Trial to Evaluate Nonavalent HPV Vaccine as a Secondary Prevention in Patients Treated for Human Papilloma Virus Related High-grade Squamous Intraepithelial Lesions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HPV vaccine, Placebo vaccine.
- Who it may be relevant to
- Registry conditions: 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. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
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).
Interventions
- Biological HPV vaccine
HPV vaccine, 3 timepoints : month 0, month 1-2, month 6 - Biological Placebo vaccine
Placebo vaccine, 3 timepoints : month 0, month 1-2, month 6
Primary outcome measures
- Efficacy : Centralised HPV genotyping of the initial HSIL and recurrent lesion will be performed. [Time frame: 4.5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07431502 · 2024-520140-42-00