Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Anal 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 Penile 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 Vulvar Site
Conditions
Brief 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.
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
BIOLOGICALHPV vaccine
HPV vaccine, 3 timepoints : month 0, month 1-2, month 6
BIOLOGICALPlacebo vaccine
Placebo vaccine, 3 timepoints : month 0, month 1-2, month 6
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy : Centralised HPV genotyping of the initial HSIL and recurrent lesion will be performed. | 4.5 years | To assess the efficacy of Human papilloma virus (HPV) vaccination as secondary prevention in patients with gynecological or anal HSIL.The endpoint will be the time to HPV type-specific recurrence of HSIL at the initial site after completed HSIL treatment. |
Contacts
CONTACTElodie Lecerf, MSc
PRINCIPAL_INVESTIGATORJudith Michels, MD PhD
Gustave Roussy, Cancer Campus, Grand Paris
Outcome results
None listed