Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-31 @ 8:00 PM
Study NCT ID:
NCT05051605
Status:
UNKNOWN
Last Update Posted:
2023-02-14
First Post:
2021-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Response to COVID-19 Vaccine in Recipients of Living Donor Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086663', 'term': 'COVID-19 Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-11', 'studyFirstSubmitDate': '2021-09-17', 'studyFirstSubmitQcDate': '2021-09-17', 'lastUpdatePostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neutralizing antibody titer change 14 days after vaccination compared to baseline', 'timeFrame': 'At baseline, at 14 days after whole course of vaccination', 'description': 'neutralizing antibody response to SARS-CoV-2 vaccine in recipients post living donor liver transplantation'}, {'measure': 'Neutralizing antibody titer change 28 days post vaccination compared to baseline', 'timeFrame': 'At baseline and 28 days after whole course of vaccination', 'description': 'neutralizing antibody response to SARS-CoV-2 vaccine in recipients post living donor liver transplantation'}], 'secondaryOutcomes': [{'measure': 'Interleukin-6 serum level', 'timeFrame': 'At baseline, at 14 and 28 days after whole course of vaccination', 'description': 'Assessing the cellular immunological response to SARS-CoV-2 vaccine in recipients post living donor liver transplantation'}, {'measure': 'Incidence of confirmed coronavirus disease', 'timeFrame': '28 days after whole course of vaccination', 'description': 'Patient follow-up for confirmed symptomatic infection by SARS-COV2 virus'}, {'measure': 'Incidence of adverse events related to vaccine', 'timeFrame': '7 days after each dose of the vaccine and up to 28 days after last vaccine dose administered', 'description': 'Self reported safety and tolerability of vaccine'}, {'measure': 'Incidence of acute graft rejection', 'timeFrame': 'On 14 and 28 days post whole course vaccination', 'description': 'Follow-up for signs and symptoms of graft rejection'}, {'measure': 'Immune response correlation to HLA DRB1 genetic polymorphism', 'timeFrame': '28 days post whole course vaccination', 'description': 'TaqMan®️ SNP genotyping assay of HLA DRB1 gene (rs2647087)'}, {'measure': 'Immune response correlation to IL-18 genetic polymorphism', 'timeFrame': '28 days post whole course vaccination', 'description': 'TaqMan®️ SNP genotyping assay of IL-18 gene (rs187238 and rs917997)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver', 'transplantation', 'COVID-19', 'Coronavirus', 'Vaccine'], 'conditions': ['Liver Transplant']}, 'descriptionModule': {'briefSummary': 'A prospective cohort study to evaluate the response to COVID-19 vaccine in liver transplantation patients.', 'detailedDescription': 'fifty living donor liver transplantation recipients during maintenance immunosuppression phase will be vaccinated against COVID-19 followed by assessment of immune response to the vaccine and further investigation of correlation of immune response to genetic polymorphisms of HLA DRB1(rs2647087) gene and IL-18 (rs187238 and rs917997) gene.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Living donor liver transplantation recipients willing to be vaccinated against COVID-19 and capable of signing an informed consent to participate in this cohort', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18\n* At least 3 month post transplantation\n\nExclusion Criteria:\n\n* pediatric recipients\n* Active covid infection at the time of the study\n* Pregnancy\n* Allergy to any ingredients included in the vaccine\n* Lactation in first six month of delivery\n* Active Acute cellular rejection proven by liver biopsy\n* Acute Febrile state with either leucopenia or leucocytosis\n* High dose of corticosteroid at study timing (pulse methyl prednisolone)'}, 'identificationModule': {'nctId': 'NCT05051605', 'briefTitle': 'Immune Response to COVID-19 Vaccine in Recipients of Living Donor Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Evaluation of the Immune Response to COVID-19 Vaccine in Recipients of Living Donor Liver Transplantation', 'orgStudyIdInfo': {'id': 'RHDIRB2020110301 REC 45'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vaccinated group', 'description': 'Fifty living donor liver transplantation recipients on maintenance immunosuppressive regimen who would receive COVID-19 vaccine at least 3 months postoperatively.', 'interventionNames': ['Biological: COVID-19 Vaccine']}], 'interventions': [{'name': 'COVID-19 Vaccine', 'type': 'BIOLOGICAL', 'description': 'Severe acute respiratory syndrome- coronavirus-2 (SARS-CoV-2)vaccine according to vaccine availability in the Egyptian ministry of health.', 'armGroupLabels': ['Vaccinated group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11765', 'city': 'Cairo', 'state': 'Please Select Region, State Or Province', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Rana Sayed, PhD', 'role': 'CONTACT', 'email': 'ranasayed@pharma.asu.edu.eg', 'phone': '01208164247', 'phoneExt': '+2'}], 'facility': 'Ain Shams center for organ transplantation (ASCOT), Ain shams university specialized hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Rana Sayed, PhD', 'role': 'CONTACT', 'email': 'ranasayed@pharma.asu.edu.eg', 'phone': '01208164247', 'phoneExt': '+2'}, {'name': 'Sara Alaa, Msc', 'role': 'CONTACT', 'email': 'Sarah_alaaosman52@hotmail.com', 'phone': '01112119264', 'phoneExt': '+2'}], 'overallOfficials': [{'name': 'Rana Sayed, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Pharmacy, Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Rana Sayed Fouad', 'investigatorAffiliation': 'Ain Shams University'}}}}