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- Title
Efficacy, Safety, and Immunogenicity of an Escherichia coli-Produced Bivalent Human Papillomavirus Vaccine: An Interim Analysis of a Randomized Clinical Trial.
- 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
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.
- Subjects
CHINA; HUMAN papillomavirus vaccines; CLINICAL trials; HEPATITIS E; ESCHERICHIA; ANTIBODY formation; PAPILLOMAVIRUSES; RESEARCH; IMMUNIZATION; RESEARCH methodology; EVALUATION research; MEDICAL cooperation; COMPARATIVE studies; RANDOMIZED controlled trials; PAPILLOMAVIRUS diseases; CERVIX uteri tumors
- Publication
JNCI: Journal of the National Cancer Institute, 2020, Vol 112, Issue 2, p145
- ISSN
0027-8874
- Publication type
journal article
- DOI
10.1093/jnci/djz074