Table 1.
HIV Vaccine Efficacy Trials
| Vaccine Strategy | Vaccine Manufacturer(s) and Regimen*† | Trial (Dates Conducted) | Populations and Locations Tested | Seroincidence (No. per 100 PY)†‡ | Results Summary |
|---|---|---|---|---|---|
| Completed Trials | |||||
| Recombinant, monomeric gp120 subunit (B/B; B/E) | VaxGen, Inc IM injections at 0,1,6,12,18,24, and 30 mo |
VAX 004 (1997 2002) | VAX 004: 5417 MSM and heterosexual women in the US, Canada, Netherlands | Men: 2.7 Women 0.8 | Neither VAX 004 or VAX 003 demonstrated efficacy to prevent infection or alter viral load/CD4 count in infected vaccinees36,37 |
| VAX 003 (1999 2003) | VAX 003: 2546 male and female Thai IDU | Overall: 3.4 | |||
| Recombinant Ad 5 (clade B gag/pol/nef) | Merck, Inc. IM injections at 0, 1, and 6 mo |
Step (Merck 023/HVTN 502; 2004–2009) (Phambili HVTN 503;2006 2009) |
3000 MSM, heterosexual men and women in the US, Canada, Caribbean, South America, Australia 801 South African heterosexual men and women |
Men V: 3.8; P: 2.8 Women V: 0.52; P: 0.51 Men V:4.2; P: 3.7 Women V:6.8;P: 5.9 |
No effect on HIV acquisition or early VL set point in Step or Phambili; possible increased HIV infection rate among subgroup of Ad5 seropositive, uncircumcised men in Step5; NS reduction in early VL set point among women in Phambili12 |
| Recombinant Canarypox virus (ALVAC vcp 1521) prime + monomeric gp120 (B/E) boost | Sanofi Aventis (ALVAC) and VaxGen, Inc. IM injections of ALVAC at 0, 1, 3, and 6 mo; gp120 boost at 3 and 6 mo |
RV144 (2003 2009) | 16,402 Thai men and women, largely at heterosexual risk; mostly at low or medium risk of infection | Men V: 0.20; P: 0.27 Women V: 0.19; P: 0.31 |
Modest efficacy to prevent infection in primary MITT 31% (CI 1.1-51%, p=0.04). No effect on postinfection early VL set point or CD4 count23 |
| Ongoing Trials | |||||
| Multiclade DNA prime + multiclade Ad5 boost | NIH Vaccine Research Center IM injections of DNA via Biojector® at 0, 1, and 2 mo; Ad5 boost at 6 mo |
HVTN 505 (2009–) | 1350 US MSM | Currently enrolling | Currently enrolling |
All intramuscular injections delivered via needle and syringe unless otherwise stated.
PY indicates person years; IM, intramuscular; MSM, men who have sex with men; mo, month; NS, non significant; MITT, modified intent to treat; VL, viral load; Ad5, adenovirus serotype 5; HVTN, HIV Vaccine Trials Network; V, vaccine; P, placebo.
For VAX004, overall seroincidence rates are provided for men and women as they were identical in vaccinees and placebo recipients; the pooled and not sex-specific seroincidence estimates for VAX003 were reported by Pitisuttithum, et al. Overall, 201 infections were detected in men (100 in vaccinees, 101 in placebo recipients); 10 infections were detected in women (6 in vaccinees, 4 in placebo recipients).