Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Human Papillomavirus 9-valent Vaccine, Recombinant

    Biological/Vaccine

    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.

Treatment groups

85 Participants
are divided into 2 treatment groups
Group A: Vaccinated patientsExperimental treatment 1 intervention
Group B: Non-vaccinated patientsNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Within 2 years after the initial HPV control test

Secondary outcomes

1

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)

Time frame
every 12 months for up to 5 years
2

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.

Time frame
Throughout the vaccination schedule plus 30 days
3

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.

Time frame
From the initial HPV control test up to the first recurrence event up to 5 years
4

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)

Time frame
From the initial HPV control test to the occurrence of invasive cancer up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Oscar Lambret

Lead sponsor

Canceropôle Nord Ouest

Collaborator

Source ClinicalTrials.gov
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