摘要
2019年12月起,新型冠状病毒(以下简称"新冠病毒")率先在国内被检测出,随即在全球蔓延、爆发,虽然目前国内病毒传播得到了控制,但世界其他国家仍处于疫情的高发或平台期。截止到2020年7月26日,世界卫生组织报告新型冠状病毒肺炎(以下简称"新冠肺炎")确诊病例15 581 009例,死亡病例635 173例,然而目前仍没有有效的预防和治疗手段。疫苗被认为是人类面对病毒感染最有效的预防手段,因此,世界各国都在加紧开发新冠病毒疫苗。据世界卫生组织统计,当前已有18款疫苗进入临床Ⅰ期,12款进入临床Ⅱ期,4款进入临床Ⅲ期。在临床研究中,评价疫苗在人体上的安全性和有效性是疫苗临床研究的关键点,同时也是难点。本篇综述将围绕着评估新冠疫苗安全性和有效性的几个关键问题展开讨论。由于前期对SARS和MERS疫苗的研发成果对于新冠疫苗也有一定的借鉴意义,因此,本文将这些成果与目前观察到的新冠病毒感染的临床免疫学特点相结合,以预测新冠疫苗研发可能的瓶颈以及解决思路。
SARS-CoV-2 was first detected in China in December 2019,and spread worldwide.Although the transmission of the SARS-COV-2 has been controlled in China,the number of infected cases continues increasing in many other countries.As of 26 July 2020,15 581 009 individuals infected and 635 173 deaths have been reported according to WHO,without any effective therapeutic or prophylactic interventions discovered.Vaccine has always been considered as one of the most effective prophylactic interventions against such massive outbreaks,thus the development of vaccines against SARS-CoV-2 has been geared up worldwide.According to WHO,there are 18 vaccine candidates ongoing in phase Ⅰ,12 candidates in phase Ⅱ clinical trials and 4 candidates in phase Ⅲ clinical trials currently.Safety and efficacy evaluations of vaccines in humans have always been the key considerations,as well as the main challenges.In this review,we will focus on several key issues for evaluating the safety and efficacy of SARS-CoV-2 vaccines in clinical trials.In addition,based on the previous researches on SARS and MERS vaccines,as well as available clinical immunological characteristics in SARS-CoV-2 infected patients,we will also take a glimpse of the underlying obstacles when developing SARS-CoV-2 vaccines,and the possible solutions.
作者
王宾
钟一维
Wang Bin;Zhong Yiwei(Key Laboratory of Medical Molecular Virology of the Ministry of Education and Ministry of Health,School of Basic Medical Sciences,Fudan University,Shanghai 200032,China)
出处
《中国科学基金》
CSCD
北大核心
2020年第5期581-587,共7页
Bulletin of National Natural Science Foundation of China
作者简介
通信作者:王宾,博士,复旦大学特聘教授,博士生导师,国际疫苗研究所(IVI)科学委员会委员。研究领域:治疗性疫苗和新型疫苗佐剂研究,免疫耐受调控机理研究。发表150多篇SCI论文,主持及参与国家及省部级科研课题30多项。Email:bwang3@fudan.edu.cn,钟一维,复旦大学博士研究生,实验师。任职于复旦大学基础医学院。主要从事新型疫苗和佐剂研究。近5年来相关的研究成果发表在Journal of Immunology,Frontiers in Immunology等杂志上。参与国家自然科学基金重点项目、国家新药创制等课题10多项。
