Clinical trial · Observational
Long-term Immune Persistence of a Bivalent HPV Vaccine in Females From Study 311-HPV-1004
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bivalent Human Papillomavirus Vaccine (Types 16 and 18, Pichia pastoris) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- 2-dose adolescent cohort
- description
- Participants who were aged 9 to 14 years at enrollment in the base study and received the bivalent HPV vaccine at Months 0 and 6. No vaccine is administered in the extension study.
- interventionNames
- Biological: Bivalent Human Papillomavirus Vaccine (Types 16 and 18, Pichia pastoris)
- label
- 3-dose adolescent cohort
- description
- Participants who were aged 9 to 14 years at enrollment in the base study and received the bivalent HPV vaccine at Months 0, 2, and 6. No vaccine is administered in the extension study.
- interventionNames
- Biological: Bivalent Human Papillomavirus Vaccine (Types 16 and 18, Pichia pastoris)
- label
- 3-dose adult cohort
- description
- Participants who were aged 18 to 26 years at enrollment in the base study and received the bivalent HPV vaccine at Months 0, 2, and 6. No vaccine is administered in the extension study.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
- Maximum age
- 34 Years
Show eligibility criteria text
Inclusion Criteria: * The participant, and the participant's legal guardian when applicable, is able to understand the study information and voluntarily sign the informed consent form for the extension study. * In the investigator's judgment, the participant is able to comply with protocol requirements, including attending scheduled visits and responding to follow-up telephone contacts. * The participant was enrolled in study 311-HPV-1004 and completed blood collection at Day 0 and Months 7, 12, 24, and 36. Exclusion Criteria: * Receipt of any HPV vaccine other than the study vaccine during study 311-HPV-1004 or between completion of that study and enrollment in this extension study. * Use of an investigational or unregistered product, other than the study vaccine, during study 311-HPV-1004 or between completion of that study and enrollment in this extension study. * Seropositivity for both HPV-16 and HPV-18 antibodies at baseline in study 311-HPV-1004. * Long-term use of immunosuppressive agents or
References
Publications (1)
- BACKGROUNDLi J, Shi LW, Li K, Huang LR, Li JB, Dong YL, Li W, Ji M, Yang Q, Zhou LY, Yuan L, Yan XM, Chen JJ, Jiang ZW, Qi YY, Li RC, Li YP, Xia JL, Yu BW, Mo ZJ, Li CG. Comparison of the safety and persistence of immunogenicity of bivalent HPV16/18 vaccine in healthy 9-14-year-old and 18-26-year-old Chinese females: A randomized, double-blind, non-inferiority clinical trial. Vaccine. 2023 Oct 26;41(48):7212-9. doi: 10.1016/j.vaccine.2023.10.041. Online ahead of print. PMID 39492306