[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transplantation-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transplantation-infection":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,53,79,112,139],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100512024","phase-2-high-vsstandard-dose-influenza-vaccine-in-pediatric-solid-organ-transplant-sot-recipients-100512024",false,"NCT05947071","High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients","Comparison of High vs Standard Dose Influenza Vaccines in Pediatric Solid Organ Transplant Recipients","PSOT","Inclusion Criteria:\n\n1. Male or female, 3-17 years of age at time of enrollment\n2. Pediatric kidney, heart, and\u002For liver transplant recipient ≥1 month and \\\u003C24 months post-transplant at the time of study immunization\n\n   * Note: Inclusion of recipients of multiple organs is permitted but is limited to recipients of any combination of organs including kidney, heart and\u002For liver\n   * Note: Participants undergoing re-transplantation are permitted\n3. Anticipated to be available for duration of the study\n4. Available by telephone, email, or text message\n\nExclusion Criteria:\n\n1. Inability (i.e. not able to understand and provide consent) or unwillingness of a participant\u002Fparent\u002Flegal guardian to give written informed consent or comply with study protocol\n2. History of severe hypersensitivity to influenza vaccination or anaphylaxis to eggs\u002Fegg protein\n3. History of severe latex hypersensitivity\n4. History of Guillain-Barre syndrome\n5. History of lung or intestine transplant\n6. HIV positive patients (testing within 24 months of enrollment)\n7. Receipt of current season's influenza vaccine post-transplant prior to enrollment in the study\n8. Currently pregnant or lactating (females of childbearing age may be enrolled based on self-report, urine pregnancy test must be performed prior to each influenza vaccine)\n9. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.","ALL","3 Years","17 Years",{"count":21,"type":22},312,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Influenza virus is a significant pathogen in pediatric solid organ transplant (SOT) recipients. However, these individuals respond poorly to standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. One study compared HD-IIV vs. SD-IIV in adult SOT recipients and noted that HD-IIV was safe and more immunogenic; however, the median post-transplant period was 38 months. A phase I pediatric study comparing a single dose of HD-IIV vs. SD-IIV was safe with higher immunogenicity, but the study was limited by small sample size and median post-transplant vaccine administration was 26 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV one month apart compared to one-dose of SD-IIV revealed modestly increased immunogenicity when given at a median of 18 months post-transplant. Therefore, these studies lack both evaluation in the early post-transplant period and substantive pediatric populations. Additionally, the administration of two-doses of HD-IIV in the same influenza season has not been evaluated in pediatric SOT recipients. Thus, the optimal immunization strategy for pediatric SOT recipients less than 24 months post-transplant is unknown. In addition, immunologic predictors and correlates of influenza vaccine immunogenicity in pediatric SOT recipients have not been well-defined.\n\nThe central hypothesis of our proposal is that pediatric SOT recipients 1-23 months post-transplant who receive two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have similar safety but higher Hemagglutination Inhibition (HAI) geometric mean titers (GMTs) to influenza antigens compared to pediatric SOT recipients receiving two doses of SD-QIV.",[28,29,30],"Immunization; Infection","Transplantation Infection","Influenza",[30,32,33,34,35,36,37,38,39],"Vaccination","Immunization","High Dose","Fluzone","Standard Dose","Influenza, Human","Communicable Diseases","Pediatric transplantation","RECRUITING","2026-04-16",{"date":43,"type":44},"2026-04-21","ACTUAL",{"date":46,"type":44},"2024-09-26",{"date":48,"type":22},"2027-09-01",{"name":50,"class":51},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",8,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100455804","phase-2-high-vs-standard-dose-influenza-vaccine-in-lung-allograft-recipients-100455804","NCT05215327","High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients","Comparison of High Dose vs. Standard Dose Influenza Vaccines in Lung Allograft Recipients","Inclusion Criteria:\n\n1. Lung allograft recipients\n2. Age ≥16 years at time of enrollment\n3. ≥1 month (30 days) and \\\u003C36 months post-lung transplant\n4. Anticipated to be available for duration of the study\n5. Can be reached by telephone, email, or text message\n\nExclusion Criteria:\n\n1. Recipient of multi-organ, extra-pulmonary, and\u002For hematopoietic stem cell transplant\n2. Recipient of a re-do lung transplant\n3. History of severe hypersensitivity to previous influenza vaccination or anaphylaxis to eggs\u002Fegg protein\n4. History of Guillain-Barre syndrome\n5. HIV positive patients, by history or documentation from previous test\n6. History of known severe latex hypersensitivity\n7. History of receiving the current season's influenza vaccine post-transplant prior to enrollment in the study\n8. Pregnant female\n9. Proven influenza disease after September 1st and before first study vaccine (patient can still receive the second influenza vaccination despite proven influenza disease once enrolled)\n10. CMVIG\u002FIVIG\u002FSCIG receipt within 28 days of each vaccine\n11. Receipt of rituximab or other B-cell depleting antibody (including proteasome inhibitors) therapy within 3-months of 1st study vaccine (Day 0).\n12. Receipt of augmented T-cell depleting therapy within 3-months of 1st study vaccine (Day 0)\n13. Investigator concern about study participation","16 Years",{"count":62,"type":22},270,[25],"Lung allograft recipients have a higher burden of influenza disease and greater associated morbidity and mortality compared with healthy controls. Induction and early maintenance immunosuppression is thought to impair immunogenicity to standard dose inactivated influenza vaccine. This early post-transplant period is when immunity is most desirable, since influenza disease during this time frame is associated with adverse consequences. Thus, strategies to reduce severe influenza disease in this highly susceptible population are critical. No trials in lung transplant recipients have evaluated two doses of HD-IIV within the same influenza season as a strategy to improve immunogenicity and durability of influenza prevention. Furthermore, no influenza vaccine trials have focused on enrollment of subjects at early post-transplant timepoints. Very few studies have been performed in solely lung allograft recipients. Immunosuppression intensity is highest in lung patients, thereby limiting comparisons to recipients of heart, liver, and kidney transplants. Therefore, studies to assess both HD-IIV and two-dose strategies in the same influenza season in post-lung transplant recipients are greatly needed.\n\nThe central hypothesis of our proposal is that lung allograft recipients who are 1-35 months post-transplant and receiving two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have higher HAI geometric mean titers (GMT) to influenza antigens compared to those receiving two doses of SD-QIV. To test this hypothesis and address the above critical knowledge gaps, we propose to conduct a phase II, multi-center, randomized, double-blind, controlled immunogenicity and safety trial comparing the administration of two doses of HD-QIV to two doses of SD-QIV in lung allograft recipients 1-35 months post-transplant. The results of this clinical trial will address significant knowledge gaps regarding influenza vaccine strategies (e.g., one vs. two doses and HD-QIV vs. SD-QIV) and immune responses in lung transplant recipients and will guide vaccine recommendations during the post-transplant period.",[28,29,30],[30,32,33,67,34,35,36,37,38],"Lung Transplantation","2025-12-02",{"date":70,"type":44},"2025-12-08",{"date":72,"type":44},"2022-11-08",{"date":74,"type":22},"2027-12-31",{"name":76,"class":77},"Vanderbilt University Medical Center","OTHER",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":97,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":78},"100454517","pharmacokinetics-of-intravenous-acyclovir-in-oncologic-paediatric-patients-100454517","NCT05198570","Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients","Pharmacokinetics of Intravenous Acyclovir in Children Undergoing Hematopoietic Stem Cell Transplantation or High-intensity Antineoplastic Chemotherapy","Inclusion Criteria:\n\n* Patients with Hematological malignancies\n* HSCT recipients who require ACV prophylaxis or treatment for HSV-VZV infection or\n* Children undergoing high-intensity antineoplastic chemotherapy who need ACV treatment.\n* Intravenous or oral ACV dosing\n* Active\u002Favailable a therapeutic drug monitoring (TDM) protocol for ACV\n* Informed consent signed by patient's parents\n\nExclusion Criteria:\n\n* lack of signed informed consent\n* lack of TDM for ACV\n* unavailable patient's demographic characteristics","6 Months","18 Years",{"count":89,"type":22},200,"OBSERVATIONAL","* Herpesvirus infections may be severe in immunocompromised patients, with a high risk of complications and mortality.\n* Recipients of hematopoietic stem cell transplant (HSCT) or patients receiving high-intensity chemotherapy for hematological malignancies are the most vulnerable individuals.\n* Although the worldwide prevalence of herpes simplex virus 1 (HSV-1) and varicella-zoster virus (VZV), antiviral prophylaxis in seropositive HSCT recipients has significantly reduced the rate of infection.\n* Acyclovir (ACV) is the first-choice drug for the prophylaxis or the therapy of that kind of infection.\n* Since the beginning, ACV has demonstrated to be characterized by a large interpatient variability, especially in children.\n* Therefore, therapeutic drug monitoring and pharmacokinetic studies may help in optimizing drug in children with malignancies.",[93,94,95,29,96],"Herpesviridae Infections","Herpes Simplex 1","Varicella Zoster Virus Infection","Oncology",[98,99,100,101,102],"Hematopoietic stem cell transplantation","Herpes virus infections","Aciclovir","Children","Pharmacokinetics","2025-06-02",{"date":105,"type":44},"2025-06-04",{"date":107,"type":44},"2021-09-15",{"date":109,"type":22},"2026-03-31",{"name":111,"class":77},"University of Pisa",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":87,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":78},"100406980","prevalence-and-outcome-of-sars-cov-2-infection--covid-19-in-transplant-recipients-the-covitra-study-100406980","NCT04579471","Prevalence and Outcome of SARS-CoV-2 Infection & COVID-19 in Transplant Recipients: The COVITRA Study","Prevalence and Outcome of SARS-CoV-2 Infection in Solid Organ and Hematopoietic Cell Transplant Recipients: The COVITRA Study","COVITRA","Inclusion Criteria:\n\n* all patients who underwent solid organ or hematopoietic cell transplantation at UZ Leuven and who give informed consent\n\nExclusion Criteria:\n\n* age under 18 years","90 Years",{"count":122,"type":22},2000,"This project will provide novel data using a large cohort of more than 3000 transplanted patients. Risk and protective factors for SARS-CoV-2 infection and COVID-19 disease severity will be identified. The proportion of patients who develop antibodies after infection will be revealed. In this way the presence of these antibodies can be evaluated as a test for prior infection. Our study additionally will demonstrate how long these antibodies remain present and whether they are protective against a new infection.",[125,126,29],"Covid19","SARS-CoV Infection",[128,126,129],"covid19","transplantation","2024-07-02",{"date":132,"type":44},"2024-07-03",{"date":134,"type":44},"2020-07-01",{"date":136,"type":22},"2025-12-31",{"name":138,"class":77},"Universitaire Ziekenhuizen KU Leuven",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":87,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":78},"100172218","molecular-biological-and-moleculargenetic-monitoring-of-therapy-after-kidney-transplantation-100172218","NCT01515605","Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation","MoMoTxRes","Inclusion Criteria:\n\n* Patients after kidney transplantation, male, female, informed consent\n\nExclusion Criteria:\n\n* Deny of informed consent",{"count":147,"type":22},1500,"Molecular monitoring is conducted in blood cells, plasma samples, urine samples and\u002For tissue from patients after kidney transplantation. In the present study the investigators examine the hypothesis that noninvasive diagnostic molecular monitoring can improve the outcome after transplantation.\n\nRoutine clinical and laboratory data from serum and urine are evaluated at baseline and after 0-1-2-3-4-12-16-52 weeks and 1-2-3-4-5-6-7-8-9-10 years after kidney transplantation. Mononuclear cells were obtained from the blood and transcripts of several diagnostic genes (including GATA3 (Trans-acting T-cell-specific transcription factor3), GATA4 (Trans-acting T-cell-specific transcription factor4), GAPDH (Glyceraldehyde 3-phosphate dehydrogenase), TRPC3 (Transient receptor potential cononical type3), TRPC6 (Transient receptor potential cononical type6), granzyme B, perforin, FOXP3 (Forkhead box P3), ISG15 (Interferon-stimulated gene 15), Mx1 (Interferon-induced GTP-binding protein), MMP3 (Matrix metalloproteinase-3), MMP9 (Matrix metalloproteinase-9), long-non-coding RNA, and others) are quantified using standard quantitative RT-PCR (Reverse transcription polymerase chain reaction) techniques. Proteomic analysis were performed in plasma and urine samples. Polymorphisms of selected genes are analyzed using standard techniques. Data are analyzed by descriptive statistics. Differences between groups were analyzed using Mann-Whitney test or Kruskal-Wallis-test and Dunn's multiple comparison post-test, as appropriate. Associations between variables are analyzed using regression analyses. Contingency tables are analyzed using Fisher's exact test.",[29,150],"Kidney Diseases","2023-03-25",{"date":153,"type":44},"2023-03-28",{"date":155,"type":44},"2011-01-01",{"date":157,"type":22},"2033-03-31",{"name":159,"class":77},"Odense University Hospital"]