Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT04760704
Status:
UNKNOWN
Last Update Posted:
2022-05-05
First Post:
2021-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Covid-19 Vaccine Response in Elderly Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum blood collection'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-28', 'studyFirstSubmitDate': '2021-02-17', 'studyFirstSubmitQcDate': '2021-02-17', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of specific cellular response after anti-SARS-CoV-2 BNT162b2 mRNA vaccine', 'timeFrame': 'At 3 months after the first vaccine administration', 'description': 'Number of gamma interferon-producing anti-S specific T cells detected 3 months after the first vaccine administration between elderly and control subjects'}], 'secondaryOutcomes': [{'measure': 'Specific CD4+ and CD8+ T cell response', 'timeFrame': 'At 3 months and at 9 months after vaccine administration', 'description': 'Comparison of number of anti-S specific CD4+ and CD8+ T cells detected at 3 and 9 months, between elderly and control subjects'}, {'measure': 'Total anti-S and neutralizing antibody levels', 'timeFrame': 'At 3 months and at 9 months after vaccine administration', 'description': 'Comparison of total anti-S and neutralizing antibody levels (to pseudo-viral particles and to live virus) at 3 and 9 months after vaccine administration between elderly and control subjects.'}, {'measure': 'Specific immune response according to presence/absence of pre-vaccine antibodies', 'timeFrame': 'At 3 months and at 9 months after vaccine administration', 'description': 'Comparison of anti-S specific T cells, anti-S total antibody and neutralising antibody levels at 3 and 9 months depending on the presence or absence of pre-vaccine antibodies compatible with previous infection in elderly subjects'}, {'measure': 'Specific immune response after COVID-19 vs after BNT162b2 mRNA vaccine', 'timeFrame': 'At 3 months after vaccine administration', 'description': 'Comparison of anti-S-specific total T-cell count, anti-S total antibody levels and neutralising antibody levels 3 months after COVID-19 infection (before any vaccination) and 3 months after vaccination (in subjects who had no COVID-19 before) in elderly subjects'}, {'measure': 'Specific immune response according to nutritional status', 'timeFrame': 'At 3 months and at 9 months after vaccine administration', 'description': 'Correlation between number of anti-S specific T cells, total anti-S antibody and neutralising antibody levels at 3 and 9 months and nutritional status of elderly subjects evaluated according to the Geriatric Nutritional Risk Index (GNRI) in elderly subjects.'}, {'measure': 'Correlation between number of T cells, total anti-S antibody and neutralising antibody at 3 and 9 months, and basal levels of proinflammatory cytokines (interleukin-6, TNF-alpha) in elderly subjects', 'timeFrame': 'At 3 months and at 9 months after vaccine administration'}, {'measure': 'Peripheral blood mononuclear cells and serum collection', 'timeFrame': 'before the first vaccine injection, 21 days after the first vaccine administration (recall), 28 days after recall, at 3, 6, 9, 12 and 24 months.', 'description': 'Sampling and conservation of mononuclear cells and serum before injection, at D21 (recall), 28 days after recall, at 3, 6, 9, 12 and 24 months, in elderly and control subjects.'}, {'measure': 'Correlation between number of T cell , total anti-S and neutralizing antibody levels at 3 and 6 months after diagnosis (neutralization tests will be performed on the variant of interest at the time of analysis)', 'timeFrame': 'at 3 and 6 months after diagnosis (neutralization tests will be performed on the variant of interest at the time of analysis)', 'description': 'The neutralizing antibody level at 3 and 6 months will be compared to the levels observed during the infection (serologies done systematically, serum available for retro analysis)'}, {'measure': 'Correlation between number of T-cell , total anti-S and neutralizing antibody levels before the booster and 3, 6 and 12 months after the booster (neutralization tests will be done on BA.1 and any variant of interest at the time of testing).', 'timeFrame': 'Before the booster and 3, 6 and 12 months after the booster'}, {'measure': 'Correlation between number of T-cell counts, total anti-S and neutralizing antibody levels within 24-48 hours of a positive PCR (neutralization tests will be done on the variant of interest at the time of testing).', 'timeFrame': 'within 24-48 hours of a positive PCR'}, {'measure': 'Saliva samples', 'timeFrame': 'at the time of a COVID-19 diagnosis and 3 months after diagnosis, before vaccination or 3, 6 and 12 months after booster.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'vaccination', 'immunosenescence'], 'conditions': ['Covid19 Vaccine']}, 'descriptionModule': {'briefSummary': 'The objective of this research is to assess the amplitude and quality of the vaccine response against SARS-CoV-2, defined here by its characteristics established at 3 months, and its persistence over time, defined here at 9 months, in subjects residing in medical establishment for dependent elderly persons, compared to immunocompetent subjects aged 40 to 65 years (control subjects for vaccination over the same period).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Elderly persons \\> 65 years of age residing in an institution for the elderly or in a long-term care unit for whom an anti-SARS-CoV-2 vaccination is indicated as recommended by French Health Authority (HAS)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTarget population.\n\n* Elderly persons \\> 65 years old residing in an institution for the elderly or in a long-term care unit for whom an anti-SARS-CoV-2 vaccination is indicated as recommended by French Health Authority (HAS)\n* Male or female resident in an institution for the elderly or in a long-term care unit\n* For whom consent has been obtained prior to any SARS-CoV-2 vaccination (or from the legal guardian/curator) by COMIRNATY®.\n* Having consented to participate in the study, and willing to comply with all study procedures and its duration\n* Socially insured patient\n\nControl population\n\n* Health and medico-social sector professionals aged between 40 and 65 years old for whom a COMIRNATY® anti-SARS-CoV-2 vaccination is indicated as recommended by the HAS.\n* Male or female between 40 and 65 years of age included\n* For whom consent has been obtained prior to any COMIRNATY® SARS-CoV-2 vaccination.\n* Having consented to participate in the study, and willing to comply with all study procedures and its duration\n* Socially insured subject\n\nExclusion Criteria, for both groups :\n\n* Progressive infectious pathology\n* Progressive neoplastic pathology (or remission of \\< 5 years)\n* Treatment with long-term corticosteroids or immunosuppressants\n* Refuse of consent to vaccination or study'}, 'identificationModule': {'nctId': 'NCT04760704', 'acronym': 'MONITOCOVAGING', 'briefTitle': 'Covid-19 Vaccine Response in Elderly Subjects', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Evaluation of the Immunogenicity of mRNA BNT162b2 (COMIRNATY®) Vaccine in Elderly Subjects by Monitoring the Specific Cellular and Humoral Response.', 'orgStudyIdInfo': {'id': '2021_02'}, 'secondaryIdInfos': [{'id': '2021-A00119-32', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental group', 'description': 'Persons aged 65 and over, residing in an institution for dependant elderly or in a long-term care unit', 'interventionNames': ['Biological: Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration']}, {'label': 'control group', 'description': 'Health and medico-social professionals between 40 and 65 years of age', 'interventionNames': ['Biological: Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration']}], 'interventions': [{'name': 'Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration', 'type': 'BIOLOGICAL', 'description': 'Specific T cells and specific antibodies assessment', 'armGroupLabels': ['Experimental group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHU lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Guillaume LEFEVRE, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}