Randomized, placebo-controlled phase 3 trial to evaluate nonavalent HPV vaccine as a secondary prevention in patients treated for human papilloma virus related high-grade squamous intraepithelial lesions.

BioHPV is a randomized, double-blinded, placebo-controlled, multi-center, phase III trial evaluating nonavalent HPV (9vHPV) vaccine in 984 patients aged ≤55 undergoing HSIL treatment at any site (gynecological (i.e. vulvar, vaginal, cervical), anal, penile).

Inclusion Criteria:

• Women, men, transgender,18 ≤age ≤55
• ECOG performance status ≤ 1
• Patients infected with HIV are eligible for the study provided they are receiving antiretroviral therapy with undetectable viral load.
• Biopsy-proven HPV related HSIL at any site (vulvar VIN, vaginal VaIN, cervical CIN, anal AIN, penile PeIN) at baseline.
• Women of childbearing potential must have a negative urine pregnancy test 24 hours prior to the administration of the first vaccine injection.
• Sexually active patients must agree to use acceptable and appropriate contraception while included in BIO-HPV study and until the last dose of vaccine.
• 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.
• Patients must be affiliated to a social security system or beneficiary of the same
• Life expectancy of greater than 5 years

Exclusion Criteria:

• History of HPV related cancer (i.e. anal, genital, head and neck, cutaneous, penile)
• History of prior treatment of HSIL
• Warts so extensive that they preclude the clinician from determining the extent and location of HSIL Prior HPV vaccination
• 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.
• 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.
• Prior malignancy active within the previous 3 years except from cancers with an expected PFS at 5 years of >95%.
• Hypersensitivity to the active substances or to any of the excipients (Listed in the SmPC).
• Acute or severe febrile illness. Vaccination must be postponed until the individual has fully recovered.
• Pregnant women or intent to become pregnant
• Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.