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

Summary

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

Timeline

Start

2019-01-03

Primary completion

2019-08-18

Completion

2021-04-01

Publications

• Chu K, Bi ZF, Huang WJ, Li YF, Zhang L, Yang CL, Jiang HM, Zang X, Chen Q, Liu DL, Pan HX, Huang Y, Zheng FZ, Zhang QF, Sun G, Su YY, Huang SJ, Pan HR, Wu T, Hu YM, Zhang J, Zhu FC, Xia NS. Safety and immunogenicity of an Escherichia coli-produced 9-valent human papillomavirus L1 virus-like particle vaccine (types 6/11/16/18/31/33/45/52/58) in healthy adults: an open-label, dose-escalation phase 1 clinical trial. Lancet Reg Health West Pac. 2023 Mar 13;34:100731. doi: 10.1016/j.lanwpc.2023.100731. eCollection 2023 May.

Drugs

Indications