Sabin株脊髓灰质炎灭活疫苗毒种的遗传稳定性  

Genetic stability of Sabin strain as virus seed for production of inactivated poliomyelitis vaccine

作　　者：邓燕[1] 朱云[1] 梁海孝[1] 杨璐洁 罗娜[1] 王虓宇[1] 王海[1] 杨卉娟[1] 徐明珏[1] 杨净思[1] 孙明波[1] 

机构地区：[1]中国医学科学院北京协和医学院医学生物学研究所云南省重大传染病疫苗研发重点实验室,云南昆明650118

出　　处：《中国生物制品学杂志》2016年第4期342-347,353,共7页Chinese Journal of Biologicals

基　　金："重大新药创制"科技重大专项(2012ZX09101-318);云南省生物科技重大专项(2012ZX008)

摘　　要：目的分析Sabin株脊髓灰质炎灭活疫苗（inactivated poliomyelitis vaccine,sabin strain,s IPV）毒种（亚主种子、工作种子）及疫苗代次病毒（SO＋4）的遗传稳定性。方法比较疫苗株SabinⅠ、Ⅱ型及PfizerⅢ型亚主种子、工作种子及疫苗代次病毒的感染性滴度及D抗原含量的变化情况,并对上述病毒进行全基因组测序。结果各代次Sabin株病毒滴度均维持在7.62-8.62 lg CCID50/ml,D抗原含量均维持在30-128 DU/ml。与Gen Bank上登录的SabinⅠ（AY184219.1）、Ⅱ（AY184220.1）、Ⅲ型（AY184221.1）减毒株原始种子（SO）基因序列相比,Sabin株亚主种子（SO＋2）、工作种子（SO＋3）及疫苗代次病毒（SO＋4）均未出现碱基突变。结论 s IPV毒种及疫苗代次病毒的全基因序列与原始种子相比,均未发生变化,毒力均一,遗传性状方面保持了较好的稳定性。Objective To analyze the genetic stability of Sabin strain as a virus seed（sub-master and working virus seeds） for production of inactivated poliomyelitis vaccine as well as vaccine virus SO＋4. Methods The sub-master and working seeds of strains SabinⅠ, SabinⅡand Pfizer Ⅲ as well as vaccine virus were determined for infectious titer and D antigen content, of which the complete genomes were sequenced. Results The titers of Sabin strains of various passages were 7. 62 - 8. 26 lg CCID50/ ml, while the D antigen contents were 30 - 128 DU / ml. Compared with the complete genome sequences of SabinⅠ（AY184219. 1）, SabinⅡ（AY184220. 1）and Sabin Ⅲ（AY184221. 1）and attenuated strain of original seed（SO） in Gen Bank, the sub-master seed（SO＋2）, working seed（SO＋3） and vaccine seed virus（SO＋4）of Sabin strain showed no base mutation. Conclusion No change was observed in the complete genome sequence of Sabin strain as virus seed and the vaccine virus compared with that of original seed（SO）, while the virulence was homogeneous, indicating high genetic stability.

关 键 词：Sabin株 脊髓灰质炎灭活疫苗 全基因组测序 遗传稳定性 

分 类 号：R373.2[医药卫生—病原生物学]