水痘减毒活疫苗临床病例病原学分析  

Etiological analysis of clinical cases of live attenuated varicella vaccine

作　　者：权娅茹[1] 袁力勇[1] 陈震[1] 邱平[1] 李长贵[1] QUAN Yaru;YUAN Liyong;CHEN Zhen;QIU Ping;LI Changgui(Division of Respiratory Virus Vaccines,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院呼吸道病毒疫苗室,北京102629

出　　处：《中国生物制品学杂志》2023年第5期589-593,共5页Chinese Journal of Biologicals

基　　金：国家科技重大专项(2018ZX09101001)。

摘　　要：目的对水痘减毒活疫苗临床病例进行病原学分析。方法采集企业水痘减毒活疫苗Ⅲ期临床试验(试验地点为河南省)中临床确诊为水痘病例的49名患者身上的水痘疱疹液,共64份,提取DNA,采用PCR和限制性片段多态性(PCR and restriction fragment length polymorphism,PCR-RFLP)法区分野毒株和疫苗株;采用2008年国际水痘-带状疱疹病毒(varicella-zoster virus,VZV)基因型命名专题会议上建议的基因分型法进行基因型分析。结果64份疱疹液均为野毒型(PstⅠ^(+)SmaⅠ^(-)BssHⅡ^(-)NaeⅠ^(-)),无疫苗相关病例发生。49份疱疹液均为Clade 2遗传支;与Clade 2遗传支相比,49份疱疹液水痘病毒基因均在SNP18082位点发生了T→C同义突变,1份在790位点发生了C→A突变。结论在河南省开展的水痘减毒活疫苗临床试验中的临床病例均为野毒株感染引起,属Clade 2遗传支。Objective To analyze the etiology of clinical cases of live attenuated varicella vaccine.Methods 64 samples of varicella vesicle fluid from 49 patients clinically diagnosed as varicella cases in phase Ⅲ clinical trial of live attenuated varicella vaccine in enterprises(the test site was Henan Province) were collected,extracted for DNA,and distinguished for wild-type strains and vaccine strains by PCR and restriction fragment length polymorphism(PCR-RFLP).Genotype was analyzed using the genotyping method recommended at the international(varicella-zoster virus,VZV) nomenclature meeting2008.Results 64 vesicle fluids were all wild-type strains(Pst Ⅰ^(+)Sma Ⅰ^(-)BssH Ⅱ^(-)Nae Ⅰ^(-)),and no vaccine-related cases occurred.All 49 isolates belonged to Clade 2.Additionally,compared with Clade 2,a synonymous mutation(T→C) in SNP18 082 was detected in all 49 isolates,and a mutation(C→A) in SNP790 was detected in one isolate.Conclusion In the clinical trial of live attenuated varicella vaccine in Henan Province,all the clinical cases were caused by infection of wild-type strain which belonged to Clade 2 genetic branch.

关 键 词：水痘带状疱疹病毒 野毒株 疫苗株 基因分型 

分 类 号：R394[医药卫生—医学遗传学]