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Selection of HIV vaccine candidates for concurrent testing in an efficacy trial.

Publication ,  Journal Article
Huang, Y; DiazGranados, C; Janes, H; Huang, Y; deCamp, AC; Metch, B; Grant, S; Sanchez, B; Phogat, S; Koutsoukos, M; Kanesa-Thasan, N; Gray, G ...
Published in: Curr Opin Virol
April 2016

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.

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Published In

Curr Opin Virol

DOI

EISSN

1879-6265

Publication Date

April 2016

Volume

17

Start / End Page

57 / 65

Location

Netherlands

Related Subject Headings

  • Vaccine Potency
  • Immunogenicity, Vaccine
  • Immunization Schedule
  • Humans
  • HIV-1
  • HIV Infections
  • Data Interpretation, Statistical
  • Clinical Trials as Topic
  • Algorithms
  • AIDS Vaccines
 

Citation

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Huang, Y., DiazGranados, C., Janes, H., deCamp, A. C., Metch, B., Grant, S., … Gilbert, P. B. (2016). Selection of HIV vaccine candidates for concurrent testing in an efficacy trial. Curr Opin Virol, 17, 57–65. https://doi.org/10.1016/j.coviro.2016.01.007
Huang, Ying, Carlos DiazGranados, Holly Janes, Yunda Huang, Allan C. deCamp, Barbara Metch, Shannon Grant, et al. “Selection of HIV vaccine candidates for concurrent testing in an efficacy trial.Curr Opin Virol 17 (April 2016): 57–65. https://doi.org/10.1016/j.coviro.2016.01.007.
Huang Y, DiazGranados C, Janes H, deCamp AC, Metch B, Grant S, et al. Selection of HIV vaccine candidates for concurrent testing in an efficacy trial. Curr Opin Virol. 2016 Apr;17:57–65.
Huang, Ying, et al. “Selection of HIV vaccine candidates for concurrent testing in an efficacy trial.Curr Opin Virol, vol. 17, Apr. 2016, pp. 57–65. Pubmed, doi:10.1016/j.coviro.2016.01.007.
Huang Y, DiazGranados C, Janes H, deCamp AC, Metch B, Grant S, Sanchez B, Phogat S, Koutsoukos M, Kanesa-Thasan N, Bourguignon P, Collard A, Buchbinder S, Tomaras GD, McElrath J, Gray G, Kublin JG, Corey L, Gilbert PB. Selection of HIV vaccine candidates for concurrent testing in an efficacy trial. Curr Opin Virol. 2016 Apr;17:57–65.
Journal cover image

Published In

Curr Opin Virol

DOI

EISSN

1879-6265

Publication Date

April 2016

Volume

17

Start / End Page

57 / 65

Location

Netherlands

Related Subject Headings

  • Vaccine Potency
  • Immunogenicity, Vaccine
  • Immunization Schedule
  • Humans
  • HIV-1
  • HIV Infections
  • Data Interpretation, Statistical
  • Clinical Trials as Topic
  • Algorithms
  • AIDS Vaccines