RecruitingPhase 2NCT06658405

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)


Sponsor

Centre Oscar Lambret

Enrollment

85 participants

Start Date

Jan 13, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether getting the HPV vaccine (Gardasil 9) after treatment for a high-grade precancerous cervical lesion can reduce the chance of the abnormal cells coming back, especially in women over 45 who still test positive for HPV after their procedure. **You may be eligible if...** - You are a woman over 45 years old - You previously had treatment (called a conization) for a high-grade abnormal cervical finding - You tested positive for HPV at your 6-month follow-up appointment - You are willing to receive the HPV vaccine (Gardasil 9) - If you have HIV, you are on antiretroviral therapy **You may NOT be eligible if...** - You have an allergy or contraindication to the HPV vaccine - You are unwilling to be vaccinated (you may still be eligible for a data-only arm of the study) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALHuman 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.


Locations(1)

Centre Oscar Lambret

Lille, France

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NCT06658405


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