title: Malaria vaccine trial endpoints - bridging the gaps between trial design, public health and the next generation of vaccines.
abstract: A recent working group convened by the World Health Organization recommended that time to first or only episode of clinical malaria should be used to evaluate vaccine efficacy in phase III trials. However, calculating vaccine efficacy based on this endpoint misses important aspects of malaria disease and transmission. Here, we discuss the gaps that this approach leaves in predicting the potential public health impact of a vaccine and the challenges faced by vaccine trial designers. We examine the implications of current vaccine trial design on effectiveness studies and the next generation of malaria vaccines.
authors.affiliation: Fogarty International Center, National Institutes of Health, Bethesda, MD, USA. wendypomeara@gmail.com
authors.forename: W P
authors.initials: WP
authors.lastname: O'Meara
authors.forename: T
authors.initials: T
authors.lastname: Lang
mesh_terms: D015415:Biomarkers; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D008288:Malaria / Q000453:epidemiology* / Q000517:prevention & control*; D017780:Malaria Vaccines / Q000276:immunology*; D012107:Research Design; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D017780:Malaria Vaccines