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Long-term Immune Persistence of a Bivalent HPV Vaccine in Females From Study 311-HPV-1004
Sponsor: Shanghai Zerun Biotechnology Co.,Ltd
Summary
This long-term extension study evaluates the persistence of neutralizing antibody responses to a bivalent human papillomavirus vaccine in females who previously participated in study 311-HPV-1004 (NCT02740777). Participants belonged to one of three vaccination cohorts in the base study: adolescents who received two doses at Months 0 and 6, adolescents who received three doses at Months 0, 2, and 6, and adults who received three doses at Months 0, 2, and 6. No vaccine is administered in the extension study. Blood samples are collected at Months 84, 108, and 132 after the first dose in the base study and tested for HPV-16 and HPV-18 neutralizing antibodies using a high-throughput pseudovirus-based neutralization assay.
Official title: An Open-label, Long-term Extension Study to Evaluate the Persistence of Immune Responses to a Bivalent Human Papillomavirus Vaccine (Pichia Pastoris) in Healthy Females Who Were Aged 9 to 26 Years at Enrollment in Study 311-HPV-1004
Key Details
Gender
FEMALE
Age Range
16 Years - 34 Years
Study Type
OBSERVATIONAL
Enrollment
348
Start Date
2023-03-25
Completion Date
2027-12
Last Updated
2026-09-17
Healthy Volunteers
Yes
Conditions
Interventions
Bivalent Human Papillomavirus Vaccine (Types 16 and 18, Pichia pastoris)
Each 0.5 mL dose contained 40 micrograms of HPV-16 L1 virus-like particles and 20 micrograms of HPV-18 L1 virus-like particles adsorbed to aluminum phosphate. The vaccine was administered only in the base study 311-HPV-1004; no study vaccine is administered in 311-HPV-1004-EXTEND.
Locations (2)
Hezhou Center for Disease Control and Prevention
Hezhou, Guangxi, China
Zhongshan County Center for Disease Control and Prevention
Hezhou, Guangxi, China