Sci Transl Med. 2011 Apr 20;3(79):79ps13.

HIV-1 vaccines and adaptive trial designs.

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

Source

Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.

Abstract

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.

PMID:: 21508308; [PubMed - indexed for MEDLINE]

MeSH Terms, Substances, Grant Support

MeSH Terms

Substances

AIDS Vaccines

Grant Support

R37 AI054165-10/AI/NIAID NIH HHS/United States

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