Use of placebos in Phase 1 preventive HIV vaccine clinical trials

Vaccine. 2015 Feb 4;33(6):749-52. doi: 10.1016/j.vaccine.2014.10.017. Epub 2014 Oct 23.

Abstract

Phase 1 preventive HIV vaccine trials are often designed as randomized, double-blind studies with the inclusion of placebo recipients. Careful consideration is needed to determine when the inclusion of placebo recipients is highly advantageous and when it is optional for achieving the study objectives of assessing vaccine safety, tolerability and immunogenicity. The inclusion of placebo recipients is generally important to form a reference group that ensures fair evaluation and interpretation of subjective study endpoints, or endpoints whose levels may change due to exposures besides vaccination. In some settings, however, placebo recipients are less important because other data sources and tools are available to achieve the study objectives.

Keywords: Blinding; Clinical trial; Randomization; Sample sizes; Vaccine immunogenicity; Vaccine safety; Vaccine tolerability.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • AIDS Vaccines / administration & dosage
  • AIDS Vaccines / immunology*
  • Clinical Trials, Phase I as Topic*
  • Double-Blind Method
  • HIV Infections / immunology
  • HIV Infections / prevention & control*
  • HIV Infections / virology
  • HIV-1 / immunology
  • Humans
  • Placebos
  • Randomized Controlled Trials as Topic*
  • Research Design*
  • Vaccination*

Substances

  • AIDS Vaccines
  • Placebos