Use of placebos in Phase 1 preventive HIV vaccine clinical trials.
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ABSTRACT:
SUBMITTER: Huang Y
PROVIDER: S-EPMC4554766 | biostudies-literature | 2015 Feb
REPOSITORIES: biostudies-literature
Publications
Use of placebos in Phase 1 preventive HIV vaccine clinical trials.
Huang Yunda Y Karuna Shelly T ST Janes Holly H Frahm Nicole N Nason Martha M Edlefsen Paul T PT Kublin James G JG Corey Lawrence L McElrath M Juliana MJ Gilbert Peter B PB
Vaccine 20141023 6
Phase 1 preventive HIV vaccine trials are often designed as randomized, double-blind studies with the inclusion of placebo recipients. Careful consideration is needed to determine when the inclusion of placebo recipients is highly advantageous and when it is optional for achieving the study objectives of assessing vaccine safety, tolerability and immunogenicity. The inclusion of placebo recipients is generally important to form a reference group that ensures fair evaluation and interpretation of ...[more]
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