[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627059":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":56,"collaborators":12,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":12,"enrollmentInfo":70,"targetDuration":12,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":82,"whyStopped":12,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University of Lausanne Hospitals","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control (no booster)","NO_INTERVENTION","Control participants will not receive an injection but will undergo blood sampling at the same time points as the experimental group - baseline (pre-randomization), and at 1, 6 and 12 months - to ensure comparability of immunological data. They will continue standard post-transplant care and routine clinical follow-up according to institutional practice.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"RZV booster","EXPERIMENTAL","The intervention group will receive a RZV booster dose. Vaccine reconstitution will follow the manufacturer's instructions immediately before injection.\n\nAdministration will be performed by a trained study nurse or investigator under medical supervision. Participants will be observed for at least 15 minutes post-injection to detect any immediate hypersensitivity or vasovagal reaction.\n\nNo deviation from the commercial formulation or packaging is expected. The IMP used in this trial is identical to the marketed product authorized in Switzerland and the EU.",[18],"Biological: Booster dose of the recombinant zoster vaccine (RZV, Shingrix®)",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"BIOLOGICAL","Booster dose of the recombinant zoster vaccine (RZV, Shingrix®)","Participants randomized to the intervention arm will receive a single intramuscular injection of Shingrix® (0.5 mL recombinant glycoprotein E antigen with AS01B adjuvant) administered into the deltoid muscle. The booster will be administered at least 6 months after transplantation. Vaccine supply, storage (2-8°C), and accountability will be managed by the hospital pharmacy according to GCP standards.",[14],[26],{"name":27,"affiliation":28,"role":29},"Oriol Manuel, MD","Service des maladies infectieuses, Centre hospitalier universitaire vaudois (CHUV)","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":12,"email":34},"CONTACT","+41 79 556 61 36","oriol.manuel@chuv.ch",{"name":36,"role":32,"phone":37,"phoneExt":12,"email":38},"Elise Pickavance, MSc","+41 79 556 33 86","elise.pickavance@chuv.ch",[40],{"facility":41,"status":12,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Lausanne University Hospital","Lausanne","Canton of Vaud","1011","Switzerland","CH",{"type":48,"coordinates":49},"Point",[50,51],6.63282,46.516,{"lat":51,"lon":50},[54],{"name":36,"role":32,"phone":55,"phoneExt":12,"email":38},"+41 79 556 3386",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Oriol Manuel","Associated Professor","100627059","phase-2-zoster-vaccine-to-enhance-protection-against-zoster-in-solid-organ-transplantation-100627059",false,"NCT07443709","Zoster Vaccine to Enhance Protection Against Zoster in Solid-organ Transplantation","A Single-centre Open-label Parallel Two-arms Pilot Randomized Clinical Trial of a Booster Recombinant Zoster Vaccine in Solid-Organ Transplant Recipients","ZEST","Inclusion Criteria:\n\n* Aged ≥18 years\n* SOT recipient who has received two doses of the Shingrix® vaccine (primary vaccination).\n* At least 6 months after transplantation\n* At least 6 months after the completion of the Shingrix® primary vaccination series.\n* At least 8 weeks have elapsed since any treated episode of acute allograft rejection or At least 6 months if B-cell depleting antibodies (e.g. rituximab, alemtuzumab) was used as part of the treatment.\n* Signature of the written informed consent.\n\nExclusion Criteria:\n\n* Acute febrile illness or active infection at the time of enrolment, as determined by the investigator (patients can be enrolled in a later stage).\n* Known hypersensitivity to any component of RZV.\n* Willing to become pregnant","ALL","18 Years",{"count":71,"type":72},75,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","Shingles is caused by the same virus that causes chickenpox. After someone has chickenpox, the virus stays in the body and can become active again later in life. This is called shingles.\n\nPeople who have received a solid organ transplant (such as a kidney, liver, or heart transplant) are 3 to 10 times more likely to get shingles than the general population. In transplant patients, shingles is often more severe. It can spread to other parts of the body and may cause long-lasting nerve pain. These problems can lower quality of life, increase doctor visits and hospital care, and may even affect how well the transplanted organ works.\n\nThe shingles vaccine called Shingrix® (recombinant zoster vaccine, RZV) works well in healthy adults and is generally safe for transplant patients. However, about 30% of transplant recipients still develop shingles even after receiving the recommended two doses. This may be because their immune system is weakened by the long-term medicines they take to prevent organ rejection.\n\nThe purpose of this clinical trial is to find out whether giving an extra (booster) dose of the shingles vaccine after transplant can improve the immune response in solid organ transplant recipients.\n\nThis study aims to answer the following questions:\n\n* How many participants have at least twice as many shingles antibodies (anti-gE antibodies) four weeks after receiving the booster compared to before the booster?\n* How strong and how long does the immune response last at 6 and 12 months?\n* Is the booster dose safe for transplant patients? In this study, researchers will compare two groups: One group will receive a booster dose of the shingles vaccine. The other group will not receive the booster. They will compare the groups to see differences in immune response, cases of shingles despite vaccination, and any side effects.\n\nParticipants in the study will:\n\n* Be randomly assigned (by chance) in a 2:1 ratio to either receive the booster or not.\n* Have blood samples taken at the first visit, and again at 1 month, 6 months, and 12 months to measure antibody levels and immune responses.\n* Be monitored for any possible side effects.\n* Have their medical records reviewed for health events such as side effects or organ rejection.",[78],"Zoster; Herpes",[80,81],"Solid Organ Transplant (SOT) Recipients","recombinant zoster vaccine","NOT_YET_RECRUITING","2026-02-24",{"date":85,"type":86},"2026-03-02","ACTUAL",{"date":88,"type":72},"2026-04",{"date":90,"type":72},"2027-04",{"name":58,"class":6},1]