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Efficacy, Safety, and Immunogenicity of an Escherichia coli-Produced Bivalent Human Papillomavirus Vaccine: An Interim Analysis of a Randomized Clinical Trial

Authors :
Ying Hong
Mei Li
Jun Zhao
Ningshao Xia
Xuelian Cui
Xin Wu
Meng Guo
Shaowei Li
Bin Zhao
Fang-Hui Zhao
Wen Chen
Hui Zhao
Yingying Su
Yun-Fei Jiang
Ba-Yi Li
Juan Li
Wen-hua Zhang
Fengxian Zheng
Wen-Yu Liu
Junzhi Wang
Jun Zhang
Cui-Hong Dai
Yanping Li
Shoujie Huang
Huirong Pan
Chao Zhao
Xun Zhang
Ting Wu
Jie Tang
Lihui Wei
Li-Dong Ke
Dong-Ping Guo
Changgui Li
You-Lin Qiao
Zhijie Lin
Yimin Li
Kai Chu
Rong-Cheng Li
Caihong Li
Yuemei Hu
Fengcai Zhu
Guo-Qi Gao
Qin-Jing Pan
Mingqiang Li
Qing Li
Source :
J Natl Cancer Inst
Publication Year :
2019
Publisher :
Oxford University Press (OUP), 2019.

Abstract

Background The high cost and insufficient supply of human papillomavirus (HPV) vaccines have slowed the pace of controlling cervical cancer. A phase III clinical trial was conducted to evaluate the efficacy, safety, and immunogenicity of a novel Escherichia coli-produced bivalent HPV-16/18 vaccine. Methods A multicenter, randomized, double-blind trial started on November 22, 2012 in China. In total, 7372 eligible women aged 18–45 years were age-stratified and randomly assigned to receive three doses of the test or control (hepatitis E) vaccine at months 0, 1, and 6. Co-primary endpoints included high-grade genital lesions and persistent infection (over 6 months) associated with HPV-16/18. The primary analysis was performed on a per-protocol susceptible population of individuals who were negative for relevant HPV type-specific neutralizing antibodies (at day 0) and DNA (at day 0 through month 7) and who received three doses of the vaccine. This report presents data from a prespecified interim analysis used for regulatory submission. Results In the per-protocol cohort, the efficacies against high-grade genital lesions and persistent infection were 100.0% (95% confidence interval = 55.6% to 100.0%, 0 of 3306 in the vaccine group vs 10 of 3296 in the control group) and 97.8% (95% confidence interval = 87.1% to 99.9%, 1 of 3240 vs 45 of 3246), respectively. The side effects were mild. No vaccine-related serious adverse events were noted. Robust antibody responses for both types were induced and persisted for at least 42 months. Conclusions The E coli-produced HPV-16/18 vaccine is well tolerated and highly efficacious against HPV-16/18–associated high-grade genital lesions and persistent infection in women.

Details

ISSN :
14602105 and 00278874
Volume :
112
Database :
OpenAIRE
Journal :
JNCI: Journal of the National Cancer Institute
Accession number :
edsair.doi.dedup.....a71e7dd2131e7591bb281d5f6ad04e04