[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"human-papillomavirus-16-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:human-papillomavirus-16-infection":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100658984","epidemiology-of-anal-human-papillomavirus-carriage-in-female-solid-organ-transplant-recipients-with-more-than-10-years-of-immunosuppression-100658984",false,"NCT07858201","Epidemiology of Anal Human Papillomavirus Carriage in Female Solid Organ Transplant Recipients With More Than 10 Years of Immunosuppression","Epidemiology of Anal Human Papillomavirus Carriage in Female Solid Organ Transplant Recipients With More Than 10 Years of Immunosuppression (EPAHTOS)","EPAHTOS","Inclusion Criteria:\n\n* Female aged 18 to 75 years.\n* Recipient of a kidney, liver and\u002For heart transplant for more than 10 years, or cumulative exposure to immunosuppressive therapy for more than 10 years.\n* Affiliated to a health insurance system.\n* Able to understand study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* History of anal cancer.\n* Current pregnancy.\n* Legal incapacity or inability to provide informed consent.\n* Participation deemed inappropriate by the investigator.","FEMALE","18 Years","75 Years",{"count":21,"type":22},190,"ESTIMATED","INTERVENTIONAL",[25],"NA","Anal canal cancer is primarily associated with persistent infection by high-risk human papillomavirus (HR-HPV), particularly HPV-16. Women who have undergone solid organ transplantation are at increased risk of anal cancer because of the chronic immunosuppression required to maintain graft function. However, epidemiological data regarding the prevalence of anal HPV-16 and other HR-HPV types in this population remain limited and sometimes conflicting.\n\nEPAHTOS is a single-center, cross-sectional, observational study (French Category 2 Interventional Research Involving Human Participants \\[RIPH 2\\]) conducted at Montpellier University Hospital. The study aims to evaluate the prevalence of anal HPV-16 carriage among women aged 18 to 75 years who underwent kidney, liver, and\u002For heart transplantation more than 10 years previously, or who have received cumulative immunosuppressive therapy for more than 10 years. A total of 190 participants will be enrolled.\n\nAt the inclusion visit, participants will receive information about the study, provide written informed consent, complete a self-administered questionnaire including questions on HPV infection risk factors, and perform a self-collected anal sample for the detection of high-risk HPV by polymerase chain reaction (PCR). This test allows identification of HPV-16 as well as other HR-HPV genotypes.\n\nThe primary objective is to estimate the prevalence of anal HPV-16 carriage. Secondary objectives include assessing the distribution of other anal HR-HPV genotypes, describing cytological abnormalities associated with HR-HPV infections, estimating the prevalence of anal histological lesions detected by high-resolution anoscopy among eligible participants, identifying factors associated with HR-HPV carriage, evaluating the feasibility of anal self-sampling, and describing the distribution of cervical HR-HPV infections.\n\nIn accordance with French recommendations, participants testing positive for HPV-16 will receive standard clinical management including reflex anal cytology and, in the event of a cytological abnormality, referral for proctology consultation with high-resolution anoscopy. Within the framework of the study, participants carrying an HR-HPV genotype other than HPV-16 and presenting abnormal cytology will also be offered standard proctological evaluation to ensure that clinically significant anal lesions are not overlooked.\n\nThe results of this study will provide updated information on the epidemiology of HPV infections among female solid organ transplant recipients and may contribute to the development of future anal cancer screening strategies in this high-risk population.",[28,29,30],"Human Papillomavirus Infection","Anal HPV Infection","Human Papillomavirus 16 Infection",[29,32,33],"Anal Intraepithelial Neoplasia","Anal Cancer","NOT_YET_RECRUITING","2026-09-29",{"date":37,"type":38},"2026-10-05","ACTUAL",{"date":40,"type":22},"2026-10",{"date":42,"type":22},"2028-10-01",{"name":44,"class":45},"University Hospital, Montpellier","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":5},"100655315","phase-1-phase-iii-trial-of-electroporation-delivered-pbi-4-vaccine-trigrid-pvx4-for-treatment-of-women-with-hpv16-positive-cin1-or-persistent-infection-100655315","NCT07809997","Phase I\u002FII Trial of Electroporation-Delivered pBI-4 Vaccine (TriGrid™ PVX4) for Treatment of Women With HPV16-Positive CIN1 or Persistent Infection","A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of pBI-4 Plasmid Administered Via Intramuscular TriGrid™ Electroporation Delivery System for Treatment of Women With HPV16-Positive Grade 1 Cervical Intraepithelial Neoplasia or Persistent HPV16 Infection","Inclusion Criteria:\n\n* Patients with CIN1 on biopsy and whose cytologic sample is HPV16+ by Roche Cobas test in the past 30 days, OR patients with CIN\\\u003C1 on biopsy whose cytologic sample is HPV16+ by Roche Cobas test in the past 30 days and a history of a second HPV16+ test at least 6 months prior\n\n  * (Co-infections with HPV types other than HPV16 are permissible for study entry)\n  * Age ≥ 19 years\n  * Baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of study treatment administration\n  * Adequate organ function at the time of enrollment as defined by:\n\nWhite blood cell count \\> 3,000\u002FmcL Absolute lymphocyte number \\> 500\u002FmcL Absolute neutrophil count \\> 1,000\u002FmcL Platelets \\> 90,000\u002FmcL Hemoglobin \\> 9 g\u002FdL Total bilirubin \\\u003C 3 x institutional limit of normal AST(SGOT)\u002FALT(SGPT) \\\u003C 3 x institutional limit of normal Creatinine \\\u003C 2.5 x institutional limit of normal Women of child-bearing potential must agree to use effective contraception (hormonal and\u002For barrier) prior to study entry and for the duration of the study\n\n* Ability to understand and willingness to sign a written informed consent document\n* Subject is able to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n* Patients with AIS (adenocarcinoma in situ) or cancer determined by cervical cytology at study entry\n\n  * Histologic evidence of CIN2 or above\n  * Patients with a diagnosis of immunosuppression or prolonged, active use of immunosuppressive medications such as steroids\n  * Prior treatment with any HPV therapeutic agent (e.g., Imiquimod, Veregen, Podophylotoxin)\n  * Patients who are receiving any other investigational agents or blood products within 30 days prior to the first dose\n  * Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance\n  * Patients with a history of autoimmune disease such as multiple sclerosis (exclusive of a history of thyroiditis, psoriasis, Sjogren's, or inflammatory bowel disease)\n  * Patients with a history of allergic reactions attributed to compounds used in agent preparation\n  * Patients who are pregnant or breast feeding\n  * Patients with active or chronic infection of HIV, HCV, or HBV\n  * Patients who have had a prior LEEP or cervical conization procedure\n  * History of prior malignancy (permitted only if the patient has been disease-free for ≥ 5 years, or has completely resected basal cell or squamous cell carcinoma of the skin)\n  * Less than 1 acceptable potential injection site for intramuscular injection and electroporation (considering the left\u002Fright medial deltoid, and anterolateral quadriceps muscles)\n  * A site is unacceptable if there is inadequate muscle mass to support at least a 19 mm (0.75 inch) injection depth or a skinfold thickness of ≥ 50 mm\n  * (Note: For participants weighing ≤ 65 kg, acceptable sites are confined to the outer aspect of the upper thigh, and the deltoids are not eligible)\n  * Contraindication to intramuscular injections and blood draws\n  * A metal implant or implantable device within the area of the electroporation injection site at \\> 2 of the eligible injection sites .A nonremovable electronic stimulation device (such as cardiac demand pacemakers, automatic implantable cardiac defibrillators, nerve stimulators, or deep brain stimulators).","19 Years","65 Years",{"count":56,"type":22},94,[58,59],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety, efficacy, and tolerability of pBI-4, an investigational therapeutic DNA vaccine, in treating adult women with Human Papillomavirus type 16 (HPV16)-positive Grade 1 cervical intraepithelial neoplasia (CIN1) or persistent HPV16 infection.\n\nThis is a randomized, double-blind, placebo-controlled, multicenter Phase II trial in Taiwan, aiming to enroll a total of 94 female participants. Participants will be randomly assigned (1:1 ratio) to receive either a single 1.0 mg dose of the pBI-4 vaccine or a placebo. The study drug or placebo will be administered intramuscularly in the thigh muscle using the TriGrid™ Delivery System version 2.0 (TDS-IM v2.0), a specialized device that applies short, mild electrical pulses (electroporation) to help cells take up the vaccine and stimulate a stronger immune response.\n\nThe primary goal of the study is to compare the rate of HPV16 viral clearance between the vaccine and placebo groups at Month 6. The study also features an adaptive design: an interim analysis will be conducted after approximately 50% of participants complete their 6-month assessment. If the initial single-dose regimen shows suboptimal efficacy at the interim stage, the trial may adaptively switch to a two-dose (prime-boost) regimen administered one month apart for the remaining participants. All participants will be closely monitored for safety, side effects, and immune responses for a total duration of 12 months.",[62,30],"Cervical Intraepithelial Neoplasia Grade 1","2026-09-10",{"date":65,"type":38},"2026-09-14",{"date":67,"type":22},"2026-09",{"date":69,"type":22},"2030-03",{"name":71,"class":45},"Chang Gung Memorial Hospital"]