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新冠病毒疫苗的临床试验:我们目前进展到哪一步了?

The COVID-19 Vaccine in Clinical Trials: Where Are We Now?

作者信息

Jiang Hu-Dachuan, Li Jing-Xin, Zhang Peng, Huo Xiang, Zhu Feng-Cai

机构信息

School of Public Health, Southeast University, Nanjing 210009, China.

Vaccine Clinical Evaluation Department, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China.

出版信息

Infect Dis Immun. 2021 Apr 20;1(1):43-51. doi: 10.1097/ID9.0000000000000003. eCollection 2021 Apr.

Abstract

The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to scale up around the world, costing severe health and economic losses. The development of an effective COVID-19 vaccine is of utmost importance. Most vaccine designs can be classified into three camps: protein based (inactivated vaccines, protein subunit, VLP and T-cell based vaccines), gene based (DNA or RNA vaccines, replicating or non-replicating viral/bacterial vectored vaccines), and a combination of both protein-based and gene-based (live-attenuated virus vaccines). Up to now, 237 candidate vaccines against SARS-CoV-2 are in development worldwide, of which 63 have been approved for clinical trials and 27 are evaluated in phase 3 clinical trials. Six candidate vaccines have been authorized for emergency use or conditional licensed, based on their efficacy data in phase 3 trials. This review summarizes the strengths and weaknesses of the candidate COVID-19 vaccines from various platforms, compares, and discusses their protective efficacy, safety, and immunogenicity according to the published clinical trials results.

摘要

由严重急性呼吸综合征冠状病毒2(SARS-CoV-2)引起的2019冠状病毒病(COVID-19)大流行在全球范围内持续蔓延,造成了严重的健康和经济损失。开发有效的COVID-19疫苗至关重要。大多数疫苗设计可分为三大类:基于蛋白质的(灭活疫苗、蛋白质亚单位疫苗、病毒样颗粒疫苗和基于T细胞的疫苗)、基于基因的(DNA或RNA疫苗、复制型或非复制型病毒/细菌载体疫苗),以及基于蛋白质和基因的组合(减毒活病毒疫苗)。截至目前,全球正在研发237种针对SARS-CoV-2的候选疫苗,其中63种已获批进行临床试验,27种正在进行3期临床试验评估。根据3期试验的疗效数据,6种候选疫苗已获得紧急使用授权或有条件批准上市。本综述总结了来自不同平台的候选COVID-19疫苗的优缺点,并根据已发表的临床试验结果对它们的保护效力、安全性和免疫原性进行比较和讨论。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b799/8057314/f69c825be41b/id9-1-43-g001.jpg

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