HIV-1 vaccines and adaptive trial designs

Lawrence Corey, Gary J. Nabel, Carl Dieffenbach, Peter Gilbert, Barton F. Haynes, Margaret Johnston, James Kublin, H. Clifford Lane, Giuseppe Pantaleo, Louis J. Picker, Anthony S. Fauci

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52 Scopus citations

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.

Original languageEnglish (US)
Article number79ps13
JournalScience translational medicine
Volume3
Issue number79
DOIs
StatePublished - Apr 20 2011

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ASJC Scopus subject areas

  • Medicine(all)

Cite this

Corey, L., Nabel, G. J., Dieffenbach, C., Gilbert, P., Haynes, B. F., Johnston, M., Kublin, J., Clifford Lane, H., Pantaleo, G., Picker, L. J., & Fauci, A. S. (2011). HIV-1 vaccines and adaptive trial designs. Science translational medicine, 3(79), [79ps13]. https://doi.org/10.1126/scitranslmed.3001863