Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-29 @ 11:10 PM
Study NCT ID:
NCT04815850
Status:
COMPLETED
Last Update Posted:
2024-09-26
First Post:
2021-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phenotyping Seroconversion Following Vaccination Against COVID-19 in Patients on Haemodialysis Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D006679', 'term': 'HIV Seropositivity'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D018352', 'term': 'Coronavirus Infections'}, {'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'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mgb23@le.ac.uk', 'phone': '01162588043', 'title': 'Dr Matthew Graham-Brown', 'organization': 'University of Leicester'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '10 months', 'description': 'This is an observational study. There were no adverse events related to the study procedures which involved blood samples and questionnaires.', 'eventGroups': [{'id': 'EG000', 'title': 'Patients on Haemodialysis', 'description': 'Patients receiving haemodialysis', 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 0, 'seriousNumAtRisk': 94, 'deathsNumAffected': 29, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in COVID-19 IgG Antibody (Relative Light Units)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients on Haemodialysis', 'description': 'Patients receiving haemodialysis'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '8.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 month post first vaccine', 'description': 'Measured from a serum blood sample. Serum was tested for the presence of SARS-CoV-2 neutralising IgG and IgM antibodies directed against the receptor binding domain of the S1 spike protein, using the Siemens ADVIA Centaur XP/XPT assay and reported as positive or negative as per manufacturer guidelines (detectable antibody levels \\>1RLU (relative light units) reported as positive to an upper limit of 10)', 'unitOfMeasure': 'relative light unit (RLU)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients on Haemodialysis', 'description': 'Patients receiving haemodialysis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients on Haemodialysis', 'description': 'Patients receiving haemodialysis'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '62.1', 'spread': '12.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-03', 'size': 528431, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-13T10:22', 'hasProtocol': True}, {'date': '2021-04-01', 'size': 101779, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-23T04:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-23', 'studyFirstSubmitDate': '2021-03-23', 'resultsFirstSubmitDate': '2023-12-01', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-23', 'studyFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in COVID-19 IgG Antibody (Relative Light Units)', 'timeFrame': '1 month post first vaccine', 'description': 'Measured from a serum blood sample. Serum was tested for the presence of SARS-CoV-2 neutralising IgG and IgM antibodies directed against the receptor binding domain of the S1 spike protein, using the Siemens ADVIA Centaur XP/XPT assay and reported as positive or negative as per manufacturer guidelines (detectable antibody levels \\>1RLU (relative light units) reported as positive to an upper limit of 10)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['haemodialysis', 'COVID-19', 'seroconversion', 'chronic kidney disease'], 'conditions': ['End Stage Kidney Disease']}, 'descriptionModule': {'briefSummary': 'Patients on haemodialysis are at higher risk of getting a severe form of COVID-19 if they become infected. Vaccinations are soon to arrive and offer great hope of controlling the current pandemic. It is likely that patients on haemodialysis will be amongst the first people to be offered vaccination against COVID-19 when they become available. While any vaccines offered to these patients will be safe to receive, the effectiveness of the vaccines at giving immunity to being infected with COVID-19 are not known as they have not been explicitly tested in patients on haemodialysis. This study will involve having 3 blood tests to test for an antibody response following vaccination for COVID-19. The first will be 1 month after the first vaccination dose to look at the initial antibody response and the second and third will be 1 month and 6 months after the second vaccination dose.', 'detailedDescription': 'Patients with end stage kidney disease (ESKD) on haemodialysis are more likely to suffer poorer outcomes following infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. This is likely to be because these patients have higher levels of co-morbid diseases and they are relatively immunosuppressed due to the effects of advanced kidney disease. The humoral response against common viral vaccination is known to be blunted in patients with ESKD and there are data to suggest seroconversion following infection with COVID-19 is blunted in patients with kidney disease. A successful programme of vaccination will undoubtedly improve outcomes for patients on haemodialysis, but vaccine testing programmes have not included patients with ESKD. Whilst initial press-coverage of the efficacy of vaccines which are available for use is promising, they are untested in patients on haemodialysis who are known to be relatively immunosuppressed as a result of their renal disease and as such the efficacy for this patient group is not known.\n\nThis study will phenotype the IgG antibody response to vaccination for COVID-19 in 100 patients on haemodialysis compared to 50 healthy volunteers. Antibody testing will be conducted at 1 month post first vaccination dose and 1 month and 6 months post second vaccination dose. This will give crucial information as to the efficacy of the vaccine and inform possible requirements for re-vaccination.\n\nThis study will:\n\n1. Phenotype the 1 month IgG antibody response to the first vaccination dose and the 1 month and 6 month response to the second vaccination dose for COVID-19 in patients on haemodialysis\n2. Compare the 1 month IgG antibody response to the first vaccination dose and the 1 month and 6 month response to the second vaccination dose for COVID-19 between patients on haemodialysis and healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving haemodialysis at Leicester General Hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* End stage kidney disease on haemodialysis\n* Able and willing to give informed consent\n* Have completed or due to complete vaccination against COVID-19\n\nExclusion Criteria:\n\n* Acute kidney injury requiring temporary haemodialysis\n* Unable to give informed consent\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04815850', 'briefTitle': 'Phenotyping Seroconversion Following Vaccination Against COVID-19 in Patients on Haemodialysis Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Leicester'}, 'officialTitle': 'Phenotyping Seroconversion Following Vaccination Against COVID-19 in Patients on Haemodialysis Study', 'orgStudyIdInfo': {'id': '0810'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients on haemodialysis', 'description': 'Patients receiving haemodialysis'}, {'label': 'Healthy controls', 'description': 'Participants with no chronic kidney disease or history of immunosuppression'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LE5 4PW', 'city': 'Leicester', 'state': 'Leicestershire', 'country': 'United Kingdom', 'facility': 'University Hospital Leicester NHS Trust', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}], 'overallOfficials': [{'name': 'Matthew PM Graham-Brown', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leicester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leicester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Leicester Hospitals Charity', 'class': 'OTHER'}, {'name': 'Francis Crick Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}