Table 1.
HIV vaccine Phase II/III trials
| Trial | Date | Vaccine components | Country | Populations | Main immunological target | Infection rates |
|---|---|---|---|---|---|---|
| Vax004 | 1998–2002 | Recombinant gp120 (B/B) | United States Canada Netherlands |
5403 HRSTs |
Neutralising antibody | 6.7% in vaccinees 7.0% in placebo recipients NS |
| Vax 003 | 1999–2002 | Recombinant gp120 (B/E) | Thailand | 2546 IDU |
Neutralising antibody | 8.4% in vaccinees 8.3% in placebo recipients NS |
| Step | 2004–2007 | rAd5 (gag, pol, nef) (B) | North America Caribbean South America Australia |
3000 HRST |
CD8 T cell responses | 4.6% in vaccinees 3.1% in placebo recipients P=0.07* |
| Phambili | 2007 | rAd5 (gag, pol, nef) (B) | South Africa | 801 HRST** |
CD8 T cell responses | 8.4% in vaccinees 7% in placebo recipients P=NS |
| RV144 (Thai trial) | 2003–2009 |
Prime: canarypox (gag, pol, env E) Boost: recombinant gp120 (B/E) |
Thailand | 16,402 General population |
Neutralising antibody | 0.192% in vaccinees 0.279% in placebo recipients P=0.04; VE=31%*** |
| HVTN 505 | 2009–2013 |
Prime: DNA (gag, pol, nef, B) + DNA (env A/B/C) Boost: Ad5 (gag, pol, B) + Ad5 (env A/B/C) |
United States | 2496 HRST |
CD8 T cell responses | 2.7% in vaccinees 2.1% in placebo recipients P=NS |
HRST: high risk for sexual transmission; IDU: intravenous drug users; IR: infection rate ; VE: vaccine efficacy.
*
Analysis in men in the Step trial (all but one infection occurred in men); ** enrolment of 3000 patients was originally planned but the trial was stopped after the results of the Step trial; *** Modified intention-to-treat analysis.