Preliminary application of pseudovirus in evaluating the immunogenicity of recombinant poliovirus vaccines and in rat potency tests
10.3760/cma.j.cn112309-20240719-00270
- VernacularTitle: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
- Author:
Yueyue LIU
1
;
Lifang DU
;
Shi CHEN
;
Rongrong ZHAO
;
Fan ZHENG
;
Ling DING
;
Zhijing MA
;
Jing ZHANG
;
Meng MA
;
Suhua ZHAO
;
Yu LIANG
;
Qiming LI
;
Yaru QUAN
Author Information
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
- Keywords:
Pseudovirus;
Poliovirus;
Recombinant poliovirus vaccine
- From:
Chinese Journal of Microbiology and Immunology
2024;44(9):778-783
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To 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. Methods:Serum 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.Results:For the neutralizing antibodies against typeⅠ, Ⅱ, and Ⅲ polioviruses, 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). Conclusions:The 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.
