| Literature DB >> 26827165 |
Ying Huang1, Carlos DiazGranados2, Holly Janes3, Yunda Huang3, Allan C deCamp3, Barbara Metch3, Shannon Grant3, Brittany Sanchez3, Sanjay Phogat2, Marguerite Koutsoukos4, Niranjan Kanesa-Thasan4, Patricia Bourguignon4, Alix Collard4, Susan Buchbinder5, Georgia D Tomaras6, Julie McElrath3, Glenda Gray7, James G Kublin3, Lawrence Corey3, Peter B Gilbert8.
Abstract
Phase IIb or III HIV-1 vaccine efficacy trials are generally large and operationally challenging. To mitigate this challenge, the HIV Vaccine Trials Network is designing a Phase IIb efficacy trial accommodating the evaluation of multiple vaccine regimens concurrently. As this efficacy trial would evaluate a limited number of vaccine regimens, there is a need to develop a framework for optimizing the strategic selection of regimens from the large number of vaccine candidates tested in Phase I/IIa trials. In this paper we describe the approaches for the selection process, including the choice of immune response endpoints and the statistical criteria and algorithms. We illustrate the selection approaches using data from HIV-1 vaccine trials.Entities:
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Year: 2016 PMID： 26827165 PMCID： PMC4902743 DOI： 10.1016/j.coviro.2016.01.007
Source DB: PubMed Journal: Curr Opin Virol ISSN： 1879-6257 Impact factor: 7.090