Precision and correlation of ED50 and endpoint titer method in measuring HPV vaccine immunogenicity

作者全名："Qiu, Dekui; Liu, Yue; Wang, Zhiping; Zhang, Zhigang; Nie, Meifeng; Xia, Ningshao; Li, Shaowei; Zhao, Qinjian"

作者地址："[Qiu, Dekui; Liu, Yue; Wang, Zhiping; Zhang, Zhigang; Nie, Meifeng; Xia, Ningshao; Li, Shaowei] Xiamen Univ, Natl Inst Diagnost & Vaccine Dev Infect Dis, State Key Lab Mol Vaccinol & Mol Diagnost, Xiamen 361102, Fujian, Peoples R China; [Qiu, Dekui; Liu, Yue; Zhang, Zhigang; Nie, Meifeng; Xia, Ningshao; Li, Shaowei] Xiamen Univ, Sch Publ Hlth, Xiamen 361102, Fujian, Peoples R China; [Wang, Zhiping] Xiamen Univ, Sch Life Sci, Xiamen 361102, Fujian, Peoples R China; [Zhao, Qinjian] Chongqing Med Univ, Coll Pharm, Chongqing 400016, Peoples R China; [Xia, Ningshao; Li, Shaowei] Xiang An Biomed Lab, Xiamen 361102, Fujian, Peoples R China; [Xia, Ningshao] Chinese Acad Med Sci, Res Unit Frontier Technol Struct Vaccinol, Beijing, Peoples R China"

通信作者："Li, SW (通讯作者)，Xiamen Univ, Natl Inst Diagnost & Vaccine Dev Infect Dis, State Key Lab Mol Vaccinol & Mol Diagnost, Xiamen 361102, Fujian, Peoples R China.; Zhao, QJ (通讯作者)，Chongqing Med Univ, Coll Pharm, Chongqing 400016, Peoples R China."

来源：JOURNAL OF VIROLOGICAL METHODS

ESI学科分类：MICROBIOLOGY

WOS号：WOS:001054848900001

JCR分区：Q3

影响因子：2.2

年份：2023

卷号：316

期号：　

开始页：　

结束页：　

文献类型：Article

关键词：Human papillomavirus; Binding titers; Pseudovirion-based neutralization assay; Serological assay; Enzyme-linked immunosorbent assay; Functional assay

摘要："Cervical cancer, the second leading cause of cancer-related deaths among women, is caused by human papillomavirus (HPV), a sexually transmitted virus. Vaccination is an effective preventive measure against viral infections and subsequent development of cervical cancer. Enzyme-linked immunosorbent assay (ELISA) is commonly used to measure specific binding antibody titers and assess the immunogenicity of test vaccines in preclinical models or clinical volunteers. Two methods of deriving titers, the endpoint titer (ET) and the effective dilution producing a median maximal effective fold of dilution (ED50) with a cut-off value, are widely used. For HPV, a pseudovirion-based neutralization assay (PBNA) is used to measure functional antibody titers. The ELISA binding titers and functional PBNA titers were found to be well-correlated for all nine HPV types tested in the vaccine, consistent with previous studies on HPV 16/18. Comparing the PBNA results with the two titration methods, the ED50 method showed higher precision and a closer correlation with PBNA results, both for individual types and pooled data analysis for all nine types. When comparing the titration results of the ET method based on a cut-off value with the ED50 method using all the data points across the dilution series, the ED50 method demonstrated better precision and a stronger correlation with PBNA results."

基金机构："Key Research and Development Program of China [82271873]; Na-tional Natural Science Foundation of China [32070925, 2022CXY0107]; Science and Technology Projects of Xiamen [20720220006]; Fundamental Research Funds for the Central Uni-versities [20720220004, 2019RU022]; CAMS Innovation Fund for Medical Sciences; [2021YFC2301404]"

基金资助正文："This work was supported by grants from the Key Research and Development Program of China (grant no. 2021YFC2301404) , the Na-tional Natural Science Foundation of China (grant no. 82271873, 32070925) , the Science and Technology Projects of Xiamen (grant no. 2022CXY0107) , the Fundamental Research Funds for the Central Uni-versities (grant no. 20720220006, 20720220004) , CAMS Innovation Fund for Medical Sciences (grant no. 2019RU022) ."