title: In pursuit of an HIV vaccine: designing efficacy trials in the context of partially effective nonvaccine prevention modalities.
abstract: The HIV prevention landscape is evolving rapidly, and future efficacy trials of candidate vaccines, which remain the best long-term option for stemming the HIV epidemic, will be conducted in the context of partially effective nonvaccine prevention modalities. It is essential that these trials provide for valid and efficient evaluation of vaccine efficacy and immune correlates. The availability of partially effective prevention modalities presents opportunities to study their interactions with vaccines to maximally reduce HIV incidence. This article proposes an approach for conducting future vaccine efficacy trials in the context of background use of partially effective nonvaccine prevention modalities, and for conducting future vaccine efficacy trials that provide nonvaccine prevention modalities in one or more of the randomized study groups. Strategies are discussed for responding to emerging evidence on nonvaccine prevention modalities during ongoing vaccine trials. Next-generation HIV vaccine efficacy trials will almost certainly be more complex in their design and implementation but may become more relevant to at-risk populations and better suited to the ultimate goal of reducing HIV incidence at the population level.
authors.affiliation: 1 Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center , Seattle, Washington.
authors.forename: Holly
authors.initials: H
authors.lastname: Janes
authors.forename: Peter
authors.initials: P
authors.lastname: Gilbert
authors.forename: Susan
authors.initials: S
authors.lastname: Buchbinder
authors.forename: James
authors.initials: J
authors.lastname: Kublin
authors.forename: Magdalena E
authors.initials: ME
authors.lastname: Sobieszczyk
authors.forename: Scott M
authors.initials: SM
authors.lastname: Hammer
mesh_terms: D016915:AIDS Vaccines / Q000627:therapeutic use*; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D035843:Biomedical Research / Q000379:methods*; D018890:Chemoprevention / Q000379:methods*; D003131:Combined Modality Therapy; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D008297:Male; D012107:Research Design
chemical_list: D016915:AIDS Vaccines; D000890:Anti-Infective Agents