Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 4:18 PM
Study NCT ID:
NCT05102669
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2021-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spike-specific Cellular Immune Response After COVID-19 Vaccination
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': 'NONE_RETAINED', 'description': 'whole blood samples and serum samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2021-10-28', 'studyFirstSubmitQcDate': '2021-10-28', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurement of cellular response', 'timeFrame': '7 months', 'description': 'evaluation of the increase of Spike-specific B and T cells percentage after COVID-19 vaccination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID19', 'Vaccination', 'Immune Response']}, 'descriptionModule': {'briefSummary': 'Aim of this study is to evaluate whether COVID-19 vaccination induces a persistent cellular immune response.\n\nTo this aim, blood samples are taken from vaccinated individuals and not immunized subjects as a control group.\n\nCells isolated from blood samples are tested in vitro to assess the percentage of spike-specific T and B lymphocytes 1 and 7 months after a second dose of Comirnaty vaccine.', 'detailedDescription': 'After providing written informed consent, 28 vaccinated and 25 non vaccinated subjects were included in the study. All subjects were enrolled among healthcare workers in the Research Centre of IRCCS San Raffaele Roma in Rome.\n\nAll the subjects declared that they never tested positive for COVID19. Blood and serum samples were drowned twice from vaccinated subjects: 1 and 7 months after a second dose of vaccine to evaluate T and B response to vaccine; blood was drowned once in not vaccinated subjects.\n\nCells were collected form peripheral blood samples, while anti-S1 IgG titre was assessed in serum.\n\nFlow-cytometry was used to assess the percentage of circulating spike-specific T and B lymphocytes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'IRCCS San Raffaele Roma health care workers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* vaccinated and non vaccinated subjects\n* subjects that never tested positive for COVID19\n\nExclusion Criteria:\n\n* subjects that tested positive for COVID-19'}, 'identificationModule': {'nctId': 'NCT05102669', 'acronym': 'RIS-COV', 'briefTitle': 'Spike-specific Cellular Immune Response After COVID-19 Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele Roma'}, 'officialTitle': 'Spike-specific Cellular Immune Response After COVID-19 Vaccination', 'orgStudyIdInfo': {'id': 'RP 20/09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'vaccinated', 'description': 'COVID19 vaccinated subjects', 'interventionNames': ['Other: analysis of immunological response', 'Diagnostic Test: analysis of serum antibodies']}, {'label': 'non vaccinated', 'description': 'COVID19 non vaccinated subjects', 'interventionNames': ['Other: analysis of immunological response']}], 'interventions': [{'name': 'analysis of immunological response', 'type': 'OTHER', 'description': 'collection and analysis of SARS-CoV2 Spike specific blood cells', 'armGroupLabels': ['non vaccinated', 'vaccinated']}, {'name': 'analysis of serum antibodies', 'type': 'DIAGNOSTIC_TEST', 'description': 'analysis of anti-SARS-CoV2 Spike specific antibodies', 'armGroupLabels': ['vaccinated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00163', 'city': 'Roma', 'country': 'Italy', 'facility': 'IRCCS San Raffaele Roma', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Laura Vitiello, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS San Raffaele Roma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele Roma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}