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抗体依赖性增强作用及对新型冠状病毒疫苗研发的思考
引用本文:邓霞,刘波,王远征,殷霄,苏瑶,张雁,李英丽,高晨燕,杨焕,王涛.抗体依赖性增强作用及对新型冠状病毒疫苗研发的思考[J].中国药物警戒,2021(3).
作者姓名:邓霞  刘波  王远征  殷霄  苏瑶  张雁  李英丽  高晨燕  杨焕  王涛
作者单位:国家药品监督管理局药品审评中心
摘    要:通常情况下病毒性疫苗诱导机体产生的中和抗体能与入侵病毒结合并使其失去感染宿主细胞和发生疾病的能力,但在某些情况下疫苗接种后诱导产生的抗体不但未产生保护作用,反而加重了疾病的临床表现,即通过抗体依赖性增强作用导致疫苗增强性疾病。本文对既往疫苗临床研究和冠状病毒动物试验研究中发生的抗体依赖性增强作用及其可能的作用机制等进行了综述和分析,提出了对新型冠状病毒疫苗研发过程中安全性的思考,为尽早发现和认知抗体依赖性增强作用/疫苗增强性疾病并进行风险控制提供参考。

关 键 词:抗体依赖性增强作用  新型冠状病毒  疫苗  安全性  风险控制

Antibody-Dependent Enhancement of Vaccines and Development of Coronavirus Vaccines
DENG Xia,LIU Bo,WANG Yuanzheng,YIN Xiao,SU Yao,ZHANG Yan,LI Yingli,GAO Chenyan,YANG Huan,WANG Tao.Antibody-Dependent Enhancement of Vaccines and Development of Coronavirus Vaccines[J].Chinese JOurnal of Pharmacovigilance,2021(3).
Authors:DENG Xia  LIU Bo  WANG Yuanzheng  YIN Xiao  SU Yao  ZHANG Yan  LI Yingli  GAO Chenyan  YANG Huan  WANG Tao
Institution:(Center for Drug Evaluation,NMPA,Beijing 100022,China)
Abstract:Generally,the neutralizing antibodies may bind specifically to the invading virus particles,and prevent the virus from entering host cells and developing diseases.However,in some cases,these antibodies not only fail to function well,but also aggravate the clinical manifestations of the disease,known as antibody-dependent enhancement(ADE)that leads to vaccine-enhanced disease(VED).In this article,we investigated and analyzed cases of ADE that had occurred in previous clinical studies or during animal experiments related coronavirus vaccines,and the potential function mechanisms of ADE,and reflected on safety issues concerning the development of coronavirus vaccines,so as to provide reference for the early detection and recognition of ADE and risk control.
Keywords:antibody-dependent enhancement  SARS-CoV-2  vaccine  safety  risk control
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