Can a vaccine clear HPV after cervical lesion surgery?
NCT ID NCT06658405
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether giving the HPV vaccine to women over 45 who still have the virus after treatment for high-grade cervical lesions can help clear the virus faster. About 85 women will either get the vaccine or be observed without it. The goal is to see if the vaccine increases the chance of a negative HPV test within two years.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 85 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre Oscar Lambret
RECRUITINGLille, 59020, France
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