假病毒中和试验在重组脊髓灰质炎疫苗免疫原性评价和大鼠效力试验的初步应用  

Preliminary application of pseudovirus in evaluating the immunogenicity of recombinant poliovirus vaccines and in rat potency tests

作　　者：刘悦越[1] 杜丽芳 陈实 赵荣荣[1] 郑凡 丁玲 马智静 张靖 马萌 赵素华 梁宇 李启明 权娅茹[1] Liu Yueyue;Du Lifang;Chen Shi;Zhao Rongrong;Zheng Fan;Ding Ling;Ma Zhijing;Zhang Jing;Ma Meng;Zhao Suhua;Liang Yu;Li Qiming;Quan Yaru(Division of Respiratory Virus Vaccines,NHC Key Laboratory of Research on Quality and Standardization of Biotech Products,NMPA Key Laboratory for Quality Research and Evaluation of Biological Products,National Institutes for Food and Drug Control,Beijing 102629,China;The Sixth Laboratory,State Key Laboratory of Novel Vaccines for Emerging Infectious Diseases,National Vaccine and Serum Institute,Beijing 101111,China;Department of Quality Control,Beijing Institute of Biological Products Co.,Ltd.,Beijing 100176,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,国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室,国家药品监督管理局生物制品质量研究与评价重点实验室,北京102629 [2]国药中生生物技术研究院(新型疫苗国家工程研究中心)第六研究室,新突发传染病新型疫苗研发全国重点实验室,北京101111 [3]北京生物制品研究所有限责任公司质量检定室,北京100176

出　　处：《中华微生物学和免疫学杂志》2024年第9期778-783,共6页Chinese Journal of Microbiology and Immunology

基　　金：北京市科技计划项目(Z221100007922048)。

摘　　要：目的初步研究基于脊髓灰质炎假病毒的中和试验在重组脊髓灰质炎疫苗的免疫原性评价和大鼠效力试验中的适用性。方法对重组脊髓灰质炎疫苗免疫后的大鼠血清同时采用假病毒中和试验和Sabin株中和试验进行检测,分别采用Kappa检验和Spearman秩相关分析两种方法的一致性和相关性。结果针对Ⅰ、Ⅱ、Ⅲ型脊髓灰质炎病毒中和抗体,两种方法一致性检验的Kappa值分别为0.914、1.000、0.751;相关系数R值分别为0.833、0.927、0.859,P值均<0.001。结论两种方法的结果具有一致性,相关性较好,表明脊髓灰质炎假病毒中和试验可用于疫苗免疫原性评价和大鼠效力试验。ObjectiveTo preliminarily investigate the applicability of a poliovirus pseudovirus-based neutralization assay in evaluating the immunogenicity of recombinant poliovirus vaccines and their in vivo potency in rats.MethodsSerum samples from rats immunized with recombinant poliovirus vaccines were tested using both the pseudovirus neutralization assay and the live-virus neutralization assay with Sabin strain.The consistency and correlation of the two methods were analyzed using the Kappa test and Spearman′s rank correlation.ResultsFor the neutralizing antibodies against typeⅠ,Ⅱ,andⅢpolioviruses,the Kappa values for consistency analysis of the two methods were 0.914,1.000,and 0.751,respectively(P<0.001),and the correlation coefficients(R values)were 0.833,0.927,and 0.859,respectively(P<0.001).ConclusionsThe test results of the two methods are consistent and show a good correlation,indicating that the pseudovirus neutralization assay can be applied to evaluating the immunogenicity of poliovirus vaccines and also can be used in rat potency tests.

关 键 词：假病毒 脊髓灰质炎 重组脊髓灰质炎疫苗 

分 类 号：R392[医药卫生—免疫学]