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已发表论文
基于国家药品监督管理局数据库的中国预防人乳头瘤病毒（HPV）疫苗临床试验的景观分析
Authors He G , Huang Y, Zhang X, Yuan L, Jiang H, Hong L, Zeng T
Received 25 August 2025
Accepted for publication 29 November 2025
Published 16 December 2025 Volume 2025:19 Pages 11245—11257
DOI https://doi.org/10.2147/DDDT.S562608
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 4
Editor who approved publication: Professor Yan Zhu
Gaoli He,* Yanmei Huang,* Xiaoyan Zhang, Lanfang Yuan, Hua Jiang, Lu Hong, Tao Zeng
Office of Clinical Trial Institution, Obstetrics & Gynecology Hospital of Fudan University, Shanghai Key Laboratory of Reproduction and Development, Shanghai Key Laboratory of Female Reproductive Endocrine Related Diseases, Shanghai, 200433, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Tao Zeng, Office of Clinical Trial Institution, Obstetrics & Gynecology Hospital of Fudan University, Shanghai Key Laboratory of Reproduction and Development, Shanghai Key Laboratory of Female Reproductive Endocrine Related Diseases, Shanghai, 200433, People’s Republic of China, Tel +86 21 63453967, Email zengtao1283@163.com Lu Hong, Office of Clinical Trial Institution, Obstetrics & Gynecology Hospital of Fudan University, Shanghai Key Laboratory of Reproduction and Development, Shanghai Key Laboratory of Female Reproductive Endocrine Related Diseases, Shanghai, 200433, People’s Republic of China, Tel +86 21 63453967, Email honglu7732@fckyy.org.cn
Purpose: Human papillomavirus (HPV) vaccination is key to preventing cervical cancer, and increasing its coverage in China faces complex challenges. Comprehensive literature providing an overview of the current status of HPV vaccine clinical trials in China remains lacking. To address this gap, our study was the first to systematically analyze and summarize the characteristics of HPV prophylactic vaccines clinical trials in China over a decade, providing a reference for HPV vaccine research and development.
Methods: We analyzed HPV prophylactic vaccine clinical trials registered on the Chinese National Medical Products Administration (NMPA) Registration and Information Disclosure Platform (http://www.chinadrugtrials.org.cn) from January 1, 2013, to December 31, 2024.
Results: Eighty registered trials were evaluated, of which 51 trials (63.75%) were ongoing, 27 were completed (33.75%) and 2 were terminated (2.50%). The top three vaccine types by proportion were nonavalent vaccines (38.75%, n=31), followed by bivalent (35.00%, n=28) and quadrivalent (12.50%, n=10) vaccines. Domestic enterprises sponsored most trials (81.25%, n=65). The leading research sites were located mainly in the eastern and western China. Only 31.25% (n=25) of the trials had a data monitoring safety committee, and 43.75% (n=35) had clinical trial insurance. Most trials were in Phase III, with a randomized, double-blind, parallel-group design, and most (82.5%, n=66) enrolled female participants. Domestic vs overseas enterprises differed significantly in terms of phase (p = 0.010), intervention (p = 0.000), allocation (p = 0.016), masking (p = 0.002), leading research site region (p = 0.016)/type (p = 0.002), and insurance (p = 0.019).
Conclusion: HPV vaccine clinical trials in China have made significant progress, with most at a crucial stage, featuring diverse vaccine types and high-quality designs. However, more efforts are needed to promote the development and approval of the HPV vaccine by increasing tertiary hospitals’ qualifications for conducting clinical trials, establishing a government-led non-profit third-party quality control platform and increasing research and development investment to ensure insurance coverage.
Keywords: HPV prophylactic vaccine, HPV vaccination, clinical trials, NMPA registration and information disclosure platform, pharmaceutical company
Office of Clinical Trial Institution, Obstetrics & Gynecology Hospital of Fudan University, Shanghai Key Laboratory of Reproduction and Development, Shanghai Key Laboratory of Female Reproductive Endocrine Related Diseases, Shanghai, 200433, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Tao Zeng, Office of Clinical Trial Institution, Obstetrics & Gynecology Hospital of Fudan University, Shanghai Key Laboratory of Reproduction and Development, Shanghai Key Laboratory of Female Reproductive Endocrine Related Diseases, Shanghai, 200433, People’s Republic of China, Tel +86 21 63453967, Email zengtao1283@163.com Lu Hong, Office of Clinical Trial Institution, Obstetrics & Gynecology Hospital of Fudan University, Shanghai Key Laboratory of Reproduction and Development, Shanghai Key Laboratory of Female Reproductive Endocrine Related Diseases, Shanghai, 200433, People’s Republic of China, Tel +86 21 63453967, Email honglu7732@fckyy.org.cn
Purpose: Human papillomavirus (HPV) vaccination is key to preventing cervical cancer, and increasing its coverage in China faces complex challenges. Comprehensive literature providing an overview of the current status of HPV vaccine clinical trials in China remains lacking. To address this gap, our study was the first to systematically analyze and summarize the characteristics of HPV prophylactic vaccines clinical trials in China over a decade, providing a reference for HPV vaccine research and development.
Methods: We analyzed HPV prophylactic vaccine clinical trials registered on the Chinese National Medical Products Administration (NMPA) Registration and Information Disclosure Platform (http://www.chinadrugtrials.org.cn) from January 1, 2013, to December 31, 2024.
Results: Eighty registered trials were evaluated, of which 51 trials (63.75%) were ongoing, 27 were completed (33.75%) and 2 were terminated (2.50%). The top three vaccine types by proportion were nonavalent vaccines (38.75%, n=31), followed by bivalent (35.00%, n=28) and quadrivalent (12.50%, n=10) vaccines. Domestic enterprises sponsored most trials (81.25%, n=65). The leading research sites were located mainly in the eastern and western China. Only 31.25% (n=25) of the trials had a data monitoring safety committee, and 43.75% (n=35) had clinical trial insurance. Most trials were in Phase III, with a randomized, double-blind, parallel-group design, and most (82.5%, n=66) enrolled female participants. Domestic vs overseas enterprises differed significantly in terms of phase (p = 0.010), intervention (p = 0.000), allocation (p = 0.016), masking (p = 0.002), leading research site region (p = 0.016)/type (p = 0.002), and insurance (p = 0.019).
Conclusion: HPV vaccine clinical trials in China have made significant progress, with most at a crucial stage, featuring diverse vaccine types and high-quality designs. However, more efforts are needed to promote the development and approval of the HPV vaccine by increasing tertiary hospitals’ qualifications for conducting clinical trials, establishing a government-led non-profit third-party quality control platform and increasing research and development investment to ensure insurance coverage.
Keywords: HPV prophylactic vaccine, HPV vaccination, clinical trials, NMPA registration and information disclosure platform, pharmaceutical company