Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT04954651
Status:
COMPLETED
Last Update Posted:
2022-06-06
First Post:
2021-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of the Immunization Levels Against Sars-Cov2 Virus in Subjects Who Have Received EU-approved COVID-19 Vaccines
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum from patients'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-02', 'studyFirstSubmitDate': '2021-07-06', 'studyFirstSubmitQcDate': '2021-07-06', 'lastUpdatePostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody titer against Sars-Cov2', 'timeFrame': '0-9 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sars-cov2', 'vaccine', 'age'], 'conditions': ['SARS-CoV2 Infection', 'Vaccine Reaction']}, 'referencesModule': {'references': [{'pmid': '35589363', 'type': 'DERIVED', 'citation': 'Parthymou A, Habeos EE, Habeos GI, Deligakis A, Livieratos E, Marangos M, Chartoumpekis DV. Factors associated with anti-SARS-CoV-2 antibody titres 3 months post-vaccination with the second dose of BNT162b2 vaccine: a longitudinal observational cohort study in western Greece. BMJ Open. 2022 May 19;12(5):e057084. doi: 10.1136/bmjopen-2021-057084.'}]}, 'descriptionModule': {'briefSummary': 'Patients who voluntarily visit vaccination centers in Greece against COVID-19 are recruited and their immunization levels against Sars-Cov2 are assesed by measurement of the levels of serum antibodies against Sars-cov-2 before vaccination and in time intervals up to 6-9 months post-vaccination (indicatively 0-1-3-6-9 months post-vaccination).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who voluntarily receive COVID-19 vaccines', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who voluntarily receive COVID-19 vaccination\n\nExclusion Criteria:\n\n* Patients who do not complete their vaccination\n* Patients who do not provide info on their health status'}, 'identificationModule': {'nctId': 'NCT04954651', 'briefTitle': 'Assessment of the Immunization Levels Against Sars-Cov2 Virus in Subjects Who Have Received EU-approved COVID-19 Vaccines', 'organization': {'class': 'OTHER', 'fullName': 'University of Patras'}, 'officialTitle': 'Assessment of the Immunization Levels Against Sars-Cov2 Virus in Subjects Who Have Received European Union (EU) -Approved COVID-19 Vaccines', 'orgStudyIdInfo': {'id': '99-25/2/2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VAC', 'description': 'Vaccinated subject against Sars-Cov2', 'interventionNames': ['Biological: Approved vaccines against Sars-Cov2']}], 'interventions': [{'name': 'Approved vaccines against Sars-Cov2', 'type': 'BIOLOGICAL', 'description': 'Subjects who voluntarily are vaccinated against Sars-Cov-2 with any of the approved vaccines by EU', 'armGroupLabels': ['VAC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26504', 'city': 'Pátrai', 'country': 'Greece', 'facility': 'University Hospital of Patras', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}], 'overallOfficials': [{'name': 'Ioannis Habeos, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Patras'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We plan to make the coded individual participant data available to other researchers upon reasonable request after the publication of the study in a journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Patras', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ioannis Habeos', 'investigatorAffiliation': 'University of Patras'}}}}