Ignite Creation Date:
2025-12-24 @ 12:10 PM
Ignite Modification Date:
2025-12-28 @ 11:46 AM
Study NCT ID:
NCT05743361
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2023-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Security Efficacy COVID-19 Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 540}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-23', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-02-23', 'lastUpdatePostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Autoantibody Levels', 'timeFrame': 'Before vaccination and 1, 6 and 12 months after vaccination', 'description': 'ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti-TPO, anti-TG'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'Vaccine'], 'conditions': ['Autoimmune State', 'SARS-CoV-2 Infection']}, 'descriptionModule': {'briefSummary': 'Preliminary data support a possible molecular mimicry between SARS-CoV-2 and autologous components. This suggests the occurrence of autoimmunity during COVID-19. Consistently, autoimmunity may occur after SARS-CoV2 vaccination. The study aims to investigate the production of autoantibodies after vaccination in healtcare workers.', 'detailedDescription': 'Healtcare workers undergoing SARS-CoV-2 vaccination (with RNA-vaccines) will be included on a voluntary basis. Blood samples will be collected before and after vaccination (1 -3 - 6 - 12 months). All the vaccination side effects will be registered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthcare workers undergoing SARS-CoV-2 vaccination', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthcare workers undergoing SARS-CoV-2 vaccination\n\nExclusion Criteria:\n\n* Pregnancy\n* Full blown autoimmune diseases\n* Active vaccinations within 3 months before enrolment (excluding the influenza vaccine)\n* Previous vaccination severe side effects'}, 'identificationModule': {'nctId': 'NCT05743361', 'acronym': 'SECVAX', 'briefTitle': 'Security Efficacy COVID-19 Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Auxologico Italiano'}, 'officialTitle': 'Studio Sierologico in Volontari Vaccinati Contro COVID-19', 'orgStudyIdInfo': {'id': '20C121'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Autoantibodies', 'description': 'Detection of: ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti- TPO, anti-TG', 'interventionNames': ['Diagnostic Test: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'DIAGNOSTIC_TEST', 'description': 'Detection of ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti- TPO, anti-TG', 'armGroupLabels': ['Autoantibodies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20145', 'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Auxologico Italiano IRCCS', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Pierluigi Meroni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Auxologico Italiano IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}