人呼吸道合胞病毒中和抗体检测方法的研究进展  

Progress in the detection of neutralizing antibodies to human respiratory syncytial virus

作　　者：张丽 李海 李晓梅 许文波[2] 张燕[2] ZHANG Li;LI Hai;LI Xiaomei;XU Wenbo;ZHANG Yan(Shandong First Medical University&Shandong Academy of Medical Sciences,Jinan,Shandong 250117,China;Key Laboratory of Medical Viruses and Viral Diseases of the National Health Commission,National Institute for Viral Disease Coutrol and Prevention of the China Center for Disease Control and Prevention,WHO Western Pacific Regional Reference Measles/Rubella Laboratory,Beijing 102206,China)

机构地区：[1]山东第一医科大学(山东省医学科学院),山东济南250117 [2]国家卫生健康委员会医学病毒和病毒病重点实验室,中国疾病预防控制中心病毒病预防控制所,世界卫生组织西太平洋地区麻疹/风疹参比实验室,北京102206

出　　处：《中国病毒病杂志》2023年第5期363-369,共7页Chinese Journal of Viral Diseases

基　　金：国家科技重大专项(2018ZX10713-002);北京市自然科学基金(L222122)。

摘　　要：人呼吸道合胞病毒(human respiratory syncytial virus,HRSV)是引起5岁以下儿童、老年人以及免疫功能低下人群急性下呼吸道感染最重要的病毒性病原之一,引起的疾病负担较为严重。经过近70年的研究,全球2款HRSV疫苗(Arexvy和Abrysvo)已获美国食品药品监督管理局批准上市,还有几十种HRSV疫苗处于临床试验阶段,包括重组蛋白疫苗、病毒载体疫苗、减毒活疫苗等。中和抗体是评价HRSV疫苗有效性的一项重要指标。目前,HRSV中和抗体的检测方法主要有微量中和试验和噬斑减少中和试验(plaquereduction neutralization test,PRNT)两大类型,检测方法的不统一在一定程度上阻碍了HRSV疫苗的研发和不同HRSV疫苗效果的评价。目前临床试验中大多数采用免疫染色的PRNT来检测中和抗体的滴度,本文就HRSV疫苗临床试验中使用的中和抗体检测方法进行综述。中和抗体检测方法的不断改进和标准化使得该方法在HRSV疫苗的研发与评价中发挥重要作用,有助于提高中和抗体滴度测定的准确性和可重复性。Human respiratory syncytial virus(HRSV)is a significant viral pathogen that causes acute lower respiratory tract infections in children under 5 years of age,the elderly,and immunocompromised individuals,resulting in heavy disease burden.Recently,two HRSV vaccines(Arexvy and Abrysvo)were approved by the U.S.Food and Drug Administration,after seven decades'research.There are dozens of other HRSV vaccines currently undergoing clinical trials,including recombinant protein vaccines,viral vector vaccines,and attenuated live vaccines,etc.Neutralizing antibodies are an important indicator to assess the efficacy of HRSV vaccines.At present,there are two main types of methods for detecting HRSV neutralizing antibodies,i.e.,microneutralization assay and plaque reduction neutralization test(PRNT).Inconsistency in detection methods have hindered to some extent the development of HRSV vaccines and comparative assessment of the effectiveness of different HRSV vaccines.Most clinical trials now adopt PRNT using immunostaining to measure neutralizing antibody titres.This paper summarized and analyzed the neutralizing antibody detection methods used in clinical trials of HRSV vaccines.With the continuous improvement and standardization of neutralizing antibody detection methods,they play an increasingly important role in the research,development and evaluation of HRSV vaccines,which will help to improve the accuracy and repeatability of measurement of neutralizing antibody titers.

关 键 词：人呼吸道合胞病毒 中和抗体 中和试验 免疫染色 检测方法 

分 类 号：R392[医药卫生—免疫学]