[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626120":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":26,"responsibleParty":41,"collaborators":26,"id":43,"slug":26,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":26,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":26,"overallStatus":66,"whyStopped":26,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":26},{"fullName":5,"class":6},"Gustave Roussy, Cancer Campus, Grand Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Placebo vaccination, 3 timepoints",[13],"Biological: Placebo vaccine",{"label":15,"type":16,"description":17,"interventionNames":18},"HPV Vaccine","EXPERIMENTAL","HPV vaccination, 3 timepoints",[19],"Biological: HPV vaccine",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","HPV vaccine","HPV vaccine, 3 timepoints : month 0, month 1-2, month 6",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo vaccine","Placebo vaccine, 3 timepoints : month 0, month 1-2, month 6",[9],[32],{"name":33,"affiliation":5,"role":34},"Judith Michels, MD PhD","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Elodie Lecerf, MSc","CONTACT","+33 42 11 42 11","elodie.lecerf@gustaveroussy.fr",{"type":42,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100626120",false,"NCT07431502","Trial to Evaluate Nonavalent HPV Vaccine as a Secondary Prevention in Patients Treated for Human Papilloma Virus Related High-grade Squamous Intraepithelial Lesions","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","BioHPV","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.","ALL","18 Years","55 Years",{"count":54,"type":55},984,"ESTIMATED","INTERVENTIONAL",[58],"PHASE3","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.",[61,62,63,64,65],"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","NOT_YET_RECRUITING","2026-02-24",{"date":69,"type":70},"2026-02-27","ACTUAL",{"date":72,"type":55},"2026-05",{"date":74,"type":55},"2030-11",{"name":5,"class":6}]