Lancet Infect Dis. 2008 Mar; 8(3):200-7.

PubMed ID: 18291341

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

Boily MC, Abu-Raddad L, Desai K, Masse B, Self S, Anderson R

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.