drugset / Trial / NCT06658405
Clinical Trial Evaluating Secondary HPV Vaccination After Treatment of High-grade Cervical Lesions
Non-randomizedParallel-groupOpen-labelPrevention
Summary
This is a single-center, Phase II interventional study evaluating secondary HPV vaccination after treatment of high-grade cervical lesions. The study aims to estimate the rate of HPV clearance within two years following an initial positive HPV control test in women over 45 years of age who are chronic HPV carriers and have undergone treatment for high-grade intraepithelial cervical lesions, and who receive HPV vaccination. The study includes two cohorts: 1. Eligible patients who consent to vaccination will participate in a prospective, single-center, single-arm, interventional clinical trial (Category 2). 2. Non-vaccinated patients will be included in a non-interventional observational study, with no changes to their standard care.
Timeline
- Start
- 2025-01-13
- Primary completion
- 2028-10
- Completion
- 2031-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gardasil 9 | Vaccine | — | — |