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中国临床药理学与治疗学 ›› 2022, Vol. 27 ›› Issue (2): 190-197.doi: 10.12092/j.issn.1009-2501.2022.02.010

• 综述与讲座 • 上一篇    下一篇

新冠病毒疫苗与单克隆中和抗体各期临床试验设计及评价概述

李珊珊1,顾静文1,张菁2,杨海静2,刘薇2,喻一奇3,张文宏3   

  1. 1复旦大学附属华山医院国际医疗中心,2I期临床研究室,3传染科,上海 200040
  • 收稿日期:2021-09-26 修回日期:2022-02-07 出版日期:2022-02-26 发布日期:2022-03-09
  • 通讯作者: 张菁,女,博士,主任药师,博士生导师,研究方向:抗菌药物临床药理学。 E-mail: zhangj_fudan@aliyun.com
  • 作者简介:李珊珊,女,住院医师,博士在读,研究方向:药物I期临床的研究。 E-mail: 13651704786@163.com
  • 基金资助:
    基于良好动物实验的抗新冠肺炎中和抗体的临床前国际合作研究(2021YFE0201900)

Design and evaluation of clinical trials of COVID-19 vaccine and monoclonal neutralizing antibody

LI Shanshan1, GU Jingwen1, ZHANG Jing2, YANG Haijing2, LIU Wei2, YU Yiqi3, ZHANG Wenhong3   

  1. 1Huashan Worldwide Medical Center, 2Phase I Clinical Research Center, 3Department of Infectious Diseases, Huashan Hospital Affiliated to Fudan University, Shanghai 200040, China
  • Received:2021-09-26 Revised:2022-02-07 Online:2022-02-26 Published:2022-03-09

摘要: 2019冠状病毒病(COVID-19)仍在全球蔓延,给公共卫生和全球经济带来了巨大负担。疫苗在控制病毒传播和降低死亡率方面发挥着重要作用。此外,单克隆病毒中和抗体亦可降低病毒载量,改善症状,防止病情加重导致住院。目前约有数百项有关COVID-19疫苗及单克隆中和抗体的临床试验正在进行中,疫苗侧重于疾病的预防,而中和抗体侧重于疾病的治疗。两者临床试验的开展遵循不同的技术指导原则进行,在研究目的、试验设计、试验实施、观察要点及结果评价中存在着较大差异,本文概述两者异同点,为新药研发及临床研究人员参考。

关键词: 疫苗, 单克隆中和抗体, 临床试验, 2019冠状病毒病(COVID-19)

Abstract: COVID-19 pandemic has put a huge burden on public health and global economy. Vaccines play an important role in controlling virus transmission and reducing mortality. While monoclonal virus neutralizing antibodies can reduce the viral load, improve symptoms, and prevent the aggravation of the disease from hospitalization. Now hundreds of clinical trials of COVID-19 vaccine and monoclonal neutralizing antibody are in progress. The vaccine focuses on disease prevention, while the neutralizing antibody focuses on disease treatment. There are quite many differences between the two kinds of clinical trials by following different technical guidelines, research purpose, trial design, implementation and outcome assessment. Therefore, it is necessary to summarize the similarities and differences between the clinical trials for the reference of new drug research and development as well as clinical researchers.

Key words: vaccine, monoclonal neutralizing antibody, clinical trial, COVID-19

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