Clinical trial NCT06658405: Clinical Trial Evaluating Secondary HPV Vaccination After Treatment of High-grade Cervical Lesions (HPV2-2303)
Official title: Phase 2 Clinical Trial Evaluating Secondary HPV Vaccination After Treatment of High-grade Cervical Lesions (HPV2-2303)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cervical Lesion
Keywords: HPV
oncology
secondary prevention
cervix
vaccination
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Canceropôle Nord Ouest
First posted: 2024-10-26
Enrollment: 85
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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..
Primary purpose: PREVENTION

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. 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).

Eligibility criteria: 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 outcomes:
measure: Proportion of HPV-negative status
timeFrame: Within 2 years after the initial HPV control test
Secondary outcomes:
measure: Dynamics of HPV viral clearance
timeFrame: every 12 months for up to 5 years
measure: Adverse Events
timeFrame: Throughout the vaccination schedule plus 30 days
measure: Incidence of high-grade intraepithelial lesions
timeFrame: From the initial HPV control test up to the first recurrence event up to 5 years
measure: Incidence of invasive gynecological cancer
timeFrame: From the initial HPV control test to the occurrence of invasive cancer up to 5 years
measure: Compliance with vaccination schedule
timeFrame: Throughout the vaccination period (up to 1 year)
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Centre Oscar Lambret
name: Nora ALLOY, MD
role: STUDY_DIRECTOR
References: