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

NCT06658405 | Recruiting Phase 2

• 2 other identifiers: HPV2-23032024-513081-19-00
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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. 1.Eligible patients who consent to vaccination will participate in a prospective, single-center, single-arm, interventional clinical trial (Category 2).
2. 2.Non-vaccinated patients will be included in a non-interventional observational study, with no changes to their standard care.

Conditions

Cervical Lesion

Keywords

HPV; oncology; secondary prevention; cervix; vaccination

Outcome Measures

Primary Outcomes (1)

• Proportion of HPV-negative status

  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).

  Within 2 years after the initial HPV control test

Secondary Outcomes (5)

• Dynamics of HPV viral clearance

  every 12 months for up to 5 years

• Adverse Events

  Throughout the vaccination schedule plus 30 days

• Incidence of high-grade intraepithelial lesions

  From the initial HPV control test up to the first recurrence event up to 5 years

• Incidence of invasive gynecological cancer

  From the initial HPV control test to the occurrence of invasive cancer up to 5 years

• Compliance with vaccination schedule

  Throughout the vaccination period (up to 1 year)

Study Arms (2)

Vaccinated patients

EXPERIMENTAL

Human papillomavirus vaccine, nonvalent, Gardasil 9

Biological: Human Papillomavirus 9-valent Vaccine, Recombinant

Non-vaccinated patients

NO INTERVENTION

no changes to standard care

Interventions

Human Papillomavirus 9-valent Vaccine, Recombinant BIOLOGICAL

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.

Also known as: Gardasil 9

Vaccinated patients

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Women with chronic HPV infections, particularly those who have undergone treatment for high-grade cervical lesions.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Common eligibility criteria for the study (for both cohorts) :
• Female patient over 45 years old
• Patient treated by conization for high-grade cervical epithelial lesion
• 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.
• N.B. : Patients with abnormalities at the initial control colposcopy and/or positive biopsy remain eligible for the study, whether vaccinated or not.
• Additional eligibility criteria for the clinical trial (Vaccinated patients cohort)
• No contraindication to HPV vaccination with Gardasil 9
• Patient consented to HPV vaccination with Gardasil 9
• Affiliated with a social security system
• Informed and signed written consent provided
• N.B. : Patients infected with HIV are eligible for the vaccine trial provided they are on antiretroviral therapy.
• Patient eligible for the study (a) and not eligible for the clinical trial (b) due to:
• refusal of vaccination, or
• A contraindication to vaccination
• No objection to the use of their personal data for research purposes

You may not qualify if:

• History of primary HPV vaccination
• History of HPV-induced invasive cancer (cervical, vaginal, vulvar, anal, oropharyngeal cancer)
• Patient refusing HPV vaccination
• Patient with a contraindication to HPV vaccination with Gardasil 9
• Patient deprived of liberty or under guardianship

Sponsors & Collaborators

• Centre Oscar Lambret: lead
• Canceropôle Nord Ouest: collaborator

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Human Papillomavirus Recombinant Vaccine nonavalent

Study Officials

• Nora ALLOY, MD

  Centre Oscar Lambret

  STUDY DIRECTOR

Central Study Contacts

Emilie HEYMAN-DECOUPIGNY

CONTACT

0320295918; promotion@o-lambret.fr

Hugo JOSE

CONTACT

0320295918; promotion@o-lambret.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study uses a non-randomized design with two cohorts: vaccinated patients in a single-arm clinical trial and non-vaccinated patients in an observational study, chosen to reflect real-life scenarios and ensure comprehensive data collection despite the absence of randomization..

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 26, 2024
• Study Start: January 13, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 31, 2031
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)