Efficacy, Safety, and Immunogenicity of an Escherichia coli-Produced Bivalent Human Papillomavirus Vaccine: An Interim Analysis of a Randomized Clinical Trial. (14th May 2019)

• Record Type: Journal Article
• Authors: Qiao, You-Lin; Wu, Ting; Li, Rong-Cheng; Hu, Yue-Mei; Wei, Li-Hui; Li, Chang-Gui; Chen, Wen; Huang, Shou-Jie; Zhao, Fang-Hui; Li, Ming-Qiang; Pan, Qin-Jing; Zhang, Xun; Li, Qing; Hong, Ying; Zhao, Chao; Zhang, Wen-Hua; Li, Yan-Ping; Chu, Kai; Li, Mei; Jiang, Yun-Fei; Li, Juan; Zhao, Hui; Lin, Zhi-Jie; Cui, Xue-Lian; Liu, Wen-Yu; Li, Cai-Hong; Guo, Dong-Ping; Ke, Li-Dong; Wu, Xin; Tang, Jie; Gao, Guo-Qi; Li, Ba-Yi; Zhao, Bin; Zheng, Feng-Xian; Dai, Cui-Hong; Guo, Meng; Zhao, Jun; Su, Ying-Ying; Wang, Jun-Zhi; Zhu, Feng-Cai; Li, Shao-Wei; Pan, Hui-Rong; Li, Yi-Min; Zhang, Jun; Xia, Ning-Shao;
• Is Part Of: Journal of the National Cancer Institute. Volume 112:Number 2(2020)
• Page Start: 145
• Page End: 153
• Publication Date: 2019-05-14
• Subjects: Cancer -- Periodicals; Cancer -- Research -- Periodicals; 616.994
• DOI: 10.1093/jnci/djz074
• Languages: English
• ISSNs: 0027-8874

Abstract

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.