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新冠疫苗临床试验综述——一个缺失拼图碎片的谜题。

Review of Covid-19 vaccine clinical trials - A puzzle with missing pieces.

作者信息

Kwok Hang Fai

机构信息

Institute of Translational Medicine, Faculty of Health Sciences, University of Macau, Avenida de Universidade, Taipa, Macau SAR.

出版信息

Int J Biol Sci. 2021 Apr 10;17(6):1461-1468. doi: 10.7150/ijbs.59170. eCollection 2021.

Abstract

A year after the initial outbreak of Covid-19 pandemic, several Phase III clinical trials investigating vaccine safety and efficacy have been published. These vaccine candidates were developed by different research groups and pharmaceutical companies with various vaccine technologies including mRNA, recombinant protein, adenoviral vector and inactivated virus-based platforms. Despite numerous successful clinical trials, participants enrolled in these trials are limited by trial inclusion and exclusion criteria, geographic location and viral outbreak situation. Many questions still remain, especially for specific subgroups, including the elderly, females with pregnancy and breastfeeding status, and adolescents. At the same time, vaccine efficacy towards asymptomatic infection and specific viral variants are still largely unknown. This review will cover vaccine candidates with Phase III clinical trial data released and discuss the scientific data available so far for these vaccine candidates for different subgroups of people and different viral variants.

摘要

在新冠疫情首次爆发一年后,多项调查疫苗安全性和有效性的III期临床试验已发表。这些候选疫苗由不同的研究小组和制药公司采用多种疫苗技术研发,包括信使核糖核酸(mRNA)、重组蛋白、腺病毒载体和基于灭活病毒的平台。尽管有众多成功的临床试验,但参与这些试验的受试者受到试验纳入和排除标准、地理位置以及病毒爆发情况的限制。许多问题仍然存在,尤其是针对特定亚组人群,包括老年人、处于妊娠和哺乳期的女性以及青少年。与此同时,疫苗对无症状感染和特定病毒变体的有效性仍然很大程度上未知。本综述将涵盖已发布III期临床试验数据的候选疫苗,并讨论目前针对不同人群亚组和不同病毒变体的这些候选疫苗的可用科学数据。

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