[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"human-papilloma-virus-infection-type-16\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:human-papilloma-virus-infection-type-16":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100627921","phase-2-pvx4-for-the-treatment-of-human-papilloma-virus-hpv16-cervical-dysplasia-100627921",false,"NCT07454915","PVX4 for the Treatment of Human Papilloma Virus (HPV)16+ Cervical Dysplasia","Inclusion Criteria:\n\n1. Female subjects 18-60 years old with biopsy-confirmed high grade cervical intraepithelial neoplasia (CIN2\u002F3) confirmed by central review.\n2. Patients whose cytobrush samples are HPV16+ by Roche Cobas genotyping test. Co-infections with HPV types other than HPV16 are permissible for study entry\n3. HIV negative\n4. Patients who are able and willing to comply with all study procedures, and with anticipated availability for the planned follow-up period of one year\n5. Patients who are of childbearing potential agree to remain sexually abstinent, use methods of contraception (e.g. oral contraception, barrier methods, spermicide, intrauterine device (IUD)), or have a partner who is sterile (i.e., vasectomy) through 6 months.\n6. Patients must have adequate organ function at the time of enrollment as defined by the following parameters: white blood cell count \\>3,000\u002FmcL; lymphocyte number \\>500\u002FmcL; absolute neutrophil count \\>1,000\u002FmcL; platelets \\>90,000\u002FmcL; hemoglobin \\>9 g\u002FdL; total bilirubin \\\u003C3 X the institutional limit of normal; aspartate aminotransferase (AST \\[SGOT\\]) \u002F alanine aminotransferase (ALT \\[SGPT\\]) \\\u003C3 X the institutional limit of normal; creatinine \\\u003C2.5X the institutional limit of normal.\n\nExclusion Criteria:\n\n1. Patients who are attempting pregnancy within 6 months, pregnant, or breastfeeding.\n2. Patients with immunodeficiency, or treatment with immunosuppressive medications\n3. Administration of any blood product within 3 months of enrollment.\n4. Administration of any licensed vaccine within 2 weeks of enrollment (4 weeks for a live vaccine)\n5. Participation in a study with an investigational compound or device within 30 days of signing informed consent.\n6. History of seizures (unless seizure free for 5 years)\n7. Previous cancer history within the past 5 years, except localized skin cancer.\n8. Patients who have had chemotherapy, radiation, biological cancer therapy, or other investigational agents within 28 days prior to the first dose of study drug.\n9. Patients who have had surgery within 28 days, excluding minor procedures (dental work, skin biopsy, etc).\n10. 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 with study requirements.\n11. Patients who have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis).\n12. Previous cervical conization or LEEP procedure or previous total hysterectomy due to cervical lesions at enrollment\n13. High-grade intraepithelial lesions (CIN2\u002F3) encompassing more than 180-degree (more than 2 quarters) of cervix\n14. Positive HBV PCR if Hepatitis B surface antigen positive\n15. Positive HCV PCR if anti-HCV positive\n16. Border of high-grade intraepithelial lesions (CIN2\u002F3) could not be completely observed by colposcope and positive for high grade disease by endocervical curettage.\n17. Cervical biopsy and\u002For ECC of adenocarcinoma in situ (AIS)\n18. Pre-biopsy Pap of Atypical Glandular Cells (AGC)\u002FAGC favor neoplasm, squamous cell carcinoma (SCC), or cervical biopsy of CIN2\u002F3 with postmenopausal bleeding\n19. Participant has:\n\n    1. Less than 2 acceptable potential injection sites for IM injection and electroporation considering the left and right medial deltoid, and anterolateral quadriceps muscles. A site for injection and electroporation is not acceptable if there is inadequate muscle mass to support at least a 19 mm\u002F0.75 inch injection depth or a skinfold thickness measurement of ≥50 mm as assessed using the provided caliper. Eligible injection sites must also be free from tattoos, hypertrophic skin patches, keloids or other skin conditions which could interfere with the administration procedure or subsequent assessment of local reactogenicity.\n    2. Note: To ensure adequate muscle mass for administrations, for participants with a weight ≤65 kg, potentially eligible administration sites are confined to the outer aspect of the upper thigh (left or right vastus lateralis muscle) (i.e., the left and right medial deltoid are not eligible administration sites).\n20. Contraindication to intramsucular injections and blood draws.\n21. A metal implant or implantable device within the area of the electroporation injection site at \\> 2 of the eligible injection sites.\n22. A nonremovable electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.\n23. Participant is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.\n24. Vulnerable participants (e.g., incarcerated individuals, individuals under a legal protection measure).","FEMALE","18 Years","60 Years",{"count":19,"type":20},138,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this Phase 2 study is to compare the effects of administering the PVX4 combination device biologic product (pBI-4 DNA vaccine via electroporation-mediated intramuscular delivery with the TriGrid™ Delivery System) in patients with biopsy-confirmed, human papilloma virus (HPV) 16-associated high grade cervical intraepithelial neoplasia (CIN2\u002F3) as compared to the administration of placebo.",[26,27],"Cervical Intraepithelial Neoplasia Grade 2\u002F3","Human Papilloma Virus Infection Type 16",[29,30,31,32,33,34],"Human papilloma virus","HPV16","HSIL","CIN 2\u002F3","DNA vaccine","Cervical intraepithelial neoplasia","RECRUITING","2026-05-03",{"date":38,"type":39},"2026-05-06","ACTUAL",{"date":41,"type":39},"2026-04-01",{"date":43,"type":20},"2028-06",{"name":45,"class":46},"PapiVax Biotech, Inc.","OTHER",10,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100624279","phase-2-developing-a-first-void-urine-based-infection-model-to-study-hpv-specific-antibody-virion-interaction-before-and-after-hpv-vaccination-100624279","NCT07407569","Developing a First-void Urine-based Infection Model to Study HPV-specific Antibody-virion Interaction Before and After HPV Vaccination","Developing a First-void Urine-based Infection Model to Study HPV-specific Antibody-virion Interaction Before and After Vaccination With the Gardasil-9 HPV Vaccine - a Non-randomized Open-label Study.","URVIVE","Candidates are eligible for inclusion in the study if they:\n\n* Are females between 18 and 45 years old (including both limits) at the time of signing the informed consent form.\n* Have tested positive for HPV16 DNA (single or co-infection) but have no presence of apparent anogenital lesions and are thus not referred for treatment or intervention at the time of inclusion or within the last twelve months before inclusion.\n* Did not receive prior vaccination with a prophylactic HPV vaccine.\n* Are able to understand the information brochure and what the study is about.\n* Are willing to give informed consent to the study team to access their medical records, including details on their HPV vaccination schedule and cervical cancer screening results (smears, HPV tests, colposcopy, biopsy).\n\nCandidates must be excluded from the study if they:\n\n* Are previously (completely or partially) vaccinated against HPV or have planned administration of another HPV vaccine during the study.\n* Are pregnant at the time of signing informed consent or are planning to become pregnant within the full duration of the study. Participants must use an effective method of contraception throughout the entire study. Acceptable methods include combined hormonal contraception (oral, vaginal ring, transdermal patch), progestogen-only contraception (oral, injectable, implantable), intrauterine device (IUD)\u002Fintrauterine system (IUS), condom, vasectomized male partner, or (periodic) abstinence. Lactating women may be included.\n* Have had full hysterectomy.\n* Have had any anogenital lesion treated in the last twelve months before participating in the study.\n* Have invasive cancer (except basocellular carcinoma) or other immunocompromising conditions as described as high-risk in the latest scientific guidelines from Sciensano.\n* Use immunosuppressive therapy for inflammatory bowel disease, rheumatological disorders, neuromyelitis optica, sarcoidosis, adenocarcinoma in situ, or use of local anogenital corticosteroids.\n* Have used any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planning to use during the study period.\n* Have received immunoglobulin or blood-derived products in the three months prior to the first study vaccination (Month 0), or are expected to require immunoglobulin or blood-derived products from Month 1 until Month 7 of the study.\n* Receive any vaccine not foreseen in the study protocol administered in the period beginning 30 days preceding each dose of the study vaccine and ending one month (minimum 30 days) after each dose of the study vaccine.\n* Have known allergy or history of any reaction or hypersensitivity likely to be exacerbated by any component of the Gardasil 9 vaccine or known history of severe allergic reaction to other vaccines (e.g. anaphylaxis).\n* Are concurrently enrolled in another clinical study of investigational agents.\n* Have acute disease or contraindications for vaccination at the time of enrolment. Acute disease is defined as the presence of moderate or severe illness with or without fever. Enrolment will be deferred until the condition is resolved. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral\u002Faxillary temperature \\>37.5 °C.\n* Have a history or current evidence of any condition or abnormality that might confound the results of the study or is not in the best interest of the individual to participate, in the opinion of the investigator.\n* Are, as determined by the investigator, unlikely to adhere to the study procedures, keep appointments, or are planning to relocate from the area prior to completion of the study.","45 Years",{"count":58,"type":20},50,[23],"The current study is an open-label, non-randomized, longitudinal exploratory trial using the licensed Gardasil 9 (9vHPV) vaccine in an off-label context to investigate biological and immunological outcomes in human papillomavirus type 16 (HPV16) positive women. Two doses of the licensed Gardasil 9 vaccine will be administered to approximately 50 women between 18 and 45 years old, who test positive for HPV16 DNA at baseline using a type-specific quantitative PCR assay, but have no presence of apparent anogenital lesions and are thus not referred for treatment or intervention at the time of inclusion.\n\nThe primary objective of this study is to demonstrate that vaccination with a two-dose regimen of the 9vHPV vaccine reduces the viral infectivity of particles in the female genital tract of HPV16-positive women, by using first-void urine samples. The secondary objectives are to follow up HPV type-specific antibody responses in these first-void urine samples after natural infection and vaccination after one or two doses of the 9vHPV vaccine and to compare these with the responses in serum, and to monitor HPV infections in first-void urine over time.\n\nCandidates will be selected for participation based on the result of their HPV DNA test performed on a sample collected during routine screening or symptomatic (opportunistic) testing in one of the following centers:\n\n* The University Hospital of Antwerp (UZA).\n* The University Hospital of Leuven (UZ Leuven).\n* Ghent University Hospital (UZ Gent).\n\nWomen are followed for up to 24 months, in which first-void urine and serum samples will be collected at different timepoints.\n\nThe following laboratory procedures will be applied to reach study objectives\n\n* Assessment of HPV DNA positivity: HPV genotyping in first-void urine samples.\n* Assessment of HPV infectivity: Detection of HPV16 E1\\^E4 spliced mRNA in HaCaT keratinocytes after infection with virions from first-void urine samples.\n* Assessment of HPV immunogenicity: Detection of HPV-specific antibodies in first-void urine and serum samples.",[27],[63,64,65,66,67],"HPV-specific antibodies","Gardasil 9","Vaccination","Self-sampling","First-void urine","2026-03-25",{"date":70,"type":39},"2026-03-27",{"date":68,"type":39},{"date":73,"type":20},"2029-01-01",{"name":75,"class":46},"Universiteit Antwerpen",3]