Cervical LesionPhase 2HPV2NCT06658405
Clinical Trial Evaluating Secondary HPV Vaccination After Treatment of High-grade Cervical Lesions
A Phase 2 study testing Human Papillomavirus 9-valent Vaccine, Recombinant in people with Cervical Lesion, run by Centre Oscar Lambret at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Cervical Lesion
- What is being tested?
- Human Papillomavirus 9-valent Vaccine, Recombinant
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2025to 31 Dec 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 17Show fewer
- 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.
- Inclusion criteria for the data study (Non-vaccinated patients cohort)
- 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
- 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.
Who cannot join
- 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)
- Patient refusing HPV vaccination
- Patient with a contraindication to HPV vaccination with Gardasil 9
- Patient deprived of liberty or under guardianship
- Exclusion criteria for the data study (Non-vaccinated patients cohort) a) Opposition to the use of their personal data for research purposes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Oscar Lambret
Lille, 59020
Nora ALLOY, MD, 0320295959, n-alloy@o-lambret.fr
Carlos MARTINEZ GOMEZ, MD
About this study
Official title: Phase 2 Clinical Trial Evaluating Secondary HPV Vaccination After Treatment of High-grade Cervical Lesions (HPV2-2303)
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:
- Eligible patients who consent to vaccination will participate in a prospective, single-center, single-arm, interventional clinical trial (Category 2).
- Non-vaccinated patients will be included in a non-interventional observational study, with no changes to their standard care.
Read the 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:
- Describing the dynamics of viral clearance in chronic HPV carriers who receive HPV vaccination.
- Evaluating the safety of HPV vaccination.
- 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.
- 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.
- 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.
- Describing compliance with the proposed vaccination schedule in terms of:
- Number of injections completed.
- Adherence to the timing of injections.
- Evaluating the effect of vaccination on:
- HPV clearance within two years.
- The dynamics of viral clearance.
- The risk of recurrence of high-grade intraepithelial lesions.
- 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).
- Conditions
- Cervical Lesion
- Being tested
- Human Papillomavirus 9-valent Vaccine, Recombinant
- Keywords
- HPV, oncology, secondary prevention, cervix, vaccination
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Papillomavirus 9-valent Vaccine, RecombinantBiological
Also called Gardasil 9
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.
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated patients | Experimental | Human papillomavirus vaccine, nonvalent, Gardasil 9 Receives: Biological: Human Papillomavirus 9-valent Vaccine, Recombinant |
| Non-vaccinated patients | No intervention | no changes to standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 2 years after the initial HPV control test
Secondary outcomes (5)
Dynamics of HPV viral clearance
HPV status over time assessed by smear every 12 months until HPV-negative status (in the study: within 5 years of follow-up). When the test is negative, a follow-up smear is performed three years later (in the study: within 5 years of follow-up)
Measured: every 12 months for up to 5 years
Adverse Events
Adverse events will be recorded and evaluated according to the NCI-CTCAE V5.0 scale. AEs will be documented after each vaccination, during subsequent injections, and through a follow-up phone call 30 days after the third injection. Severe Adverse Events (grade ≥3) will be considered significant.
Measured: Throughout the vaccination schedule plus 30 days
Incidence of high-grade intraepithelial lesions
The time to recurrence of high-grade cervical lesions will be calculated from the date of the initial HPV control test to the first documented event of lesion recurrence, as indicated by clinical follow-up and diagnostic testing.
Measured: From the initial HPV control test up to the first recurrence event up to 5 years
Incidence of invasive gynecological cancer
The incidence of invasive gynecological cancers (cervix, vagina, vulva) will be determined by calculating the time from the initial HPV control test to the first occurrence of HPV-related invasive cancer at any sites (cervix, vagina, vulva)
Measured: From the initial HPV control test to the occurrence of invasive cancer up to 5 years
Compliance with vaccination schedule
Compliance will be measured by the number of vaccine doses received and adherence to the recommended timing between injections, including the interval between the 1st and 3rd doses of Gardasil 9.
Measured: Throughout the vaccination period (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start13 Jan 2025
- Primary completionOct 2028 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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..
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Canceropôle Nord Ouest
- Responsible party
- Sponsor
- Investigators
- Nora ALLOY, MD, Study director, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658405
- Sponsor's protocol ID
- HPV2-2303
- Other IDs
- 2024-513081-19-00
- Acronym
- HPV2
- Status last verified
- Mar 2026
- First submitted
- 22 Oct 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Clinical Trial Evaluating Secondary HPV Vaccination After Treatment of High-grade Cervical Lesions (HPV2-2303)
- ClinicalTrials.gov ID
- NCT06658405
- Acronym / sponsor ID
- HPV2 / HPV2-2303
- Conditions
- Cervical Lesion
- Keywords
- HPV, oncology, secondary prevention, cervix, vaccination
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Canceropôle Nord Ouest
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Eligible patients who consent to vaccination will participate in a prospective, single-center, single-arm, interventional clinical trial (Category 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:
- Describing the dynamics of viral clearance in chronic HPV carriers who receive HPV vaccination.
- Evaluating the safety of HPV vaccination.
- 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.
- 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.
- 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.
- Describing compliance with the proposed vaccination schedule in terms of:
- Number of injections completed.
- Adherence to the timing of injections.
- Evaluating the effect of vaccination on:
- HPV clearance within two years.
- The dynamics of viral clearance.
- The risk of recurrence of high-grade intraepithelial lesions.
- 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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..
| Arm | Type | Receives |
|---|---|---|
| Vaccinated patients | Experimental | Biological: Human Papillomavirus 9-valent Vaccine, RecombinantHuman papillomavirus vaccine, nonvalent, Gardasil 9 |
| Non-vaccinated patients | No intervention | –no changes to standard care |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Common eligibility criteria for the study (for both cohorts) :
- Additional eligibility criteria for the clinical trial (Vaccinated patients cohort)
- Inclusion criteria for the data study (Non-vaccinated patients cohort)
- 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.
Key exclusion criteria (8 listed)
- Common exclusion criteria for the study (for both cohorts)
- Exclusion criteria for the clinical trial (Vaccinated patients cohort)
- Exclusion criteria for the data study (Non-vaccinated patients cohort) a) Opposition to the use of their personal data for research purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Papillomavirus 9-valent Vaccine, RecombinantAlso: Gardasil 9HPV 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. | Biological | Vaccinated patients |
Primary outcome
Proportion of HPV-negative status
Time frame: Within 2 years after the initial HPV control test
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).
5 secondary outcomes
Dynamics of HPV viral clearance
Time frame: every 12 months for up to 5 years
Adverse Events
Time frame: Throughout the vaccination schedule plus 30 days
Incidence of high-grade intraepithelial lesions
Time frame: From the initial HPV control test up to the first recurrence event up to 5 years
Incidence of invasive gynecological cancer
Time frame: From the initial HPV control test to the occurrence of invasive cancer up to 5 years
Compliance with vaccination schedule
Time frame: Throughout the vaccination period (up to 1 year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nora ALLOY, MD study director
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human Papillomavirus 9-valent Vaccine, Recombinant in people with Cervical Lesion, run by Centre Oscar Lambret at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilie HEYMAN-DECOUPIGNY (0320295918, promotion@o-lambret.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of HPV-negative status (time frame: Within 2 years after the initial HPV control test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.