Rerks-Ngarm S. MOPH-TAVEG Investigators. NEJM 2009; 361: 1.
Background: After disappointing results with a glycoprotein 120 (gp120) B/B (AIDSVAX B/B) vaccine and a canary pox vector ALVAC-HIV vCP1452 vaccine, there was some promise after the initial failure of the AIDSVAX B/E vaccine alone in IVDU but proof of some efficacy with the ALVAC-HIV plus AIDSVAX B/E (prime-boost) has led to this large test-of-concept study.
Methods: Community-based, randomized, multicenter, double-blind, placebo-controlled efficacy trial. Recruited Thai men and women, 18-30, not infected with HIV, without controlling for HIV risk. 26,676 assessed, 17,350 screened, and 16,402 randomized. Follow-up is 3 years.
Treatment: Vaccines administered at baseline (day 0), and then 4, 12, and 24 weeks later. ALVAC-HIV administered at all four visits, the AIDSVAX boost at the 2nd & 4th visit.
Results:
Primary Endpoint: HIV Infection
All subjects: RRR 31.2%, ARR (per person-years) 0.00087, NNT 1149/person-years, ARR 0.0029 (study), NNT 350
*Note: There was no difference in the high risk population (22/1896 v 23/1929)
Postinfection Viral Load & CD4+ T-Cell Count: no difference
Secondary Endpoint: Immunogenicity, relevance unknown
T-cell-line adapted neutralizing antibody: 71% response
Antibody-directed, cell-mediated cytotoxicity, CD4+ lymphoproliferation:61% response to gp20 MN, 63% response to gp120 CM244CD8+ T-cells: 24% response to (51)Cr-release cytotoxic T-cell assay, 17% +ELISPOT
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