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ENROLLING BY INVITATION
NCT07833852

Long-Term Immune Persistence After Bivalent HPV Vaccination in Females From Study 311-HPV-1005

Sponsor: Shanghai Zerun Biotechnology Co.,Ltd

View on ClinicalTrials.gov

Summary

This is a single-center, open-label, prospective observational extension of Study 311-HPV-1005 (NCT04965350). The study follows females who received at least one dose of a bivalent human papillomavirus vaccine containing HPV-16 and HPV-18 L1 virus-like particles in the base study. No vaccine is administered in this extension. Participants in the immunogenicity persistence subset provide blood samples at Months 42 and 66 after the first dose in the base study for measurement of HPV-16 and HPV-18 neutralizing antibodies. Participants eligible for the breakthrough-case cohort are followed for HPV-related cervical disease, including HPV-16- or HPV-18-related cervical intraepithelial neoplasia grade 2 or worse.

Official title: A Single-Center, Open-Label, Long-Term Extension Study to Evaluate Immune Persistence Following Vaccination With a Bivalent Human Papillomavirus Vaccine (Pichia Pastoris) in Healthy Females Aged 9 to 30 Years at Enrollment in Study 311-HPV-1005

Key Details

Gender

FEMALE

Age Range

12 Years - 34 Years

Study Type

OBSERVATIONAL

Enrollment

486

Start Date

2024-08-30

Completion Date

2027-12

Last Updated

2026-09-22

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Pichia pastoris)

Historical exposure assigned in the base study: three intramuscular 0.5-mL doses at Months 0, 2, and 6.

BIOLOGICAL

Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Pichia pastoris)

Historical exposure assigned in the base study: three intramuscular 0.5-mL doses at Months 0, 2, and 6.

Locations (1)

Mianyang Center for Disease Control and Prevention

Mianyang, Sichuan, China