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

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.