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Bad news and good news on AIDSVAX Phase III trials results
  February 24, 2003. Vaxgen, Inc. announced today 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 neutralizing antibodies.
Phillip Berman, Ph.D., VaxGen's senior vice president of Research and Development and inventor of the vaccine remarked that this is the first time we have specific numbers that suggest that a vaccine has prevented HIV infection in humans. He added that they are not sure why some subgroups of volunteers have a better immune response, but that the preliminary data indicate that a vaccine constructed with the virus' surface protein could elicit neutralizing antibodies that correlated with protection of infection.
AIDSVAX B/B Trial Statistics
Number of volunteers to complete three immunizations:
Placebo recipients:
AIDSVAX B/B recipients:
White volunteers:
Hispanic volunteers:
Non-white volunteers (Black, Asian, Other):
Black volunteers:
Annual study infection rate
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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