[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498858":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":39,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":37,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":37,"overallStatus":42,"whyStopped":37,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"1-\u003C2 years post stem cell transplant","EXPERIMENTAL","At Visit 1 participants will be given information about the nature of HZ and its recognition and given a questionnaire for completion should they develop HZ during the study. They will also be asked to contact the study team if they develop HZ so that further evaluation of potential HZ is completed and the details of the event recorded. A swab of an active lesion or crust from a dried lesion will be obtained for VZV PCR. A participant who develops HZ will be asked to complete the questionnaire weekly for 4 weeks and then at 8 and 12 weeks. In addition, the subject will be asked about pain medications taken during the episode. Information on HZ incidence will be supplemented from the clinic medical records and the electronic medical records. Subjects will be followed for 1 year after enrollment for the occurrence of HZ and of post-herpetic neuralgia (PHN).",[13],"Drug: Zoster Vaccine Recombinant",{"label":15,"type":10,"description":11,"interventionNames":16},"2-\u003C3 years post stem cell transplant",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"≥ 3 years post stem cell transplant",[13],[21],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Zoster Vaccine Recombinant","Injection",[9,15,18],[27],"Shingrix",[29],{"name":30,"affiliation":5,"role":31},"Myron Levin, MD","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Tori Rutherford, RN BSN","CONTACT","303-724-2454",null,"tori.rutherford@childrenscolorado.org",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University of Colorado Hospital","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-104.83192,39.72943,{"lat":52,"lon":51},[55,56],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},{"name":57,"role":58,"phone":37,"phoneExt":37,"email":37},"Jonathan Gutman, MD","SUB_INVESTIGATOR",{"type":60,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[62],{"name":63,"class":64},"GlaxoSmithKline","INDUSTRY","100498858","phase-2-shingrix-in-recipients-of-allogeneic-transplants-100498858",false,"NCT05775718","Shingrix In Recipients of Allogeneic Transplants","Safety and Immunogenicity of Shingrix Administered to Recipients of Allogeneic Peripheral and Cord Blood Stem Cell Transplants: Effect of Timing of Vaccination After Transplantation","Allo","Inclusion Criteria:\n\n* Allo-SCT recipients being age 18 - 79 years at time of allo-SCT.\n* Written informed consent being obtained from the subject\n* Two doses of RZV, separated by 2 to 6 months, administered at least 1 year after allo-SCT.\n* Enrollment at \\>\u002F= 18 months after second dose of Shingrix.\n* Female subjects of childbearing potential (FOCBP) enrolled in the study only if they:\n\n  * have practiced adequate contraception for 30 days prior to vaccination with any dose of zoster vaccine and\n  * have a negative pregnancy test on the day of each dose of zoster vaccine and\n  * agree to continue adequate contraception during the vaccination period and for 2 months after receipt of the vaccine.\n* Investigator belief that the participant will comply with the requirements of the protocol\n\nExclusion Criteria:\n\n* Active Graft Versus Host Disease (aGVHD) at the time of enrollment and receipt of the third dose of RZV\n* Having received ≥20 mg prednisone for more than 2 weeks (or equivalent) in the 8 weeks preceding enrollment.\n* Receiving any significant immunosuppressive therapy other than for graft maintenance, in the opinion of the investigator.\n* Having received a live attenuated vaccine within the last 4 weeks, or inactivated vaccine in the last 2 weeks, prior to enrollment.\n* Having a history of HZ after the administration of the primary 2-dose RZV immunization regimen.\n* Pregnancy or breastfeeding\n* Receiving investigational drugs from 30 day before enrollment or planned during the study\n* Inability of participants unable to comply with the study schedule in the opinion of the investigator","ALL","18 Years","79 Years",{"count":77,"type":78},55,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","This research is designed to determine if the adjuvanted recombinant glycoprotein E (gE) herpes zoster (HZ) vaccine (Shingrix) has acceptable immunogenicity and safety in people who have undergone allogeneic stem cell transplant (allo-SCT). Specifically, it will determine the effect of the interval after transplantation on the immune response and if an additional dose of vaccine is needed to improve the vaccine-induced responses.",[84,85],"Bone Marrow Transplant","Stem Cell Transplant","2026-02-02",{"date":88,"type":89},"2026-02-05","ACTUAL",{"date":91,"type":89},"2023-10-24",{"date":93,"type":78},"2030-12-01",{"name":5,"class":6},1]