Selection of HIV vaccine candidates for concurrent testing in an efficacy trial.

Journal Article (Journal Article;Review)

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.

Full Text

Duke Authors

Cited Authors

  • Huang, Y; DiazGranados, C; Janes, H; Huang, Y; deCamp, AC; Metch, B; Grant, S; Sanchez, B; Phogat, S; Koutsoukos, M; Kanesa-Thasan, N; Bourguignon, P; Collard, A; Buchbinder, S; Tomaras, GD; McElrath, J; Gray, G; Kublin, JG; Corey, L; Gilbert, PB

Published Date

  • April 2016

Published In

Volume / Issue

  • 17 /

Start / End Page

  • 57 - 65

PubMed ID

  • 26827165

Pubmed Central ID

  • PMC4902743

Electronic International Standard Serial Number (EISSN)

  • 1879-6265

Digital Object Identifier (DOI)

  • 10.1016/j.coviro.2016.01.007


  • eng

Conference Location

  • Netherlands