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Multicenter, randomized, double-blinded, 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)
EU CTIS ID: 2024-520140-42-00
What this study is testing
To assess the efficacy of Human papilloma virus (HPV) vaccination as secondary prevention in patients with gynecological or anal HSIL.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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) 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
You likely can't join if
- History of HPV related cancer (i.e. anal, genital, head and neck)
- 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
- History of prior treatment of HSIL at the same site then currently treated
- Warts so extensive that they preclude the clinician from determining the extent and location of HSIL
- Prior HPV vaccination
See the full eligibility 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) 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
- History of HPV related cancer (i.e. anal, genital, head and neck)
- 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
- History of prior treatment of HSIL at the same site then currently treated
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.