two vaccines consisted solely of the HIV envelope protein gp120. The panel pointed to the $40 million cost for testing the products in 10,000 volunteers and the small likelihood that the vaccines would protect against HIV infection. Dr. Anthony Fauci, the director of NIAID, accepted the recommendation to cancel the proposed trials, calling it a "no brainer." In April, another NIAID panel appointed by Dr. Fauci - the HIV Vaccine Working Group - urged NIAID to go ahead with large gp120 vaccine trials stating that "the scientific rationale supports advancing and expanding clinical trials to evaluate this hypothesis further" (NIAID press release, April 29, 1994). In May, Dr. Fauci outlined a plan for a large "prevention trial" in which some participants would be given gp120 vaccinations.

Activists generally viewed the large trials as an expensive waste of money with very little chance that the gp120 products would successfully prevent HIV infection. Don Francis of Genentech (one of the manufacturers of the gp120 products) and major figure in And the Band Played On seemed a bit peeved at the decision not to go ahead, stating that "this is a sad day. It's about deciding how many people you want to sentence to death before *getting on with the business of vaccination*." [emphasis added]. NIAID officials have so far identified thirteen participants in HIV vaccine trials (mostly of the gp120 products) who have become infected with HIV.

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