Detailed data from HIV vaccine trial released

Additional data from the U.S. Army Surgeon General-sponsored, double-blind, Thai Phase III RV144 trial in 16,402 adult volunteers showed that ALVAC HIV vaccine from sanofi-aventis Group (Euronext:SAN; NYSE:SNY) boosted by the AIDSVAX B/E gp120 vaccine missed the co-primary endpoints in the intent-to-treat (ITT) and per protocol (PP) populations. The regimen lowered the rate of HIV infection by 26.4% vs. placebo at three years in the ITT population, which included all 16,402 subjects who underwent randomization (56 vs. 76 infections, p=0.08). The regimen lowered the rate of HIV infection by 26.2% in the PP population, which included 12,542 subjects (36 vs. 50 infections, p=0.16). Vaccination did not affect viral load, the second co-primary endpoint, or CD4+ count in subjects with HIV infection. Data were reported at the AIDS Vaccine 2009 meeting in Paris and published in the New England Journal of Medicine.

In September, data were reported from the modified intent-to-treat (mITT) population showing that the vaccine and booster significantly lowered the rate of HIV infection by 31.2% vs. placebo at three years (51 vs. 74 infections, p=0.04) (See BioCentury Extra, Thursday, Sep. 24, 2009). ...