HIV-1 Vaccines and Adaptive Trial Designs

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Science Translational Medicine  20 Apr 2011:
Vol. 3, Issue 79, pp. 79ps13
DOI: 10.1126/scitranslmed.3001863


  • Fig. 1.

    Timeline of HIV vaccine efficacy trials. Shown is a time course of the four major clinical efficacy studies of HIV vaccine candidates performed over the past 12 years. The onset and completion of each trial is noted, together with the time required to evaluate efficacy and laboratory analysis. The VaxGen studies analyzed the efficacy of a gp120 recombinant protein product, whereas the STEP trial evaluated efficacy of Ad5 viral vectors designed to stimulate T cell immunity. The RV144 Thai trial tested a canarypox protein combination that stimulated CD4+ T cell and antibody responses.

  • Fig. 2. Adaptive trial designs accelerate vaccine development.

    Alternative approaches are needed to assess the clinical efficacy of HIV vaccines. (A) The traditional approach to testing vaccine efficacy is iterative testing in phase I, II, and III clinical trials. (B) In contrast, adaptive trial designs enable real-time analysis of immunogenicity and vaccine efficacy. This information can be used to make a decision to proceed to phase III efficacy trials much sooner than with a traditional clinical trial approach. The ability to run multiple trials in parallel and focus on an optimal vaccine candidate could save considerable time by avoiding multiple iterations of the phase I, II, and III testing cycle.


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