发热伴血小板减少综合征布尼亚病毒疫苗候选株的筛选及鉴定  

Screening and identification of severe fever with thrombocytopenia syndrome Bunyavirus vaccine candidate strain

作　　者：杨骏宇[1,2] 焦永军[3] 郭喜玲[3] 许定花 王建梅 承静 陈小芳 金坚[2] 姜东林[2] 

机构地区：[1]无锡鑫连鑫生物医药科技有限公司,江苏无锡214135 [2]江南大学药学院,江苏无锡214122 [3]江苏省疾病预防控制中心,江苏南京210009

出　　处：《中国生物制品学杂志》2014年第10期1243-1247,1252,共6页Chinese Journal of Biologicals

基　　金：科技部国家重大专项--新药创制项目

摘　　要：目的筛选发热伴血小板减少综合征布尼亚病毒(severe fever with thrombocytopenia syndrome bunyavirus,SFTSV)疫苗候选株,为后续疫苗的研制奠定了基础。方法取长成致密单层的Vero细胞,接种疫苗候选株,待细胞充分病变时,收获病毒培养液上清,经病毒滴度、抗体效价、抗原含量、交叉保护性及传代稳定性共5个评价指标筛选SFTSV疫苗生产用毒株,建立3级毒种库,并进行鉴定。结果经首轮筛选获得3株次轮候选株,经次轮筛选确定JS-2011-013株为疫苗生产用毒株,建立的3级种子库经全面检定,均符合《中国药典》三部(2010版)要求。结论已成功获得到SFTSV疫苗生产用毒株,为后续疫苗的研制奠定了基础。Objective To screen severe fever with thrombocytopenia syndrome Bunyavirus（SFTSV） vaccine candidate strain and lay a foundation of further preparation of vaccine. Methods Vero cells which grew into a dense monolayer were inoculated with vaccine candidate strain,of which the supernatant was harvested while sufficiently pathological changes appeared. The strain for production of SFTSV vaccine was evaluated by five indexes,i.e. virus titer,antibody potency,antigen content,cross protection and stability during subculture,based on which a three-tier virus seed bank was established and identified. Results Three second-round candidate strains were obtained after the first-round screening,of which strain JS-2011-013 was defined as the final candidate strain for vaccine production. All the quality indexes of established three-tier seed bank met the requirements in Chinese Pharmacopoeia（Volume Ⅲ）（2010 edition）.Conclusion The SFTS Bunyavirus vaccine candidate strain was obtained successfully,which laid a foundation of further preparation of the vaccine.

关 键 词：发热伴血小板减少综合征 布尼亚病毒 疫苗 候选株 

分 类 号：R373.9[医药卫生—病原生物学] R392.33[医药卫生—基础医学]