drugset / Trial / NCT06658405

Clinical Trial Evaluating Secondary HPV Vaccination After Treatment of High-grade Cervical Lesions

NCT06658405

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

EvaluationDrugModalityDoseRoute
Subject Gardasil 9 Vaccine

Indications