HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA; HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN - ADSORBED ... (and other HPV L1 proteins for types 45, 52, 58, 11, 16, 18, 6) (as listed in product dictionary) for High-grade cervical intraepithelial lesions

Inclusion criteria

• {"criterion_text":"- Patient aged over 45"}
• {"criterion_text":"- Patient treated by conisation for a high-grade cervical lesion"}
• {"criterion_text":"- Positive HPV test at the recommended 6-month post-operative follow-up (a delay of 6 to 12 months will be accepted) leading to an indication for a follow-up colposcopy (+/- biopsy) in accordance with standard surveillance practices."}
• {"criterion_text":"- For cohort \"vaccinated patients\" : No contraindication to HPV vaccination with Gardasil 9"}
• {"criterion_text":"- For cohort \"vaccinated patients\" : Patient who has consented to HPV vaccination with Gardasil 9"}
• {"criterion_text":"- For cohort \"vaccinated patients\": Affiliated to a public health insurance program"}
• {"criterion_text":"- For cohort \"vaccinated patients\" : Signed, informed consent form"}
• {"criterion_text":"- For cohort \"non-vaccinated patients\" : Refusal of vaccination or contraindication to vaccination"}
• {"criterion_text":"- For cohort \"non vaccinated patients\" : Non-objection to the use of their personal data for research purposes"}

Exclusion criteria

• {"criterion_text":"- History of primary vaccination"}
• {"criterion_text":"- History of HPV-induced invasive cancer (cervical, vaginal, vulvar, anal, oropharyngeal)"}
• {"criterion_text":"- For cohort “vaccinated patients” : Patient refusing vaccination"}
• {"criterion_text":"- For cohort \" vaccinated patients\" : Patient with a contraindication to HPV vaccination with Gardasil 9"}
• {"criterion_text":"- For cohort \"vaccinated patients\" : Patient deprived of liberty or under guardianship"}
• {"criterion_text":"- For cohort “non-vaccinated patients”: Objection to the use of their personal data for research purposes"}

Primary endpoints

• {"endpoint_text":"- HPV-negative status within 24 months of the initial HPV control test, HPV-negative statu is defined as a negative. If the patient cannot be assessed at 2 years due to the occurrence of cancer beforehand, the observation will be considered a failure (equivalent to the absence of negativation).","definition_or_measurement_approach":"HPV-negative status defined by a negative HPV test within 24 months of the initial HPV control test; if patient cannot be assessed at 2 years because of prior occurrence of cancer, considered a failure (absence of negativation)."}

Secondary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"HPV status assessed by cervical smear every 12 months until negativation (within up to 5 years of follow-up). If negative, a control smear is performed three years later (within the 5-year follow-up window)."}
• {"endpoint_text":"- Adverse Events (AEs) will be assessed according to the NCI-CTCAE V5.0 over the total duration of the vaccination schedule plus 30 days. AEs will be collected after each injection, at the next injection for the first 2 injections, and by a telephone call (+/- consultation if necessary) at 30 days after the 3rd injection. AEs clearly related to the underlying disease or its progression will be excluded. Grade ≥3 AEs will be considered as severe AEs. All serious adverse events will be reported im","definition_or_measurement_approach":"AEs graded per NCI-CTCAE v5.0 over vaccination period plus 30 days; collection after each injection, at next injection for first two injections, and by telephone (± consultation) 30 days after 3rd injection; Grade ≥3 considered severe; serious adverse events reported."}
• {"endpoint_text":"- To estimate the incidence of recurrence of high-grade intraepithelial lesion, we will calculate the time between the date of the initial HPV control test and the first of the event (recurrence of high-grade intraepithelial lesion of the uterine cervix, occurrence of HPV-related cancer whatever the location: uterine cervix, vagina, vulva).","definition_or_measurement_approach":"Incidence estimated by time from initial HPV control test to first event (recurrence of high-grade intraepithelial lesion or occurrence of HPV-related cancer at cervix, vagina, vulva)."}
• {"endpoint_text":"- To estimate the incidence of invasive gynaecological cancer (cervix, vagina or vulva), we will calculate the time between the date of the initial HPV control test and the occurrence of HPV-related invasive cancer at any location (cervix, vagina, vulva).","definition_or_measurement_approach":"Incidence estimated by time from initial HPV control test to occurrence of HPV-related invasive gynecological cancer (cervix, vagina, vulva)."}
• {"endpoint_text":"- Compliance with the vaccination schedule will be assessed by o\tthe number of injections received o\tthe timing of injections (time to start vaccination, time between each injections, time between the 1st and 3rd injections).","definition_or_measurement_approach":"Compliance assessed by number of injections received and timing metrics: time to start vaccination, intervals between injections, and time between 1st and 3rd injections."}

France

Earliest CTIS Part Ii Submission Date

23-09-2024

Latest Decision Or Authorization Date

08-01-2026

Processing Time Days

472

Number Of Sites

3

Number Of Participants

85

Primary sponsor

Full Name

Centre Oscar Lambret

Organisation Type

Pharmaceutical company

Country Of Registered Address

France