Clinical Trial Evaluating Secondary HPV Vaccination After Treatment of High-grade Cervical Lesions
ConditionCervical Lesion
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age45+
SponsorCentre Oscar Lambret
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Common exclusion criteria for the study (for both cohorts)
History of primary HPV vaccination
History of HPV-induced invasive cancer (cervical, vaginal, vulvar, anal, oropharyngeal cancer)
Exclusion criteria for the clinical trial (Vaccinated patients cohort)
Trial design
Treatments tested in this trial
- Human Papillomavirus 9-valent Vaccine, Recombinant
Treatment groups
85 Participants
are divided into 2 treatment groupsSponsors and collaborators
Centre Oscar Lambret
Lead sponsor
Canceropôle Nord Ouest
Collaborator
Source ClinicalTrials.gov