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Clinical Trials in France / NCT06658405
Recruiting Phase 2

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

NCT06658405 · tracked via the Priya Life Science France tracker
Sponsor
Centre Oscar Lambret
Phase
Phase 2
Started
2025-01-13
Last updated
2026-03-18

Condition(s) studied

Cervical Lesion

Investigational drug(s) / intervention(s)

Human Papillomavirus 9-valent Vaccine, Recombinant →

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.

Study 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
FEMALE
Min age
45 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Common eligibility criteria for the study (for both cohorts) : 1. Female patient over 45 years old 2. Patient treated by conization for high-grade cervical epithelial lesion 3. Positive HPV test at the 6-month post-operative control (a delay of 6 to 12 months will be accepted), leading to an indication for a control colposcopy (+/- biopsy) according to standard surveillance practices. 4. N.B. : Patients with abnormalities at the initial control colposcopy and/or positive biopsy remain eligible for the study, whether vaccinated or not. 2. Additional eligibility criteria for the clinical trial (Vaccinated patients cohort) 1. No contraindication to HPV vaccination with Gardasil 9 2. Patient consented to HPV vaccination with Gardasil 9 3. Affiliated with a social security system 4. Informed and signed written consent provided 5. N.B. : Patients infected with HIV are eligible for the vaccine trial provided they are on antiretroviral therapy. 3. Inclusion criteria for the data study (Non-vaccinated patients cohort) 1. Patient eligible for the study (a) and not eligible for the clinical trial (b) due to: * refusal of vaccination, or * A contraindication to vaccination 2. No objection to the use of their personal data for research purposes N.B. : A patient who initially refused vaccination may later request to be vaccinated as part of the trial after signing the consent form. The vaccine trial analysis will include all patients who started vaccination within 6 months after the initial HPV control test. Exclusion Criteria: 1. Common exclusion criteria for the study (for both cohorts) 1. History of primary HPV vaccination 2. History of HPV-induced invasive cancer (cervical, vaginal, vulvar, anal, oropharyngeal cancer) 2. Exclusion criteria for the clinical trial (Vaccinated patients cohort) 1. Patient refusing HPV vaccination 2. Patient with a contraindication to HPV vaccination with Gardasil 9 3. Patient deprived of liberty or under guardianship 3. Exclusion criteria for the data study (Non-vaccinated patients cohort) a) Opposition to the use of their personal data for research purposes

Primary outcome measure(s)

  • Proportion of HPV-negative status — Within 2 years after the initial HPV control test
    The primary outcome is to estimate the proportion of HPV-negativation status within two years of the initial positive HPV control test. Negativation is defined as a negative HPV test result. If the patient cannot be evaluated due to the occurrence of cancer, this will be considered a failure (equivalent to absence of negativation).

Trial sites (1)

FacilityCityRegionStatus
Centre Oscar Lambret Lille France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06658405 on ClinicalTrials.gov ↗ ← All trials in France