HIV Vaccine Study First to Show Some Effectiveness in Preventing HIV
ROCKVILLE, Md.,
"This is the first HIV vaccine candidate to successfully reduce the risk of HIV infection in humans. We are very excited and pleased with the outcome of this trial and congratulate all those who participated in it," said
In the final analysis, 74 placebo recipients became infected with HIV compared to 51 in the vaccine regimen arm. The efficacy result is statistically significant. The vaccine regimen had no effect on the amount of virus in the blood of volunteers who became HIV-infected during the study. More detailed results of this study will be presented next month at the AIDS Vaccine Conference,
This finding has important implications for the design of future HIV vaccines and how they are tested, however additional research is needed to better understand how this vaccine regimen reduced the risk of HIV infection. Given the significant threat of HIV infection worldwide, an efficacious vaccine is urgently needed, as part of a broader prevention effort to help control the epidemic.
Collaborating partners on this study, referred to as RV144, include the U.S. Army, the Thai Ministry of Public Health, the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, sanofi pasteur, and Global Solutions for Infectious Diseases (GSID). The collaborators are already working with external experts to determine the need for additional studies on this vaccine regimen and consider the impact of this study's findings on other HIV vaccine candidates.
"These results show that development of a safe and effective preventive HIV vaccine is possible, " said
The U.S. Army would like to thank the more than 16,000 Thai men and women who consented to participate in this trial and the efforts of the Thai Ministry of Public Health and all collaborators for their hard work in achieving this important milestone.
RV144 Phase III Trial Background
RV144 tested a prime-boost vaccine strategy that combined two vaccines based on strains (subtypes) of HIV that circulate in
The proof-of-concept study, which began in 2003, was designed to evaluate the vaccine strategy's ability to prevent HIV infection, as well as its ability to reduce the amount of HIV in the blood of those who became infected after they enrolled in the study.
More than 16,000 HIV-negative men and women between the ages of 18 to 30 participated in the study; half of these participants received the prime-boost vaccine regimen and half received placebo. Volunteers received vaccinations over the course of six-months and were followed for an additional three-years. Before agreeing to participate, all volunteers were informed of the potential risks associated with receiving the experimental vaccine regimen used in this study and consented to participate in the study. Volunteers continued to receive an HIV test every six-months for three-years following vaccination, in addition to counseling on how to prevent becoming infected with HIV.
For additional information, please visit www.hivresearch.org
For further information: Lisa Reilly of the U.S. Military HIV Research Program, +1-301-251-5070, [email protected]; or Mary Jane Walker of Hill & Knowlton, +1-917-763-6769, [email protected], for the U.S. Military HIV Research Program Web Site: http://www.hivresearch.org
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