Trial to Evaluate Nonavalent HPV Vaccine as a Secondary Prevention in Patients Treated for Human … (NCT07431502) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Trial to Evaluate Nonavalent HPV Vaccine as a Secondary Prevention in Patients Treated for Human Papilloma Virus Related High-grade Squamous Intraepithelial Lesions
984 participantsStarted 2026-05
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexALL
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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 parti…
What they're measuring
1
Efficacy : Centralised HPV genotyping of the initial HSIL and recurrent lesion will be performed.