NCT04969445

The Durability of Protection Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female

The Durability of Protection 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: 647 (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 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 on Hebei Province before and to evaluate the durability of protection 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: 2021-03-30
• Primary completion: 2023-07-27
• Completion: 2024-01-01
• First posted: 2021-07-20
• Last updated: 2023-01-26

Locations

1 site across 1 country: China