FDA Go-Ahead For Salk HIV Vaccine Trials

The US Food and Drug Administration has given approval for large-scale trials of the Salk AIDS vaccine, a gp120-depleted inactivated HIV-1 immunogen devised by polio vaccine pioneer Jonas Salk, despite the fact that preliminary trials of the agent suggest it is hardly more effective than placebo.

At the FDA's Vaccines & Related Biological Products Advisory Committee meeting on January 26, Immunization Products Ltd (a joint venture between Immune Response and Rhone-Poulenc Rorer) presented data from two Phase II trials of the immunotherapeutic.

The first trial, coded 104, tested four doses of the immunogen (50, 100, 200 and 400mcg) against a control of incomplete Freund's adjuvant in 48 patients with HIV. Patients received total doses of up to 2,400mcg cumulatively over six months with no obvious ill effects. Various improving trends were seen in the treated patients compared to the controls, but most of these differences were not significant, said Ronald Moss, medical director at IPL.