HPV vaccine may stop precancerous lesions from returning

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.