A Phase III Study of Human Papillomavirus (HPV)-16/18 Vaccine.

Summary

A Phase III Double Blinded, Randomized Controlled Study to Evaluate Efficacy of Protection Against HPV-16 and 18 Related Diseases, Immunogenicity and Safety of Recombinant Human Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Healthy Females Aged 18-30 Years.

Timeline

Start

2014-11-02

Primary completion

2019-07-30

Completion

2020-01-16

Outcome

Met primary endpoint

paper corresponding to vaccine efficacy of 78.6% (95% CI 23.3-96.1; p = 0.012). PMID 41413453 ↗

Publications

• Shi L, Gao X, Huang L, Gao Z, Li J, Yu B, Fan H, Li G, Wang Y, Li Q, Yuan L, Li C, Mo Z; HPV1003 Study group; Li Shi; Ke Li; Min Ji; Ya-Lin Hu; Ling-Yun Zhou; Xue-Mei Yan; Jing-Jing Chen; Wei Li; Zi-Long Wang; Zhen Huang; Yu-Liang Zhao; Rong-Cheng Li; Yan-Ping Li; Nian-Min Shi; Qiang Lu; Bin He; Shi-Fang Wen; Dong-Zhang Yang; Guo-Gang Liu; Yan-Xia Cai; Wei-Jiang Cui; Jiang-Bing Zheng; Zhan-Bo Geng; Yan-Hua Xie; Yong-Biao Ren; Hai-Song Zhou. Efficacy, safety and immunogenicity of a recombinant human papillomavirus bivalent (types 16, 18) vaccine in healthy 18-30-year-old Chinese women: a phase III, double-blind, randomized, controlled trial. BMC Infect Dis. 2025 Dec 18;26(1):248. doi: 10.1186/s12879-025-12064-1.

Drugs

Indications