[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-organ-transplant-recipients\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-organ-transplant-recipients":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100592748","phase-1-phase-i-trial-on-the-safety-of-delayed-infusion-of-a-nave-t-cell-depleted-hematopoietic-graft-with-memory-t-cells-in-solid-organ-transplant-recipients-100592748",false,"NCT06997471","Phase I Trial on the Safety of Delayed Infusion of a Naïve T Cell-Depleted Hematopoietic Graft With Memory T Cells in Solid Organ Transplant Recipients","A Phase I, Single-Center, Open-Label Trial to Assess the Safety and Tolerability of Delayed Infusion of a Naïve T Cell Depleted Hematopoietic Graft and Memory T-lymphocytes in Recipients of Solid Organ Transplantation","DUALGRAFT","Inclusion Criteria:\n\n* Pediatric patients (\\\u003C18 years old) who are candidates to receive intestinal or lung transplantation (before SOT).\n* Pediatric (\\\u003C18 years old) or adult patients (≥18 years old) who are either candidates for renal transplantation or have already undergone renal transplantation and remain candidates for subsequent HSCT.\n* Patients who provide informed consent (or their legal guardians in the case of minors) before any study-related procedures.\n* Recipients should have no active infectious disease or other medical condition that would contraindicate the combined transplantation procedure, as determined by the investigational team.\n\nExclusion Criteria:\n\n* Recipients with existing bone marrow disorders or those receiving medications known to adversely affect bone marrow function.\n* Patients with advanced organ dysfunction (hepatic, cardiac, or pulmonary) incompatible with successful combined transplantation.\n* Patients with active or uncontrolled autoimmune conditions that may interfere with transplantation and the induction of chimerism.\n* Patients with known allergies to medications or products required for conditioning or transplantation.\n* Patients with severe psychiatric or cognitive disorders that may interfere with adherence to study instructions or postoperative care.\n* Patients currently enrolled in another clinical trial that could interfere with the outcomes or safety of this study.\n* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.\n* Any other condition that, in the opinion if the Investigator, may interfere with the efficacy and\u002For safety evaluation of the trial.","ALL","0 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this clinical trial is to evaluate the safety and feasibility of inducing hematopoietic mixed chimerism to promote immune tolerance and potentially reduce the need for lifelong immunosuppression in pediatric and adult patients undergoing solid organ transplantation (SOT), including kidney, lung, and multivisceral transplants.\n\nThe main questions it aims to answer are:\n\n* Is it safe to infuse a naïve T cell-depleted hematopoietic graft along with memory T-lymphocytes after SOT?\n* Can this approach support immune tolerance and reduce the incidence of rejection and infection without long-term immunosuppression?\n\nParticipants will:\n\n* Undergo a solid organ transplant from a living or deceased donor.\n* Wait through a stabilization period to ensure resolution of early transplant-related complications.\n* Receive low-dose preconditioning (TLI and thymic irradiation) to prepare for hematopoietic stem cell transplantation.\n* Be infused with a graft containing CD34+ progenitor cells, memory T cells (CD45RO+), and no naïve T cells (CD45RA+); in some cases, NK cells may also be included.\n* Be followed for graft survival, immune tolerance, infection rates, and adverse events through regular clinical and immune monitoring visits.",[27,28,29],"Solid Organ Transplant Complications","Solid Organ Transplant Recipients","Solid Organ Transplant Rejection","RECRUITING","2026-05-04",{"date":33,"type":34},"2026-05-08","ACTUAL",{"date":36,"type":34},"2025-06-10",{"date":38,"type":21},"2028-06",{"name":40,"class":41},"Francisco Hernández Oliveros","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":65,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100562168","phase-2-covid-19-booster-and-iiv-schedule-in-immunocompromised-hosts-100562168","NCT06599658","COVID-19 Booster and IIV Schedule in Immunocompromised Hosts","The Immunogenicity and Safety of COVID-19 and Influenza Vaccine Co-administration and Interval in Immunocompromised Hosts","CO2I2","Inclusion Criteria:\n\n\\- All participants must meet ALL the following inclusion criteria: i. Adults (≥18 years) ii. Received the primary mRNA COVID-19 vaccine series (i.e., ≥3 doses) iii. Have at least one of the following immunocompromising conditions:\n\na) Received a solid organ transplant (SOT) ≥3-months ago, and treated with a conventional maintenance immunosuppression regimen; b) People living with HIV (PLWH) receiving ART for ≥6 months who meet at least one of the following conditions: i) AIDS-defining illness in the last 6 months, ii) TB diagnosis in the last 6-months, iii) CD4\\<200 cells\u002FµL in the last 6 months, iv) CD4%\\<15% in the last 6 months, or v) absence of HIV viral suppression in the last 6 months; c) Inflammatory bowel disease (IBD) treated with a conventional or biologic immunosuppressive agent for ≥3 months; d) Rheumatoid arthritis or systemic lupus erythematosus (herein referred to as rheumatological disease (RD)) treated with a conventional or biologic immunosuppressive agent for ≥3 months.\n\nExclusion Criteria:\n\n* Potential participants who meet ANY of the following criteria will be excluded:\n\n  i. Received any of the following:\n  1. Annual vaccination against influenza \\< 6 months ago\n  2. COVID-19 booster \\< 3 months ago ii. History of any of the following:\n\n  \u003C!-- -->\n\n  1. life-threatening reaction any component of the IIV or COVID-19 vaccines\n  2. Guillain-Barre syndrome or myocarditis within 6 weeks of a previous influenza or COVID-19 vaccination\n  3. Contraindication to intramuscular vaccines such as bleeding disorder, severe thrombocytopenia, etc; iii. Receiving intravenous immunoglobulins; iv. Have underlying primary inborn errors of immunity; v. Receiving chemotherapy such as cyclophosphamide \\< 6-months ago; vi. Unable to provide informed consent","18 Years",{"count":53,"type":21},660,[55],"PHASE2","The goal of this pragmatic embedded open-label, 2 x 2 factorial phase II randomized controlled trial is to evaluate strategies to improve COVID-19 booster and influenza vaccine immunogenicity in people living with immunocompromising conditions (PLIC).\n\nThe main questions it aims to answer are:\n\n1. Is co-administration of seasonal inactivated influenza vaccine (IIV) with the most up-to-date recommended COVID-19 booster dose non-inferior in inducing a 1-month peak protective humoral response against COVID-19, compared to a strategy of sequential administration of COVID-19 booster dose followed by seasonal IIV given one month later?\n2. Is the administration of the most up-to-date recommended COVID-19 booster doses at 3-month intervals superior at maintaining a longer term protective humoral immune response, compared to booster doses administered at 6-month intervals?\n\nResearchers will compare (1) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 3-month interval, (2) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 3-month interval, (3) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 6-month interval, and (4) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 6-month interval to see if median neutralization capacity of patient sera is non-inferior in the co- vs. sequential administration arms at 1-month after the initial COVID-19 booster and superior in the 3-month interval arms vs. the 6-month interval arms at 12 months after the initial COVID-19 booster. These outcomes will also be compared at 2-months for question 1 and 6-months for question 2.\n\nPeople living with immunocompromising conditions who take part in the trial will have blood samples drawn to verify immune response, be monitored for changes in clinical events and therapies, and complete questionnaires to verify adverse effects, quality of life and economic impact.",[58,59,60,61,62,28,63,64],"COVID 19","Influenza","Rheumatoid Arthritis (RA)","Systemic Lupus Erthematosus","Inflammatory Bowel Disease","Immunocompromised Host","People Living With HIV",[66,67,68],"Vaccine","Immunogenicity","Safety","2026-03-06",{"date":71,"type":34},"2026-03-10",{"date":73,"type":34},"2024-11-20",{"date":75,"type":21},"2027-03-31",{"name":77,"class":41},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",3]