AIDSVAX
The Participants
150 people enrolled in this trial locally through the HIV Research Section. More than 5,400 volunteers participated across North America, Puerto Rico and Europe.
The Process
Volunteers received 7 injections of either vaccine or placebo over 36 months. Neither the investigators nor the volunteers knew which they received until after the study was over. Participants were given risk reduction counseling with each injection.
The Goal
The trial tested whether a protein resembling the gp120 present on the HIV envelope could engender an antibody response that could prevent HIV infection.
The Results
The results were released in February 2003 and showed that, while the vaccine created a strong antibody response, the vaccine did not protect anyone from becoming infected with HIV.
Lessons Learned
Because this was the first ever Phase III study, it proved that such studies are possible to complete.
People in this study did not significantly increase their risk behavior and did not become HIV infected from the vaccine.
This study reinforced the importance of representing all communities who are in need of an HIV vaccine in vaccine studies. There were not enough people in this study to see if the vaccine worked differently among people of different ages, races or genders.
Finally, we learned that the antibody response to the gp120 protein by itself is not protective. Subsequent vaccine products and studies will be designed with these lessons in mind.
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