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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2022, Vol. 27 ›› Issue (2): 190-197.doi: 10.12092/j.issn.1009-2501.2022.02.010

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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

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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