NCT05045755

The Durability of Protection and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female

The Durability of Protection and Immuno-persistence Study of A Bivalent Human Papillomavirus (Type 16, 18) Recombinant Vaccine (E.Coli) in Healthy Women Aged 18 to 45 Years

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,339 (estimated)
• Sponsor: Jun Zhang · Academic / Other
• Sex: Female
• Age: 26 Years – 54 Years
• Healthy volunteers: —

Summary

The primary objective of this study is to evaluate the durability of protection and immuno-persistence of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine administered in females aged 18-45 years.

Detailed description

This is a follow-up study that is based on phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females aged 18-45 years (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006). The investigators will recruit people who have participated in phase III clinical study before and to evaluate the durability of protection and immuno-persistence of the bivalent HPV vaccine on 90m and 114m after dose 1.

Conditions

• Cervical Intraepithelial Neoplasia
• Cervical Cancer
• Vaginal Intraepithelial Neoplasia
• Vulvar Intraepithelial Neoplasia
• Persistent Infection

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)	The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with 208 μg of aluminum adjuvant

Timeline

• Start date: 2021-04-13
• Primary completion: 2023-08-10
• Completion: 2024-01-01
• First posted: 2021-09-16
• Last updated: 2023-01-26

Locations

1 site across 1 country: China