Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT04961502
Status:
UNKNOWN
Last Update Posted:
2021-07-14
First Post:
2021-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Humoral and Cellular Responses to Vaccination Against Coronavirus Disease 2019 (COVID-19) in the Very Elderly Living in Geriatric Institutions
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3 blood samples taken to compare the immunization response of the elderly with that of younger adults (priority caregivers)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-12', 'studyFirstSubmitDate': '2021-06-04', 'studyFirstSubmitQcDate': '2021-07-12', 'lastUpdatePostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment the percentage of patients who developed anti-RBD antibodies after vaccination by blood sample', 'timeFrame': '50 days'}], 'primaryOutcomes': [{'measure': 'Measure plasma concentration of anti-RBD IgG antibodies in elderly using SARS-CoV-2 IgG II Quant assay technique (Abbott)', 'timeFrame': '50 days'}], 'secondaryOutcomes': [{'measure': 'Measure plasma concentration of anti-RBD IgG antibodies in younger adults using SARS-CoV-2 IgG II Quant assay technique (Abbott)', 'timeFrame': '50 days'}, {'measure': 'Assess the percentage of patients with previous COVID-19 infection prior to vaccination', 'timeFrame': 'At inclusion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mRNA BNT162b2 vaccine', 'Coronavirus desease 2019 (Covid-19)', 'anti-RBD IgG', 'vaccine antibodies', 'blood sample'], 'conditions': ['Elderly People Institutionalized in Long-term Care Services']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to describe the humoral and cellular response to BNT162b2 vaccination in people over age 75 institutionalized in the long-term care units of the Paris Public Hospitals (APHP)', 'detailedDescription': 'This is an interventional study with minimal risk and constraints, multicenter with biological collection. Two populations are studied: patients and members of care staff.\n\nThe following data will be collected:\n\n* For patients and staff: age, gender, existence of Coronavirus Disease 2019 (COVID-19) infection and whether or not it is symptomatic and date of first positive RT-PCR test, medical history\n* For patients: nutritional status (loss of appetite, weight loss, body mass index, albuminemia)\n\nVaccination antibodies are measured using 3 blood sample:\n\nThe first carried out before the anti-Coronavirus Disease 2019 (COVID-19) vaccination; the second on D21 (shortly before the vaccination booster injection) and the third on D50-54.\n\nIn addition, during the first sample, assays will be carried out informing us of your nutritional and inflammatory status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for patients:\n\n* Person aged 75 and over,\n* Hospitalized in a long-term care unit participating in the study,\n* Having agreed to be vaccinated with the BNT162b2 vaccine as part of the phase 1 vaccination campaign defined by the health authorities,\n* Not having received any other vaccination or corticosteroid treatment during the 3 weeks preceding the start of the study,\n* Having given their written consent to participate in the study, or having not expressed their opposition to participating and whose legal guardian has given their consent.\n\nInclusion Criteria for younger adults (priority care staff):\n\n* Staff who have agreed to be vaccinated with the BNT162b2 vaccine as part of the phase 1 vaccination campaign defined by the health authorities,\n* Not having received any other vaccination or corticosteroid treatment during the 3 weeks preceding the start of the study,\n* Having given their written consent to participate in the study.'}, 'identificationModule': {'nctId': 'NCT04961502', 'acronym': 'COGEVAX-BIO', 'briefTitle': 'Humoral and Cellular Responses to Vaccination Against Coronavirus Disease 2019 (COVID-19) in the Very Elderly Living in Geriatric Institutions', 'organization': {'class': 'OTHER', 'fullName': "Gérond'if"}, 'officialTitle': 'Humoral and Cellular Responses to Vaccination Against Coronavirus Disease 2019 (COVID-19) in the Very Elderly Living in Geriatric Institutions', 'orgStudyIdInfo': {'id': '2021-A00051-40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Elderly person', 'description': 'Three blood sample: the first carried out before the anti-COVID-19 vaccination; the second shortly before the vaccination booster injection and the third approximately two months after the first vaccine injection', 'interventionNames': ['Biological: Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Younger adults (priority caregivers)', 'description': 'Three blood sample: the first carried out before the anti-COVID-19 vaccination; the second shortly before the vaccination booster injection and the third approximately two months after the first vaccine injection', 'interventionNames': ['Biological: Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly']}], 'interventions': [{'name': 'Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly', 'type': 'BIOLOGICAL', 'description': '3 blood samples taken to compare the immunization response of the elderly with that of younger adults (priority caregivers): the first carried out before the anti-Coronavirus Disease 2019 (COVID-19) vaccination; the second shortly before the vaccination booster injection and the third approximately two months after the first vaccine injection', 'armGroupLabels': ['Elderly person', 'Younger adults (priority caregivers)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94200', 'city': 'Ivry-sur-Seine', 'state': 'IIe-de-France', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Geriatric Department, Charles Foix hospital', 'geoPoint': {'lat': 48.81568, 'lon': 2.38487}}], 'centralContacts': [{'name': 'Isabelle Dufour', 'role': 'CONTACT', 'email': 'isabelle.dufour@gerondif.org', 'phone': '+33 (0)185781010'}, {'name': 'Adrien Besseivhe', 'role': 'CONTACT', 'email': 'adrien.besseiche@gerondif.org', 'phone': '+33 (0)185781010'}], 'overallOfficials': [{'name': 'Joël Belmin, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Geriatric Department, Charles Foix hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gérond'if", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}