Human papillomavirus L1 proteins (types 6,11,16,18,31,33,45,52,58) - virus-like particles (recombinant, yeast-derived) for High-grade squamous intraepithelial lesion (HSIL) related to human papillomavirus (HPV)

Stratification factors

• Lesion location (cervical vs other)
• HIV status (HIV+, HIV-)
• Age (18≤ age ≤ 45 and age > 45 years)

Inclusion criteria

• {"criterion_text":"- Women, men, transgender,18 ≤age ≤55\n- ECOG performance status ≤ 1\n- Patients infected with HIV are eligible for the study provided they are receiving antiretroviral therapy with undetectable viral load\n- Biopsy-proven HPV related HSIL at any site (vulvar VIN, vaginal VaIN, cervical CIN, anal AIN, penile) at baseline\n- Women of childbearing potential must have a negative urine pregnancy test 24 hours prior to the administration of the first vaccine injection\n- Sexually active patients must agree to use acceptable and appropriate contraception while included in BIO-HPV study and until the last dose of vaccine\n- Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol\n- Patients must be affiliated to a social security system or beneficiary of the same\n- Life expectancy of greater than 5 years"}

Exclusion criteria

• {"criterion_text":"- History of HPV related cancer (i.e. anal, genital, head and neck)\n- Pregnant women or intent to become pregnant\n- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent\n- History of prior treatment of HSIL at the same site then currently treated\n- Warts so extensive that they preclude the clinician from determining the extent and location of HSIL\n- Prior HPV vaccination\n- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 21 days prior to the first dose of trial treatment\n- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study treatment\n- Prior malignancy active within the previous 3 years except from cancers with an expected PFS at 5 years of >95%\n- Hypersensitivity to the active substances or to any of the excipients (Listed in the SmPC)\n- Acute or severe febrile illness. Vaccination must be postponed until the individual has fully recovered"}

Primary endpoints

• {"endpoint_text":"- The endpoint will be the time to HPV type-specific recurrence of HSIL at the initial site after completed HSIL treatment. Centralised HPV genotyping of the initial HSIL and recurrent lesion will be performed.","definition_or_measurement_approach":"Measured as time to HPV type-specific recurrence of HSIL at the initial site after completed HSIL treatment; centralised HPV genotyping of the initial HSIL and recurrent lesion will be performed; assessed every 6 months for 24 months from the end of HSIL treatment."}

Secondary endpoints

• {"endpoint_text":"- Time to HPV clearance","definition_or_measurement_approach":"Time-to-event analysis for clearance of HPV infection (definition as per protocol)."}
• {"endpoint_text":"- Time to HSIL occurrence at different sites","definition_or_measurement_approach":"Time-to-event analysis for occurrence of HSIL at sites other than the initial treated site."}
• {"endpoint_text":"- Time to occurrence of invasive HPV-related cancer","definition_or_measurement_approach":"Time-to-event analysis for diagnosis of invasive HPV-related cancer."}
• {"endpoint_text":"- Safety based on reported adverse events","definition_or_measurement_approach":"Safety assessed by collection and reporting of adverse events."}
• {"endpoint_text":"- Decrease of 50% recurrence rate of HSIL within 2 years of follow-up once the HSIL treatment is completed.","definition_or_measurement_approach":"Comparison of HSIL recurrence rates within 2 years post-treatment; target is a 50% decrease versus control."}
• {"endpoint_text":"- Adverse events (AE) according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCICTCAE)","definition_or_measurement_approach":"AEs graded and reported according to NCI CTCAE v5.0."}
• {"endpoint_text":"- Viral and Immune signature for HSIL stratification","definition_or_measurement_approach":"Assessment of viral and immune biomarkers/signature for stratification of HSIL (as defined in protocol)."}
• {"endpoint_text":"- Assessment of the sexual health of the enrolled patients and current sexual partner(s) at different time points (i.e. baseline, end of 2-years follow-up, end of 5-years follow-up).","definition_or_measurement_approach":"Patient- and partner-reported sexual health questionnaires administered at baseline, 2-year and 5-year follow-up time points."}
• {"endpoint_text":"- Resource use and costs will be assessed from linkage to French National Health Data System (SNDS, Système National des Données de Santé)","definition_or_measurement_approach":"Health resource utilization and costs evaluated via linkage to the SNDS database for economic analyses (cost-utility and budget impact)."}

France

Earliest CTIS Part Ii Submission Date

15-12-2025

Latest Decision Or Authorization Date

28-01-2026

Processing Time Days

44

Number Of Sites

16

Number Of Participants

984

Primary sponsor

Full Name

Institut Gustave Roussy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France