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Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials.

Devan V MehrotraHolly E JanesThomas R FlemingPaula W AnnunziatoKathleen M NeuzilLindsay N CarppDavid C BenkeserElizabeth R BrownMarco CaroneIksung ChoDeborah J DonnellMichael P FayYouyi FongShu HanIan HirschYing HuangYunda HuangOllivier HyrienMichal JuraskaAlex LuedtkeMartha C NasonAn VandeboschHonghong ZhouMyron S CohenLawrence CoreyJonathan HartzelDean A FollmannPeter B Gilbert
Published in: Annals of internal medicine (2020)
Several vaccine candidates to protect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or coronavirus disease 2019 (COVID-19) have entered or will soon enter large-scale, phase 3, placebo-controlled randomized clinical trials. To facilitate harmonized evaluation and comparison of the efficacy of these vaccines, a general set of clinical endpoints is proposed, along with considerations to guide the selection of the primary endpoints on the basis of clinical and statistical reasoning. The plausibility that vaccine protection against symptomatic COVID-19 could be accompanied by a shift toward more SARS-CoV-2 infections that are asymptomatic is highlighted, as well as the potential implications of such a shift.
Keyphrases
  • respiratory syndrome coronavirus
  • coronavirus disease
  • sars cov
  • clinical trial
  • radiation therapy
  • risk assessment
  • open label
  • phase iii
  • locally advanced
  • human health
  • double blind