HIV-1 vaccines and adaptive trial designs.

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Corey, L; Nabel, GJ; Dieffenbach, C; Gilbert, P; Haynes, BF; Johnston, M; Kublin, J; Lane, HC; Pantaleo, G; Picker, LJ; Fauci, AS

Published Date

  • April 20, 2011

Published In

Volume / Issue

  • 3 / 79

Start / End Page

  • 79ps13 -

PubMed ID

  • 21508308

Pubmed Central ID

  • 21508308

Electronic International Standard Serial Number (EISSN)

  • 1946-6242

Digital Object Identifier (DOI)

  • 10.1126/scitranslmed.3001863

Language

  • eng

Conference Location

  • United States