COVID-19 疫苗的免疫学替代终点：我们现有的证据与我们所需的证据。
Immunological surrogate endpoints of COVID-2019 vaccines: the evidence we have versus the evidence we need.
机构信息
Department of Vaccine Clinical Evaluation, Jiangsu Province Center for Disease Control and Prevention, Nanjing, China.
NHC Key laboratory of Enteric Pathogenic Microbiology, Nanjing, China.
出版信息
Signal Transduct Target Ther. 2021 Feb 2;6(1):48. doi: 10.1038/s41392-021-00481-y.
Abstract
In response to the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic, over 200 vaccine candidates against coronavirus disease 2019 (COVID-2019) are under development and currently moving forward at an unparalleled speed. The availability of surrogate endpoints would help to avoid large-scale filed efficacy trials and facilitate the approval of vaccine candidates, which is crucial to control COVID-19 pandemic. Several phase 3 efficacy trials of COVID-19 vaccine candidates are under way, which provide opportunities for the determination of COVID-19 correlates of protection. In this paper, we review current knowledge for existence of COVID-19 correlates of protection, methods for assessment of immune correlates of protection and issues related to COVID-19 correlates of protection.
摘要
针对严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）大流行，目前正在开发 200 多种针对 2019 年冠状病毒病（COVID-19）的疫苗候选物，其推进速度前所未有。替代终点的出现将有助于避免大规模的现场疗效试验，并促进疫苗候选物的批准，这对于控制 COVID-19 大流行至关重要。目前正在进行几项 COVID-19 疫苗候选物的 3 期疗效试验，为确定 COVID-19 保护相关因素提供了机会。在本文中，我们回顾了 COVID-19 保护相关因素的现有知识、评估免疫保护相关因素的方法以及与 COVID-19 保护相关因素相关的问题。
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