title: Selection of HIV vaccine candidates for concurrent testing in an efficacy trial.
abstract: Phase IIb or III HIV-1 vaccine efficacy trials are generally large and operationally challenging. To mitigate this challenge, the HIV Vaccine Trials Network is designing a Phase IIb efficacy trial accommodating the evaluation of multiple vaccine regimens concurrently. As this efficacy trial would evaluate a limited number of vaccine regimens, there is a need to develop a framework for optimizing the strategic selection of regimens from the large number of vaccine candidates tested in Phase I/IIa trials. In this paper we describe the approaches for the selection process, including the choice of immune response endpoints and the statistical criteria and algorithms. We illustrate the selection approaches using data from HIV-1 vaccine trials.
authors.affiliation: Vaccine & Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States. Electronic address: yhuang@fhcrc.org.
authors.forename: Ying
authors.initials: Y
authors.lastname: Huang
authors.affiliation: Sanofi Pasteur, Swiftwater, PA, United States.
authors.forename: Carlos
authors.initials: C
authors.lastname: DiazGranados
authors.affiliation: Vaccine & Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.
authors.forename: Holly
authors.initials: H
authors.lastname: Janes
authors.affiliation: Vaccine & Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.
authors.forename: Yunda
authors.initials: Y
authors.lastname: Huang
authors.affiliation: Vaccine & Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.
authors.forename: Allan C
authors.initials: AC
authors.lastname: deCamp
authors.affiliation: Vaccine & Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.
authors.forename: Barbara
authors.initials: B
authors.lastname: Metch
authors.affiliation: Vaccine & Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.
authors.forename: Shannon
authors.initials: S
authors.lastname: Grant
authors.affiliation: Vaccine & Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.
authors.forename: Brittany
authors.initials: B
authors.lastname: Sanchez
authors.affiliation: Sanofi Pasteur, Swiftwater, PA, United States.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Phogat
authors.affiliation: GlaxoSmithKline Vaccines, Belgium.
authors.forename: Marguerite
authors.initials: M
authors.lastname: Koutsoukos
authors.affiliation: GlaxoSmithKline Vaccines, Belgium.
authors.forename: Niranjan
authors.initials: N
authors.lastname: Kanesa-Thasan
authors.affiliation: GlaxoSmithKline Vaccines, Belgium.
authors.forename: Patricia
authors.initials: P
authors.lastname: Bourguignon
authors.affiliation: GlaxoSmithKline Vaccines, Belgium.
authors.forename: Alix
authors.initials: A
authors.lastname: Collard
authors.affiliation: Department of Medicine and Epidemiology/Biostatistics, UCSF, San Francisco, CA, United States.
authors.forename: Susan
authors.initials: S
authors.lastname: Buchbinder
authors.affiliation: Duke Human Vaccine Institute and Department of Surgery, Duke University Medical Center, Durham, NC, United States.
authors.forename: Georgia D
authors.initials: GD
authors.lastname: Tomaras
authors.affiliation: Vaccine & Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.
authors.forename: Julie
authors.initials: J
authors.lastname: McElrath
authors.affiliation: Perinatnal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Glenda
authors.initials: G
authors.lastname: Gray
authors.affiliation: Vaccine & Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.
authors.forename: James G
authors.initials: JG
authors.lastname: Kublin
authors.affiliation: Vaccine & Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Corey
authors.affiliation: Vaccine & Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States. Electronic address: pgilbert@fhcrc.org.
authors.forename: Peter B
authors.initials: PB
authors.lastname: Gilbert
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage / Q000737:chemistry / Q000276:immunology*; D000465:Algorithms; D002986:Clinical Trials as Topic; D003627:Data Interpretation, Statistical; D015658:HIV Infections / Q000276:immunology / Q000517:prevention & control*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D000071497:Immunogenicity, Vaccine; D064166:Vaccine Potency
chemical_list: D016915:AIDS Vaccines
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