NCT06658405

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

Phase 2 Clinical Trial Evaluating Secondary HPV Vaccination After Treatment of High-grade Cervical Lesions (HPV2-2303)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The aim of this study is to estimate the proportion of HPV clearance within two years following an initial positive HPV control test in women over 45 years old who are chronic HPV carriers and have undergone treatment for high-grade intraepithelial cervical lesions. These women will receive HPV vaccination as part of the study. Other objectives of the study include: 1. Describing the dynamics of viral clearance in chronic HPV carriers who receive HPV vaccination. 2. Evaluating the safety of HPV vaccination. 3. Estimating the incidence of recurrence of high-grade intraepithelial cervical lesions in chronic HPV carriers after surgical treatment of the initial lesion and HPV vaccination. 4. Estimating the incidence of invasive gynecological cancers (cervical, vaginal, or vulvar) in chronic HPV carriers after surgical treatment of the initial lesion and HPV vaccination. 5. Identifying factors associated with the refusal of HPV vaccination, such as smoking, parity, body mass index, employment status, education level, family history, and marital status. 6. Describing compliance with the proposed vaccination schedule in terms of: 1. Number of injections completed. 2. Adherence to the timing of injections. 7. Evaluating the effect of vaccination on: 1. HPV clearance within two years. 2. The dynamics of viral clearance. 3. The risk of recurrence of high-grade intraepithelial lesions. 4. The risk of developing invasive gynecological cancers (cervical, vaginal, or vulvar). by comparing vaccinated patients included in the clinical trial with the cohort of non-vaccinated patients (those who refused HPV vaccination or for other reasons).

Conditions

• Cervical Lesion

Interventions

Type	Name	Description
BIOLOGICAL	Human Papillomavirus 9-valent Vaccine, Recombinant	HPV vaccine administered in three doses: first dose on day 1, second dose 2 months later, and third dose 4 months after the second dose, within a one-year period.

Timeline

• Start date: 2025-01-13
• Primary completion: 2028-10-01
• Completion: 2031-12-31
• First posted: 2024-10-26
• Last updated: 2026-03-18

Locations

1 site across 1 country: France