Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 1:10 AM
Study NCT ID:
NCT07431502
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial to Evaluate Nonavalent HPV Vaccine as a Secondary Prevention in Patients Treated for Human Papilloma Virus Related High-grade Squamous Intraepithelial Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081483', 'term': 'Squamous Intraepithelial Lesions'}], 'ancestors': [{'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053918', 'term': 'Papillomavirus Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 984}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy : Centralised HPV genotyping of the initial HSIL and recurrent lesion will be performed.', 'timeFrame': '4.5 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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', 'Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Anal Site']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women, men, transgender,18 ≤age ≤55\n* ECOG performance status ≤ 1\n* Patients infected with HIV are eligible for the study provided they are receiving antiretroviral therapy with undetectable viral load.\n* Biopsy-proven HPV related HSIL at any site (vulvar VIN, vaginal VaIN, cervical CIN, anal AIN, penile PeIN) at baseline.\n* Women of childbearing potential must have a negative urine pregnancy test 24 hours prior to the administration of the first vaccine injection.\n* Sexually active patients must agree to use acceptable and appropriate contraception while included in BIO-HPV study and until the last dose of vaccine.\n* 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.\n* Patients must be affiliated to a social security system or beneficiary of the same\n* Life expectancy of greater than 5 years\n\nExclusion Criteria:\n\n* History of HPV related cancer (i.e. anal, genital, head and neck, cutaneous, penile)\n* History of prior treatment of HSIL\n* Warts so extensive that they preclude the clinician from determining the extent and location of HSIL Prior HPV vaccination\n* 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.\n* 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.\n* Prior malignancy active within the previous 3 years except from cancers with an expected PFS at 5 years of \\>95%.\n* Hypersensitivity to the active substances or to any of the excipients (Listed in the SmPC).\n* Acute or severe febrile illness. Vaccination must be postponed until the individual has fully recovered.\n* Pregnant women or intent to become pregnant\n* Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.'}, 'identificationModule': {'nctId': 'NCT07431502', 'acronym': 'BioHPV', 'briefTitle': 'Trial to Evaluate Nonavalent HPV Vaccine as a Secondary Prevention in Patients Treated for Human Papilloma Virus Related High-grade Squamous Intraepithelial Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Gustave Roussy, Cancer Campus, Grand Paris'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2024-520140-42-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo vaccination, 3 timepoints', 'interventionNames': ['Biological: Placebo vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'HPV Vaccine', 'description': 'HPV vaccination, 3 timepoints', 'interventionNames': ['Biological: HPV vaccine']}], 'interventions': [{'name': 'HPV vaccine', 'type': 'BIOLOGICAL', 'description': 'HPV vaccine, 3 timepoints : month 0, month 1-2, month 6', 'armGroupLabels': ['HPV Vaccine']}, {'name': 'Placebo vaccine', 'type': 'BIOLOGICAL', 'description': 'Placebo vaccine, 3 timepoints : month 0, month 1-2, month 6', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Elodie Lecerf, MSc', 'role': 'CONTACT', 'email': 'elodie.lecerf@gustaveroussy.fr', 'phone': '+33 42 11 42 11'}], 'overallOfficials': [{'name': 'Judith Michels, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gustave Roussy, Cancer Campus, Grand Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gustave Roussy, Cancer Campus, Grand Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}