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Long-Term Immune Persistence After Bivalent HPV Vaccination in Females From Study 311-HPV-1005
Sponsor: Shanghai Zerun Biotechnology Co.,Ltd
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
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.
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