title: Measuring the public-health impact of candidate HIV vaccines as part of the licensing process.
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.
authors.affiliation: Department of Infectious Diseases, Faculty of Medicine, Imperial College, London, UK. mc.boily@ic.ac.uk
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Boily
authors.forename: Laith
authors.initials: L
authors.lastname: Abu-Raddad
authors.forename: Kamal
authors.initials: K
authors.lastname: Desai
authors.forename: Benoit
authors.initials: B
authors.lastname: Masse
authors.forename: Steve
authors.initials: S
authors.lastname: Self
authors.forename: Roy
authors.initials: R
authors.lastname: Anderson
mesh_terms: D016915:AIDS Vaccines / Q000600:supply & distribution*; D003140:Communicable Disease Control; D019049:Developed Countries; D003906:Developing Countries; D023381:Endpoint Determination; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D008004:Licensure; D008962:Models, Theoretical; D010342:Patient Acceptance of Health Care; D011634:Public Health; D016032:Randomized Controlled Trials as Topic; D019562:Viral Load
chemical_list: D016915:AIDS Vaccines