Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT04805632
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2021-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immune Response in Dialysis Patients Vaccinated Against COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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': '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2021-03-16', 'studyFirstSubmitQcDate': '2021-03-16', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Humoral response to vaccination against against SARS-CoV-2 as compared to controls', 'timeFrame': '28 days after the second vaccination', 'description': 'SARS-CoV2 IgG levels'}], 'secondaryOutcomes': [{'measure': 'Humoral response to vaccination against against SARS-CoV-2', 'timeFrame': '22 weeks after the second vaccination', 'description': 'SARS-CoV2 IgG levels'}, {'measure': 'T-cell response against SARS-CoV-2', 'timeFrame': '28 days after the second vaccination', 'description': 'SARS-CoV-2 specific T-cell subtype measured by interferon-γ release assays (IGRA)'}, {'measure': 'T-cell response against SARS-CoV-2', 'timeFrame': '22 weeks after the second vaccination', 'description': 'SARS-CoV-2 specific T-cell subtype measured by interferon-γ release assays (IGRA)'}, {'measure': 'SARS-CoV-2 incidence', 'timeFrame': '22 weeks after the second vaccination', 'description': 'Survey of the incidence of SARS-CoV-2 infections over the study period'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Chronic Kidney Disease 5D']}, 'descriptionModule': {'briefSummary': 'This is a prospective cohort study aimed to evaluate short- and mid-term immune response after SARS-CoV-2 vaccination using Gam-COVID-Vac (Sputnik V) vaccine in dialysis patients compared to the control group (medical staff).', 'detailedDescription': 'Background and aims: Patients receiving kidney replacement therapy with dialysis are at high risk of infection and death from COVID-19. There is a lack of evidence whether SARS-CoV-2 vaccination is effective in this immunocompromised group.\n\nStudy design: this is a prospective cohort study. Two cohorts will be included: dialysis patients and controls (medical staff), both vaccinated with Gam-COVID-Vac (Sputnik V) vaccine.\n\nBlood samples will be collected at 28 days and 22 weeks after after the second SARS-CoV-2 vaccine dose administration.\n\nThe primary outcome is the level of SARS-CoV-2 IgG antibodies on day 28 after the second vaccination as compared to controls.\n\nThe secondary outcomes are: 1) the level of SARS-CoV-2 IgG antibodies on week 22 after the second vaccination; 2) T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) 28 days and 22 weeks after the second vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects ≥ 18 years old who were vaccinated twice against SARS-CoV-2 using Gam-COVID-Vac (Sputnik V) vaccine.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 18 years or older\n* Previously vaccinated against SARS-CoV-2 with two administrations of Gam-COVID-Vac (Sputnik V) vaccine\n* Written informed consent.\n\nExclusion Criteria:\n\n* A history of previous COVID-19 disease\n* Active malignancy of any localization\n* Human Immunodeficiency Virus (HIV) infection\n* Maintenance treatment with immunosuppressive therapy.'}, 'identificationModule': {'nctId': 'NCT04805632', 'acronym': 'Sputnik-HD', 'briefTitle': 'Immune Response in Dialysis Patients Vaccinated Against COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Saint Petersburg State University, Russia'}, 'officialTitle': 'A Comparison of Short-term and Mid-term Immune Response in Dialysis Patients and Staff Vaccinated Against SARS-CoV-2 Using Gam-COVID-Vac (Sputnik V) Vaccine', 'orgStudyIdInfo': {'id': 'Sputnik_HD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dialysis', 'description': 'Patients on hemodialysis or peritoneal dialysis who received 2 administrations of Gam-COVID-Vac (Sputnik V) vaccine against SARS-CoV-2 infection'}, {'label': 'Healthy', 'description': 'Medical staff who received 2 administrations of Gam-COVID-Vac (Sputnik V) vaccine against SARS-CoV-2 infection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '190103', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Saint-Petersburg State University Hospital', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Petersburg State University, Russia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, MD', 'investigatorFullName': 'Ekaterina Parshina', 'investigatorAffiliation': 'Saint Petersburg State University, Russia'}}}}