Lessons from IAVI-006, a phase I clinical trial to evaluate the safety and immunogenicity of the pTHr.HIVA DNA and MVA.HIVA vaccines in a prime-boost strategy to induce HIV-1 specific T-cell responses in healthy volunteers

Vaccine. 2008 Dec 2;26(51):6671-7. doi: 10.1016/j.vaccine.2008.09.016.


IAVI-006 was the first large randomised, double-blinded, placebo-controlled Phase I clinical trial to systematically investigate the prime-boost strategy for induction of HIV-1 specific CD8+ cytotoxic T-lymphocytes (CTL) in a factorial trial design using (i) priming with 0.5 mg or 2 mg of pTHr.HIVA DNA vaccine, followed by (ii) two booster vaccinations with 5 x 10(7) MVA.HIVA at weeks 8 and 12 (early boost) or weeks 20 and 24 (late boost). This study set the basis for later clinical trials and demonstrated the safety of these candidate HIV vaccines. The safety and immunogenicity results are presented and the lessons derived from this clinical trial are discussed.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • AIDS Vaccines / adverse effects
  • AIDS Vaccines / immunology*
  • Adolescent
  • Adult
  • CD8-Positive T-Lymphocytes / immunology*
  • Double-Blind Method
  • Female
  • HIV Infections / prevention & control*
  • HIV-1 / immunology*
  • Humans
  • Immunization, Secondary
  • Male
  • Middle Aged
  • Vaccines, DNA / adverse effects
  • Vaccines, DNA / immunology*
  • Young Adult


  • AIDS Vaccines
  • MVA-HIVA vaccine
  • Vaccines, DNA
  • pTHr.HIVA