MedTrace Logo

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

NCT06658405 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2026-03-18

No results posted yet for this 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.

Conditions

  • Cervical Lesion

Interventions

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.

Sponsors & Collaborators

  • Canceropôle Nord Ouest

    collaborator OTHER

  • Centre Oscar Lambret

    lead OTHER

Principal Investigators

  • Nora ALLOY, MD · Centre Oscar Lambret

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-13
Primary Completion
2028-10-31
Completion
2031-12-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06658405 on ClinicalTrials.gov