Clinical trial · Observational
Long-Term Immune Persistence After Bivalent HPV Vaccination in Females From Study 311-HPV-1005
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Pichia pastoris) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Commercial-Scale Vaccine Cohort
- description
- Participants who were assigned in NCT04965350 to receive one of three consecutive commercial-scale lots of the bivalent HPV vaccine on a 0-, 2-, and 6-month schedule. No vaccine is administered in the extension study.
- interventionNames
- Biological: Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Pichia pastoris)
- label
- Clinical-Scale Vaccine Cohort
- description
- Participants who were assigned in NCT04965350 to receive the clinical-scale lot of the bivalent HPV vaccine on a 0-, 2-, and 6-month schedule. No vaccine is administered in the extension study.
- interventionNames
- Biological: Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Pichia pastoris)
Primary outcomes (4)
- measure
- Geometric Mean Titer of Neutralizing Antibodies Against HPV-16
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 12 Years
- Maximum age
- 34 Years
Show eligibility criteria text
Inclusion Criteria: * Previously enrolled in Study 311-HPV-1005 (NCT04965350) at the Mianyang Center for Disease Control and Prevention. * Received at least one dose of the bivalent HPV vaccine in the base study. * For the immunogenicity persistence subset: completed all three doses in the base study and had valid neutralizing antibody results before vaccination and one month after the third dose. * For the breakthrough-case cohort: at least 18 years of age at extension-study enrollment or becoming 18 years of age during the extension study. * Participant provided written informed consent; for a participant younger than 18 years at extension-study enrollment, the participant and at least one parent or legal guardian provided written informed consent or assent as required. * Able to understand and comply with the study procedures. Participants in the immunogenicity persistence subset agreed to blood collection at Months 42 and 66. Participants in the breakthrough-case cohort agreed to scheduled remote or site follow-up and to provide relevant HPV- and cervical-disease information. Exclusion Criteria: * Receipt of any other HPV vaccine during Study 311-HPV-1005 or between completion of the base study and enrollment in this extension. * At a visit involving blood collection, any condition that may interfere with venipuncture, including a platelet count below 20 x 10\^9/L, phlebitis, or hemophilia. * Any other factor that, in the investigator's judgment, makes the participant unsuitable for the study.
References
Publications (0)
Data not yet available