Vaxgen announces disappointing results from first large international vaccine trial

Bad news and good news on AIDSVAX phase III trials results

Vaxgen Inc has announced the initial results from its three-year Phase III trials of AIDSVAX, a recombinant gp120 HIV vaccine.

The reduction of HIV infection within the vaccinated population as a whole was not statistically significant. However, there was a statistically significant reduction of HIV infection in vaccinated non-white, non-Hispanic volunteers. More importantly, protection in this subgroup appeared to correlate with a higher level of neutralising antibodies.

Phillip Berman, VaxGen’s senior vice president of Research and Development and inventor of the vaccine remarked that this is the first time they had specific numbers that suggested that a vaccine had prevented HIV infection in humans. He added that they were not sure why some subgroups of volunteers had a better immune response, but that the preliminary data indicated that a vaccine constructed with the virus’ surface protein could elicit neutralizing antibodies that correlated with protection of infection.

AIDSVAX B/B Trial Statistics
No. of volunteers to complete 3 immunizations: 5,009
Placebo recipients: 1,679
AIDSVAX B/B recipients: 3,330
White volunteers: 4,185
Hispanic volunteers: 326
Non-white volunteers (Black, Asian, Other): 498
Black volunteers: 314
Annual study infection rate 2.7%
Approximate Efficacy (after at least 3 primary doses)
All volunteers: 3.8% (p-value = 0.76; confidence interval: -23% to 24%)
Non-white volunteers: 67% (p-value < 0.01; confidence interval: 30% to 84%)
Black volunteers: 78% (p-value < 0.02; confidence interval: 29% to 93%)


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