Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-25 @ 3:21 PM
Study NCT ID:
NCT05191368
Status:
UNKNOWN
Last Update Posted:
2022-01-28
First Post:
2022-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of Sars-cov-2 Vaccine in Patients With Rheumatic Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012216', 'term': 'Rheumatic Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-12', 'studyFirstSubmitDate': '2022-01-12', 'studyFirstSubmitQcDate': '2022-01-12', 'lastUpdatePostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sars-cov-2 neutralizing antibody', 'timeFrame': '2022.01.01', 'description': 'Inhibition rate of sars-cov-2 neutralizing antibody'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatic Disease']}, 'descriptionModule': {'briefSummary': "The purpose of this study was to preliminarily evaluate the immunogenicity of sars-cov-2 vaccine in patients with rheumatic diseases. The clinical information collection and blood sample testing of 100 healthy people and 200 patients with rheumatic diseases will be completed in Yunnan Traditional Chinese medicine hospital.\n\nResearch methods and procedures: clinical information collection and blood sample detection were carried out in healthy people and patients with rheumatic diseases, including systemic lupus erythematosus (SLE), antiphospholipid syndrome (APS), rheumatoid arthritis (RA), Sjogren's syndrome (SS), systemic sclerosis (SSC), idiopathic inflammatory myopathy (IIM), systemic vasculitis and spinal arthritis", 'detailedDescription': "Rheumatic diseases (RDS) are a large class of systemic diseases caused by genetic background, environment and physics, infection, metabolism, endocrine, immune response and other reasons, mainly involving joints and surrounding tissues. The diseases covered include systemic lupus erythematosus (SLE), antiphospholipid syndrome (APS), rheumatoid arthritis (RA) Sjogren's syndrome (SS), systemic sclerosis (SSC), idiopathic inflammatory myopathy (IIM), systemic vasculitis, spinal arthritis, etc. Patients with rheumatic diseases have an increased risk of infection due to autoimmune dysfunction and long-term use of hormones and immunosuppressants.\n\nThe incidence rate of coronary heart disease (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (severe acute respiratory syndrome coronavirus 2, SARS-CoV-2) in 2019 has resulted in high incidence and mortality worldwide. Although the epidemic prevention measures such as keeping distance and quarantine isolation have effectively improved and limited the epidemic scope and the number of infected people, the groups with low immunity are still the susceptible groups of sars-cov-2.\n\nVaccination is very important to suppress the epidemic and reduce the overall mortality. It can protect people from sars-cov-2 infection and the deterioration of covid-192, and has good safety. However, there are not enough reports on the safety and immunogenicity of sars-cov-2 vaccine in patients with rheumatic diseases. Studies have reported that the immunogenicity of sars-cov-2 vaccine is reduced in immunocompromised patients, including the use of immunosuppressive drugs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '① Meet the diagnostic criteria of rheumatic diseases in western medicine;\n\n② 18-70 years old, male or female;\n\n③ The patient voluntarily participated in this clinical study, has been informed of relevant matters, and signed the informed consent form', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet the diagnostic criteria of rheumatic diseases in western medicine;\n\n * 18-70 years old, male or female;\n\n * The patient voluntarily participated in this clinical study, has been informed of relevant matters, and signed the informed consent form\n\nExclusion Criteria:\n\nIt does not meet the diagnostic criteria of rheumatic diseases in western medicine'}, 'identificationModule': {'nctId': 'NCT05191368', 'briefTitle': 'Safety and Immunogenicity of Sars-cov-2 Vaccine in Patients With Rheumatic Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Yunnan University of Chinese Medicine'}, 'officialTitle': 'Yunnan University of Traditional Chinese Medicine', 'orgStudyIdInfo': {'id': 'Yunnan University of CM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal group', 'description': 'Healthy people who received two doses of COVID-19 vaccine', 'interventionNames': ['Other: No intervention']}, {'label': 'RA Patients injected with 2 doses of vaccine', 'description': 'RA Patients who received two doses of COVID-19 vaccine', 'interventionNames': ['Other: No intervention']}, {'label': 'Unvaccinated RA patients', 'description': 'RA Patients who received zero doses of COVID-19 vaccine', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Normal group', 'RA Patients injected with 2 doses of vaccine', 'Unvaccinated RA patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '650500', 'city': 'Kunming', 'state': 'Kunming', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ting Zhao, Resident', 'role': 'CONTACT', 'email': '420922691@qq.com', 'phone': '18468146375'}], 'facility': 'Yunnan University of traditional Chinese Medicine', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}], 'centralContacts': [{'name': 'Ting Zhao', 'role': 'CONTACT', 'email': '420922691@qq.com', 'phone': '18468146375'}, {'name': 'Fanying Meng', 'role': 'CONTACT', 'email': '1026792964@qq.com', 'phone': '18211951157'}], 'overallOfficials': [{'name': 'Fanying Meng', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yunnan University of Chinese Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yunnan University of Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Ting Zhao', 'investigatorAffiliation': 'Yunnan University of Chinese Medicine'}}}}