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Detailed Results from RV 144 HIV Vaccine Trial Published Today in The New England Journal of Medicine and Presented at the AIDS Vaccine 2009 Conference Provide Insight for Future Research
Date:10/20/2009

these trial results afford - a new vantage point to examine what we understand about vaccine design, immunogenicity testing and animal models," added Colonel Kim. "Further research is required to determine if immunological mechanisms mediating protection against HIV may be different from those that control viral replication."

The trial results, first announced by trial collaborators on September 24, 2009, are based on the mITT population, which is the most clinically relevant analysis for this proof-of-concept study. Data from the mITT population, which was monitored by the independent Data and Safety Monitoring Board during its periodic review of the study, include all volunteers who entered the study less seven individuals who were already HIV infected on the first day of vaccination. "Given that you cannot protect someone from an infection that they already have acquired, the modified intent-to-treat analysis excluded these individuals," said Michael.

The detailed study data, which were embargoed for release before the AIDS Vaccine 2009 Conference and The New England Journal of Medicine publication, provide analyses of multiple data subgroups including ITT and per protocol (PP), their definitions and results. Data from the PP population show similar trends (26.2 percent reduction in HIV infection compared to placebo; n=36 vs. n= 50 respectively; p=0.16), though the results did not reach statistical significance due to the exclusion of nearly one-third of volunteers from the analysis and the associated loss of statistical power. For the ITT population, the vaccine regimen reduced infection rates by 26.4 percent compared to placebo (n=56 vs. n=76 respectively; p=0.08).

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. Trial collaborators include the U.S. Army, the Thai Ministry of Public Health, Mahid
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SOURCE U.S. Military HIV Research Program
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