Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT05047718
Status:
COMPLETED
Last Update Posted:
2024-12-11
First Post:
2021-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Factors Influencing the COVID-19 Vaccine Immune Response According to Age and Presence or Not of a Past History of COVID-19
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090982', 'term': 'BNT162 Vaccine'}], 'ancestors': [{'id': 'D000087503', 'term': 'mRNA Vaccines'}, {'id': 'D000087504', 'term': 'Nucleic Acid-Based Vaccines'}, {'id': 'D014614', 'term': 'Vaccines, Synthetic'}, {'id': 'D011994', 'term': 'Recombinant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000086663', 'term': 'COVID-19 Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2021-09-14', 'studyFirstSubmitQcDate': '2021-09-14', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-S neutralizing antibody titer', 'timeFrame': 'Days : 15, 90, 180 after each dose of vaccine', 'description': 'The neutralizing antibody titer against protein S from the majority variants at the time of sampling and vaccine S will be evaluated in viral neutralization and pseudoneutralization'}], 'secondaryOutcomes': [{'measure': 'Kinetic of Anti-S antibody titer', 'timeFrame': 'Days : 15, 90, 180 after each dose of vaccine', 'description': 'The antibody titer against protein S will be evaluated by ELISA'}, {'measure': 'Kinetic of Anti-N antibody titer', 'timeFrame': 'Days : 15, 90, 180 after each dose of vaccine', 'description': 'The antibody titer against protein N will be evaluated by ELISA'}, {'measure': 'Kinetic of Anti-SARS-CoV-2 immunoglobulin A (IgA) titers in saliva', 'timeFrame': 'Days : 15, 90, 180 after each dose of vaccine'}, {'measure': 'Kinetic of SARS-CoV-2 quantiferon value', 'timeFrame': 'Days : 15, 90, 180 after each dose of vaccine'}, {'measure': 'CD4 and CD8 lymphocyte polarization specific to the vaccine S protein', 'timeFrame': 'Days : 15 (group Naive and convalescent), 180 (group Boost only) after last dose of vaccine', 'description': 'Evaluate by TruCulture (Myriad) methode'}, {'measure': 'Anti-S neutralizing antibody titer', 'timeFrame': 'Days : 15, 90, 180 after each dose of vaccine', 'description': 'The neutralizing antibody titer against protein S from the majority variants at the time of sampling and vaccine S will be evaluated in viral neutralization and pseudoneutralization'}, {'measure': 'Kinetic of serum cytokine levels', 'timeFrame': 'At 24 and 72 hours after each dose of vaccine'}, {'measure': 'Kinetic of C-reactive protein', 'timeFrame': 'At 24 and 72 hours after each dose of vaccine'}, {'measure': 'Kinetic of vaccine-induced genes signatures', 'timeFrame': 'At 24 and 72 hours after each dose of vaccine', 'description': 'Expression kinetics in foldchange (transcriptomics) of vaccine-induced gene signatures in peripheral blood mononuclear cells'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunogenicity', 'reactogenicity', 'mRNA COVID-19 vaccine', 'COVID-19 natural immunity', 'age'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'Age is the main risk factor associated with the severity of COVID-19. From the beginning of the vaccination campaign, elderly subjects are part of the priority population. However, immunosenescence appears to play a role in the natural post-COVID-19 immunity of convalescent elderly subjects and also in the post-vaccination response. However, vaccination recommendations for both naïve (2 doses of vaccine) and convalescent subjects (1 dose of vaccine) do not differ according to age. To date, there is little data to suggest that the response to the vaccine in naïve or convalescent subjects may vary according to age in terms of qualitative and quantitative response and duration.', 'detailedDescription': 'In addition, the reactogenicity following the vaccine, remains important with COVID-19 vaccines, whether using an Messenger RiboNucleic Acid (mRNA) technique or an adenovirus vector technique. A better understanding of the parameters of early inflammatory response explaining this reactogenicity would allow to optimize the formulation of future vaccines. There are still several unknowns concerning the post-vaccination immune response (immunogenicity and reactogenicity) in older subjects,depending on their history of COVID-19 and the type of vaccine administered. A better understanding of this immune response is necessary in order to propose the best vaccine strategies and regimens in this high-risk COVID-19 population.\n\nThus, in partnership with Sanofi Pasteur and Bioaster, the Group On Mucosal Immunity And Pathogens (GIMAP) and Circulating Immune Complexes (CIC) vaccinology team proposes to conduct a study comparing the humoral, cellular, mucosal and reactogenic post-vaccination immune response in subjects with a history of COVID-19 \\>3 months ago (convalescent, 1 dose of vaccine) versus subjects with no history of COVID-19 (naive, 1 or 2 doses of vaccine depending on the type of vaccine used) according to age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For the group with a past history of COVID-19 (convalescents)= subject within ≥ 3 months after infection\n* For the NO past history of COVID-19 (naives), subject with no known history of COVID-19\n* Patient affiliated or entitled to a social security plan\n* Patients who have received informed information about the study and who have co-signed a consent to participate in the study with the investigator\n\nExclusion Criteria:\n\n* Immunocompromised or under immunosuppressive treatment\n* Subject with a history of COVID hospitalized in intensive care\n* Subject allergic to one of the components of the vaccines used in the study\n* subject vaccinated for COVID-19\n* Subject with persistent symptoms of COVID-19 (long COVID)\n* Subjects with unstable chronic pathology\n* Persons deprived of liberty, hospitalized without consent\n* Pregnant or breastfeeding woman'}, 'identificationModule': {'nctId': 'NCT05047718', 'acronym': 'COVIMMUNAGE', 'briefTitle': 'Factors Influencing the COVID-19 Vaccine Immune Response According to Age and Presence or Not of a Past History of COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Factors Influencing the COVID-19 Vaccine Immune Response (Reactogenicity and Immunogenicity) According to Age and Presence or Not of a Past History of COVID-19', 'orgStudyIdInfo': {'id': '21CH134'}, 'secondaryIdInfos': [{'id': '2021-003547-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'convalescent participants PFIZER', 'description': 'Participants with prior history of COVID-19 in ≥3 months, virologically confirmed and vaccinated by anti-covid19 Pfizer vaccine', 'interventionNames': ['Biological: COVID-19 vaccine Pfizer (2 doses)']}, {'type': 'EXPERIMENTAL', 'label': 'Naive participants PFIZER', 'description': 'Participant without past history of COVID-19 and vaccinated by anti-covid19 Pfizer vaccine', 'interventionNames': ['Biological: COVID-19 vaccine Pfizer (3 doses)']}, {'type': 'EXPERIMENTAL', 'label': 'convalescent participants MODERNA', 'description': 'Participants with prior history of COVID-19 in ≥3 months, virologically confirmed and vaccinated by anti-covid19 Moderna vaccine', 'interventionNames': ['Biological: COVID-19 mRNA Vaccine Moderna (2 doses)']}, {'type': 'EXPERIMENTAL', 'label': 'Naive participants MODERNA', 'description': 'Participant without past history of COVID-19 and vaccinated by anti-covid19 Moderna vaccine', 'interventionNames': ['Biological: COVID-19 mRNA Vaccine Moderna (3 doses)']}, {'type': 'EXPERIMENTAL', 'label': 'Boost only', 'description': 'Participant without past history of COVID-19 and vaccinated by anti-covid19 mRNA vaccine.', 'interventionNames': ['Biological: COVID-19 mRNA Vaccine Moderna (1 dose)']}], 'interventions': [{'name': 'COVID-19 vaccine Pfizer (3 doses)', 'type': 'BIOLOGICAL', 'description': 'A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring', 'armGroupLabels': ['Naive participants PFIZER']}, {'name': 'COVID-19 vaccine Pfizer (2 doses)', 'type': 'BIOLOGICAL', 'description': 'A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring', 'armGroupLabels': ['convalescent participants PFIZER']}, {'name': 'COVID-19 mRNA Vaccine Moderna (3 doses)', 'type': 'BIOLOGICAL', 'description': 'A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring', 'armGroupLabels': ['Naive participants MODERNA']}, {'name': 'COVID-19 mRNA Vaccine Moderna (2 doses)', 'type': 'BIOLOGICAL', 'description': 'A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring', 'armGroupLabels': ['convalescent participants MODERNA']}, {'name': 'COVID-19 mRNA Vaccine Moderna (1 dose)', 'type': 'BIOLOGICAL', 'description': 'A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring', 'armGroupLabels': ['Boost only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'HCL - Hôpital Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Elisabeth BOTELHO-NEVERS, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de St Etienne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, {'name': 'Bioster, a.s.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}