Details

Autor(en) / Beteiligte

• 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

Titel

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

Ist Teil von

• JNCI : Journal of the National Cancer Institute, 2020-02, Vol.112 (2), p.145-153

Ort / Verlag

United States: Oxford University Press

Erscheinungsjahr

2020

Link zum Volltext

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• 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.