A randomized controlled trial of HIV therapeutic vaccination using ALVAC with or without Remune

AIDS. 2011 Mar 27;25(6):731-9. doi: 10.1097/QAD.0b013e328344cea5.


Objectives: Therapeutic HIV vaccination during the time of virologic suppression may delay or blunt viral load rebound after interruption of antiretroviral therapy (ART). The use of ALVAC, to enhance cytotoxic T-lymphocyte responses, with Remune, which provides CD4 T-cell help, may induce anti-HIV responses capable of controlling viral replication.

Methods: CTN173 was a randomized, placebo-controlled double-blind study in which effectively treated HIV-infected individuals (viral load <50 copies/ml for more than 2 years) with CD4 nadir more than 250 cells/μl and current CD4 cell counts more than 500 cells/μl were randomized to receive: ALVAC with Remune, ALVAC alone or matching placebos over 20 weeks. At week 24, participants interrupted ART with intensive clinical, virologic and immunologic monitoring to week 48.

Results: Baseline characteristics of the 52 randomized participants were balanced between arms. Forty-eight participants who received all vaccinations interrupted ART at week 24. Median time to viral load more than 50 copies/ml tended to be greater in the two vaccine arms (24.5, 23.0 vs. 13.5 days in the placebo arm, P = 0.097 for combined vaccine groups vs. placebo), but subsequent viral load set-point was not different between groups. Significantly fewer participants in the two vaccine arms restarted ART or met CD4 criteria to do so (P = 0.024).

Conclusion: Although ALVAC with or without Remune did not lower the viral load set-point, it tended to delay viral load rebound and was associated with a greater time to meet preset criteria to restart ART. Further investigations of those individuals who derived benefit from vaccination could provide important insights into HIV therapeutic vaccine development.

Trial registration: ClinicalTrials.gov NCT00212888.

Publication types

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

MeSH terms

  • AIDS Vaccines / therapeutic use*
  • Adult
  • CD4-Positive T-Lymphocytes / drug effects
  • CD4-Positive T-Lymphocytes / immunology*
  • Double-Blind Method
  • Female
  • HIV Infections / immunology
  • HIV Infections / prevention & control
  • HIV Infections / therapy*
  • HIV-1 / immunology*
  • Humans
  • Male
  • Placebos
  • T-Lymphocytes, Cytotoxic / drug effects
  • T-Lymphocytes, Cytotoxic / immunology*
  • Viral Load
  • Viral Vaccines / therapeutic use*


  • AIDS Vaccines
  • ALVAC vaccine
  • Placebos
  • Viral Vaccines
  • remune

Associated data

  • ClinicalTrials.gov/NCT00212888