Measuring the public-health impact of candidate HIV vaccines as part of the licensing process

Lancet Infect Dis. 2008 Mar;8(3):200-7. doi: 10.1016/S1473-3099(07)70292-X.

Abstract

The full impact of vaccines against infectious diseases is manifest at both the individual and the community levels. We argue that evaluating the community-level impact of HIV vaccine candidates should be an integral part of the licensing process. We describe a framework for the public-health evaluation of an HIV vaccine, which is based on the interactive use of mathematical models and community randomised clinical trials (C-RCTs) following completion of individual-based clinical trials (I-RCTs). Mathematical models of HIV vaccine can be used to take public-health considerations into account during the licensing process and can also help to select promising vaccine candidates for testing in C-RCTs. We also describe community and individual-based measures useful for defining public-health criteria necessary to guide the licensing process. To move forward, it is crucial to reach a consensus on what should constitute adequate public-health criteria. At the very least, a suitable vaccine would provide some individual benefit to vaccinees and not be detrimental to the population at large. In future I-RCTs and C-RCTs, quantifying each protective vaccine characteristic (eg, reductions in susceptibility or viral load) is important if regulators are to evaluate adequately the potential community-level impact of the vaccine across different settings, populations, and conditions of use.

Publication types

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

MeSH terms

  • AIDS Vaccines / supply & distribution*
  • Communicable Disease Control
  • Developed Countries
  • Developing Countries
  • Endpoint Determination
  • HIV Infections / prevention & control*
  • Humans
  • Licensure*
  • Models, Theoretical
  • Patient Acceptance of Health Care*
  • Public Health
  • Randomized Controlled Trials as Topic*
  • Viral Load

Substances

  • AIDS Vaccines