Evaluating HPV vaccination after treatment for cervical lesions
Phase 2 Clinical Trial Evaluating Secondary HPV Vaccination After Treatment of High-grade Cervical Lesions (HPV2-2303)
This study is testing whether giving the HPV vaccine to women over 45 who have been treated for cervical lesions can help clear the virus and prevent future health issues.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 45 Years and up |
| Sex | Female |
| Sponsor | Centre Oscar Lambret Academic / other |
| Locations | 1 site (Lille) |
| Trial ID | NCT06658405 on ClinicalTrials.gov |
What this trial studies
This Phase II interventional study focuses on women over 45 years old who are chronic HPV carriers and have been treated for high-grade cervical lesions. Participants will receive HPV vaccination to assess the rate of HPV clearance within two years following treatment. The study includes a vaccinated cohort receiving the HPV vaccine and a non-vaccinated observational cohort for comparison. Key objectives include evaluating the safety of the vaccine, the incidence of recurrence of cervical lesions, and the potential development of invasive gynecological cancers.
Who should consider this trial
Good fit: Ideal candidates are women over 45 years old who have been treated for high-grade cervical lesions and are chronic HPV carriers.
Not a fit: Patients who are not chronic HPV carriers or those who have contraindications to HPV vaccination may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance HPV clearance rates and reduce the risk of cervical cancer in older women.
How similar studies have performed: While similar studies have explored HPV vaccination, this specific approach targeting older women with a history of high-grade lesions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lille
- Centre Oscar Lambret — Lille, France (Recruiting)
Study contacts
- Study coordinator: Emilie HEYMAN-DECOUPIGNY
- Email: promotion@o-lambret.fr
- Phone: 0320295918
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.