Trial to Evaluate Nonavalent HPV Vaccine as a Secondary Prevention in Patients Treated for Human Papilloma Virus Related High-grade Squamous Intraepithelial Lesions

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vulvar Site, Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vaginal Site, Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Penile Site, Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Cervical Site, Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Anal Site

In brief

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.

Key facts

Study ID

NCT07431502

Run by

Gustave Roussy, Cancer Campus, Grand Paris

People needed

984

Starts

2026-05-01

Expected to finish

2030-11-01

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.