title: A review of the design of vaccine efficacy trials and a proposal for the design of the VA Cooperative Study of Active Immunotherapy of HIV Infection.
abstract: We review the design of vaccine trials based on a search of the medical literature over the past four years, and present the proposed design of a therapeutic HIV vaccine efficacy study by the Department of Veterans Affairs Cooperative Studies Program. We explore the reasons for the atypical design of many vaccine trials, particularly the analysis of efficacy and how it differs from the more usual intent-to-treat analysis used in nonvaccine trials.
authors.affiliation: Cooperative Studies Program, VA Medical Center, West Haven, CT 06516, USA.
authors.forename: P
authors.initials: P
authors.lastname: Peduzzi
authors.forename: S
authors.initials: S
authors.lastname: Donta
authors.forename: M
authors.initials: M
authors.lastname: Iwane
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000276:immunology / Q000628:therapy*; D015982:Bias; D003625:Data Collection; D004311:Double-Blind Method; D015658:HIV Infections / Q000276:immunology / Q000628:therapy*; D006801:Humans; D016233:Immunotherapy, Active; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D012107:Research Design; D016896:Treatment Outcome