[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637138":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":42,"centralContacts":47,"locations":56,"responsibleParty":103,"collaborators":42,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":116,"maxAge":42,"enrollmentInfo":117,"targetDuration":42,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":128,"overallStatus":135,"whyStopped":42,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Central Adelaide Local Health Network Incorporated","OTHER_GOV",[8,15,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","Influenza and RSV vaccination without additional treatment",[13,14],"Biological: Influenza vaccine (Sequiris Fluad Quad)","Biological: RSV vaccine (Pfizer Abrysvo)",{"label":16,"type":17,"description":18,"interventionNames":19},"Pre-vaccine sirolimus group","EXPERIMENTAL","Sirolimus 2mg orally x3\u002Fweek on haemodialysis for 3 weeks. Influenza and RSV vaccination 2 weeks after completing sirolimus course.",[20,13,14],"Drug: Sirolimus (RAPAMUNE)",{"label":22,"type":17,"description":23,"interventionNames":24},"Peri-vaccine sirolimus group","Sirolimus 2mg orally x3\u002Fweek on haemodialysis for 3 weeks. Influenza and RSV vaccination 1 week after commencing sirolimus course.",[20,13,14],{"label":26,"type":17,"description":27,"interventionNames":28},"Post-vaccine sirolimus group","Sirolimus 2mg orally x3\u002Fweek on haemodialysis for 3 weeks. Influenza and RSV vaccination 2 weeks prior to commencing sirolimus course.",[20,13,14],[30,37,43],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Sirolimus (RAPAMUNE)","All treatment groups will receive 9 doses of 2mg sirolimus over a 3 week period, at varying times relative to vaccination.",[22,26,16],[36],"Rapamycin",{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"BIOLOGICAL","Influenza vaccine (Sequiris Fluad Quad)","All participants will receive a dose of the seasonal Influenza vaccine (Sequiris Fluad Quad)",[9,22,26,16],null,{"type":38,"name":44,"description":45,"armGroupLabels":46,"otherNames":42},"RSV vaccine (Pfizer Abrysvo)","All participants will receive a dose of the RSV vaccine (Pfizer Abrysvo)",[9,22,26,16],[48,53],{"name":49,"role":50,"phone":51,"phoneExt":42,"email":52},"Toby Coates, MBBS FRACP PhD","CONTACT","(08) 7074 0000","Toby.Coates@sa.gov.au",{"name":54,"role":50,"phone":42,"phoneExt":42,"email":55},"Griffith Perkins, BSc PhD","Griffith.Perkins@adelaide.edu.au",[57,75,90],{"facility":58,"status":42,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Royal Prince Alfred Hospital","Camperdown","New South Wales","2050","Australia","AU",{"type":65,"coordinates":66},"Point",[67,68],151.17642,-33.88965,{"lat":68,"lon":67},[71],{"name":72,"role":50,"phone":73,"phoneExt":42,"email":74},"Steve Chadban, MBBS PhD FRACP","(02) 9515 6111","Steve.Chadban@health.nsw.gov.au",{"facility":76,"status":42,"city":77,"state":78,"zip":79,"country":62,"countryCode":63,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Princess Alexandra Hospital","Woolloongabba","Queensland","4102",{"type":65,"coordinates":81},[82,83],153.03655,-27.48855,{"lat":83,"lon":82},[86],{"name":87,"role":50,"phone":88,"phoneExt":42,"email":89},"Matthew Tunbridge, MBBS FRACP","(07) 3176 2111","Matthew.Tunbridge@health.qld.gov.au",{"facility":91,"status":42,"city":92,"state":93,"zip":94,"country":62,"countryCode":63,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Royal Adelaide Hospital","Adelaide","South Australia","5000",{"type":65,"coordinates":96},[97,98],138.59863,-34.92866,{"lat":98,"lon":97},[101],{"name":102,"role":50,"phone":51,"phoneExt":42,"email":52},"Toby Coates, MBBS PhD FRACP",{"type":104,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"PRINCIPAL_INVESTIGATOR","Matthew Tunbridge","Doctor","100637138","phase-2-vaccination-response-modulation-with-a-targeted-rapamycin-protocol-study-100637138",false,"NCT07587801","Vaccination Response Modulation With a Targeted Rapamycin Protocol Study","Vaccination Response Modulation With a Targeted Rapamycin Protocol (VON TRAPP) Study","VON TRAPP","Inclusion Criteria:\n\n* End-stage kidney disease requiring in-centre haemodialysis three times per week as kidney replacement therapy\n* Aged \\>60 years\n\nExclusion Criteria:\n\n* Aged \\\u003C60 years\n* Alternative haemodialysis regimens (e.g. twice-weekly haemodialysis, second-daily home haemodialysis)\n* Recent infection (\\\u003C6 months) with proven Influenza A, Influenza B, or RSV\n* Current use of immunosuppressive medications, including:\n\n  * Oral steroid at a dose equivalent of 5 mg\u002Fday prednisolone or greater\n  * Mycophenolate mofetil\n  * Azathioprine\n  * Calcineurin inhibitors\n  * mTOR inhibitors\n* Recent use of intravenous immunosuppressive medications (\\\u003C6 months), including:\n\n  * T-cell depleting agents (e.g. anti-thymocyte globulin)\n  * B-cell depleting agents (e.g. rituximab)\n  * Cyclophosphamide\n* Has a history of problems with side-effects associated with sirolimus use including\n\n  * Angioedema\n  * Active\u002Frecent opportunistic infection\n  * Current or prior interstitial lung disease, non-infectious pneumonitis, organising pneumonia, or pulmonary fibrosis\n  * Clinically significant pleural effusion or pericardial effusion\n  * Active non-healing wounds, chronic skin ulcers, or planned major surgery\u002Fprocedures\n  * Current malignancy or recent malignancy with high recurrence risk\n  * Severe or uncontrolled hyperlipidaemia\n  * History of rhabdomyolysis\n  * Severe hepatic impairment\n* Ongoing use of strong CYP3A4\u002FP-gp inhibitors or inducers including\n\n  * Inhibitors: Ketoconazole, Voriconazole, Itraconazole, Telithromycin, Clarithromycin\n  * Inducers: Rifampicin, Rifabutin\n* Unable or unwilling to provide informed consent to participate in the trial\n* Known allergy to or intolerance of sirolimus (rapamycin) or the contents of the influenza or RSV vaccine","ALL","60 Years",{"count":118,"type":119},60,"ESTIMATED","INTERVENTIONAL",[122],"PHASE2","This study will investigate dialysis recipients' responses to important vaccines.\n\nResearch suggests that a medication commonly used by transplant recipients may improve vaccine responses. The investigators will be conducting a clinical trial to see whether a short course of low-dose Sirolimus improves the response to vaccination against respiratory syncytial virus (RSV) and influenza (flu) in patient with kidney disease over 60 years old who receive haemodialysis.",[125,126,127],"Vaccine Immune Response","Haemodialysis Patients","Older Adults",[129,130,131,132,133,134],"influenza","RSV","vaccine","haemodialysis","older adults","immunosenescence","NOT_YET_RECRUITING","2026-05-11",{"date":138,"type":139},"2026-05-14","ACTUAL",{"date":141,"type":119},"2026-05",{"date":143,"type":119},"2026-07",{"name":5,"class":6},3]