Efficacy, Immunogenicity and Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)

Summary

This phase III clinical study was designed to evaluate the efficacy,immunogenicity and safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli) manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women aged 18-45 years old.

Timeline

Start

2020-09-05

Primary completion

2027-12-31

Completion

2027-12-31

Outcome

Met primary endpoint

paper In the per-protocol set, antibody responses against HPV 16 and 18 in the vaccine group were non-inferior to those in the control group. PMID 42379209 ↗

Publications

• Pan HX, Bi ZF, Jing YL, Hu SY, Zhang L, Zhu KX, Chu K, Hong Y, Chang SF, Pan QJ, Zhang X, Xu JB, Tang J, Yuan DY, Jiang H, Du C, Sun G, Zhong GH, Chen Q, Wei LH, Qiao YL, Li SW, Su YY, Zhang QF, Huang SJ, Zhao FH, Huang WJ, Wu T, Zhang J, Xia NS. Efficacy, safety, and immunogenicity of an Escherichia coli-produced nine-valent human papillomavirus vaccine: a multicentre, double-blind, randomised, controlled, phase 3 trial. Lancet Infect Dis. 2026 Jun 30:S1473-3099(26)00221-5. doi: 10.1016/S1473-3099(26)00221-5. Online ahead of print.

Drugs

Indications