[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536280":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":54,"collaborators":57,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":20,"enrollmentInfo":75,"targetDuration":20,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":20,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Central Adelaide Local Health Network Incorporated","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Vaccination group","EXPERIMENTAL","All participants will receive the assigned intervention, a 2-dose course of Zoster recombinant adjuvanted vaccine. Study participants will include kidney transplant recipients receiving specific immunosuppressive medications, and non-immunosuppressed household cohabitants, with comparisons made in magnitude of vaccine response.",[13],"Biological: Recombinant zoster vaccine adjuvanted (SHINGRIX)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Recombinant zoster vaccine adjuvanted (SHINGRIX)","2 doses of 0.5mL recombinant zoster vaccine adjuvanted intramuscular injection at week 0 and week 8.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Patrick T Coates, FRACP","Central and Northern Adelaide Renal and Transplantation Services","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Patrick T Coates, MBBS, FRACP, PhD","CONTACT","70740000","Toby.Coates@sa.gov.au",{"name":33,"role":29,"phone":30,"phoneExt":20,"email":34},"Griffith B Perkins, PhD","Griffith.Perkins@adelaide.edu.au",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Royal Adelaide Hospital","RECRUITING","Adelaide","South Australia","5000","Australia","AU",{"type":45,"coordinates":46},"Point",[47,48],138.59863,-34.92866,{"lat":48,"lon":47},[51],{"name":52,"role":29,"phone":53,"phoneExt":20,"email":31},"Patrick T Coates, PhD FRACP","+6170740000",{"type":25,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Matthew Tunbridge","Principal Investigator",[58,61,63],{"name":59,"class":60},"National Health and Medical Research Council, Australia","OTHER",{"name":62,"class":60},"University of Adelaide",{"name":64,"class":60},"Royal Prince Alfred Hospital, Sydney, Australia","100536280","safety-and-immunogenicity-of-recombinant-zoster-vaccine-for-transplant-recipients-100536280",false,"NCT06262776","Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients","Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients (SIR ZOSTER)","SIR ZOSTER","1. Population - Group 1. Healthy co-habitants (n = 30)\n\n   Inclusion criteria:\n   * Household co-habitant of transplant recipient in trial\n   * Aged \\>50 years\n   * Previous documented infection with VZV (known infection history or positive VZV IgG result)\n\n   Exclusion criteria:\n   * Aged \\\u003C50 years\n   * Unable or unwilling to provide informed consent to participate in the trial\n   * Known allergy to or intolerance of the contents of the RZV vaccine\n   * No previous infection with VZV (chickenpox)\n   * History of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy\n2. Population - Groups 2-4. Transplant recipients (n = 90)\n\n   Inclusion criteria:\n   * Organ transplant recipients\n\n     \\-- Specific immunosuppression regimen\n     * Tacrolimus, mycophenolate, prednisolone (n = 30, Group 2)\n     * Tacrolimus, mTORi, prednisolone (n = 30, Group 3)\n     * mTORi, mycophenolate, prednisolone (n = 30, Group 4)\n   * Aged \\>18 years\n   * estimated GFR \\> 15 mL\u002Fmin\u002F1.73m2\n   * Previous documented infection with VZV (known infection history or positive VZV IgG result)\n\n   Exclusion criteria:\n   * Aged \\\u003C18 years\n   * Unable or unwilling to provide informed consent to participate in the trial\n   * No previous infection with VZV (chickenpox)\n   * Known allergy to or intolerance of the contents of the RZV vaccine\n   * Current pregnancy\n3. Population - Group 5. Other (n = 10)\n\n   Inclusion criteria:\n   * Immunosuppressed patient receiving single-agent rapamycin immunosuppression\n   * Aged \\>18 years\n   * Previous documented infection with VZV (known infection history or positive VZV IgG result)\n\n   Exclusion criteria:\n   * Aged \\\u003C18 years\n   * Unable or unwilling to provide informed consent to participate in the trial\n   * Known allergy to or intolerance of the contents of the RZV vaccine\n   * No previous infection with VZV (chickenpox)\n   * Known allergy to or intolerance of the contents of the RZV vaccine\n   * Current pregnancy\n   * History of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy\n4. Population - Group 6. Dialysis group (n = 30)\n\nInclusion criteria:\n\n* Kidney failure receiving haemodialysis as kidney replacement therapy\n* Aged \\>18 years\n* Previous documented infection with VZV (known infection history or positive VZV IgG result)\n\nExclusion criteria:\n\n* Aged \\\u003C18 years\n* Unable or unwilling to provide informed consent to participate in the trial\n* Known allergy to or intolerance of the contents of the RZV vaccine\n* No previous infection with VZV (chickenpox)\n* Known allergy to or intolerance of the contents of the RZV vaccine\n* Current pregnancy\n* History of primary immunodeficiency or active immunosuppressive therapy","ALL","18 Years",{"count":76,"type":77},160,"ESTIMATED","INTERVENTIONAL",[80],"NA","The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between transplant patients on different medication regimens, and their healthy co-habitants. The main questions it aims to answer are:\n\n1. Are there differences in vaccination immunological responses in transplant patients on different immunosuppression regimens?\n2. Are there differences in vaccination immunological responses between transplant patients and their healthy co-habitants? Participants will all receive a 2-dose course of SHINGRIX recombinant Zoster vaccination, and have immunological responses measured and compared at 5 timepoints between 1 week to 1 year post-vaccination.",[83,84],"Immunosuppression","Vaccine Response Impaired","2026-04-06",{"date":87,"type":88},"2026-04-09","ACTUAL",{"date":90,"type":88},"2024-03-20",{"date":92,"type":77},"2027-12",{"name":5,"class":6},1]