title: HIV-1 vaccines and adaptive trial designs.
abstract: Developing a vaccine against the human immunodeficiency virus (HIV) poses an exceptional challenge. There are no documented cases of immune-mediated clearance of HIV from an infected individual, and no known correlates of immune protection. Although nonhuman primate models of lentivirus infection have provided valuable data about HIV pathogenesis, such models do not predict HIV vaccine efficacy in humans. The combined lack of a predictive animal model and undefined biomarkers of immune protection against HIV necessitate that vaccines to this pathogen be tested directly in clinical trials. Adaptive clinical trial designs can accelerate vaccine development by rapidly screening out poor vaccines while extending the evaluation of efficacious ones, improving the characterization of promising vaccine candidates and the identification of correlates of immune protection.
authors.affiliation: Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Corey
authors.forename: Gary J
authors.initials: GJ
authors.lastname: Nabel
authors.forename: Carl
authors.initials: C
authors.lastname: Dieffenbach
authors.forename: Peter
authors.initials: P
authors.lastname: Gilbert
authors.forename: Barton F
authors.initials: BF
authors.lastname: Haynes
authors.forename: Margaret
authors.initials: M
authors.lastname: Johnston
authors.forename: James
authors.initials: J
authors.lastname: Kublin
authors.forename: H Clifford
authors.initials: HC
authors.lastname: Lane
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Pantaleo
authors.forename: Louis J
authors.initials: LJ
authors.lastname: Picker
authors.forename: Anthony S
authors.initials: AS
authors.lastname: Fauci
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage / Q000276:immunology; D000818:Animals; D002986:Clinical Trials as Topic; D004195:Disease Models, Animal; D015658:HIV Infections / Q000276:immunology* / Q000517:prevention & control*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D012107:Research Design; D016896:Treatment Outcome
chemical_list: D016915:AIDS Vaccines