A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine

Summary

This trail is to evaluate the safety profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in healthy Chinese women ages 20-45 and determine the optimal ratio of the antigens included in the investigational vaccine. Besides, the trail is also to demonstrate that the levels of neutralizing antibodies to vaccine HPV types 31, 33, 45, 52 and 58 elicited by the investigational vaccine with the chosen optimal antigen ratio are superior to those induced by Gardasil.

Timeline

Start

2020-05-23

Primary completion

2020-12-11

Completion

2021-01-27

Publications

• Wei M, Liu H, Yu H, Pan H, Tao H, Zhang J, Han W, Wu D, Wang W, Li J. Immunogenicity and safety of an Escherichia coli-produced 9-valent human papillomavirus vaccine (types 6/11/16/18/31/33/45/52/58) in healthy Chinese women aged 20-45 years: a single-center, randomized, observer-blinded, positive controlled phase 2 clinical trial. Front Immunol. 2025 Nov 14;16:1706662. doi: 10.3389/fimmu.2025.1706662. eCollection 2025.

Drugs

Indications