Statistical Methods in HIV Vaccine Trial Design and Evaluation

The Global HIV Vaccine Enterprise and the OCTAVE Project (Online Collaborative Training for AIDS Vaccine Evaluation), in close collaboration with the HIV Vaccine Trials Network (HVTN) and the Statistical Center for HIV/AIDS Research & Prevention (SCHARP), hosted a two day workshop focuses on key statistical considerations for the design and analysis of early and late stage vaccine trials.
The HIV vaccine field has entered a new phase of discovery as we probe correlates of protection from a partially effective vaccine regimen evaluated in Thailand, explore novel antibodies capable of neutralizing a majority of circulating viral strains, and design new trials to evaluate a variety of different vaccine concepts.  The objectives of the workshop are:

  • Review fundamental statistical and clinical trial design concepts relevant to vaccine evaluation;
  • Understand the activities of Data Safety and Monitoring Boards; Describe findings from RV144 and explore the approach to define and evaluate correlates of vaccine protection;
  • Describe adaptive trial designs and how they may be used to evaluate the efficacy of multiple vaccine regimens in parallel; Consider study designs that aim to evaluate combination HIV prevention strategies (e.g., vaccines and ARV-based prevention strategies).




This workshop is supported by the NIH Office of AIDS Research and the Global HIV Vaccine Enterprise.  The Capacity-Building Series is a program of the Global HIV Vaccine Enterprise, a unique alliance of independent organizations around the world dedicated to accelerating the development of a preventive HIV vaccine.

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