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Bad news and good news on AIDSVAX Phase III trials results
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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:
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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