title: Statistical evaluation of HIV vaccines in early clinical trials.
abstract: The HIV pandemic is a pressing threat to global public health; HIV vaccine development is critical. Clinical evaluation of HIV vaccine candidates differs from the standard therapeutics trial framework primarily due to the fact that healthy individuals are studied. We present an early stage evaluation program developed for the HIV Vaccine Trials Network (HVTN) motivated by characteristics unique to the vaccine setting. The program consists of 3 prototypical stages (Phase I, Ib, II) that provide a unified yet flexible approach to the safety and immunogenicity evaluation of diverse vaccine regimens. The goal of these early trials is to narrow the number of candidate vaccines to the most promising candidates worthy of further study in efficacy trials.
authors.affiliation: Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Reasearch Center, 1100 Fairview Ave N, LE-400, PO Box 19024, Seattle, WA 98109-1024, USA. zoe@scharp.org
authors.forename: Zoe
authors.initials: Z
authors.lastname: Moodie
authors.forename: A J
authors.initials: AJ
authors.lastname: Rossini
authors.forename: Michael G
authors.initials: MG
authors.lastname: Hudgens
authors.forename: Peter B
authors.initials: PB
authors.lastname: Gilbert
authors.forename: Steven G
authors.initials: SG
authors.lastname: Self
authors.forename: Nina D
authors.initials: ND
authors.lastname: Russell
mesh_terms: D016915:AIDS Vaccines / Q000276:immunology / Q000627:therapeutic use*; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D017322:Clinical Trials, Phase II as Topic / Q000379:methods*; D003627:Data Interpretation, Statistical; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D015483:HIV Antibodies / Q000097:blood; D015658:HIV Infections / Q000517:prevention & control; D015497:HIV-1 / Q000276:immunology; D006801:Humans; D013601:T-Lymphocytes / Q000276:immunology
chemical_list: D016915:AIDS Vaccines; D015483:HIV Antibodies