[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"patients-with-primary-hpv-high-grade-squamous-intra-epithelial-lesions-hsil-at-penile-site\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:patients-with-primary-hpv-high-grade-squamous-intra-epithelial-lesions-hsil-at-penile-site":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"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":20,"type":21},984,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31],"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":35,"type":36},"2026-02-27","ACTUAL",{"date":38,"type":21},"2026-05",{"date":40,"type":21},"2030-11",{"name":42,"class":43},"Gustave Roussy, Cancer Campus, Grand Paris","OTHER",""]