Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-01-03 @ 10:21 PM
Study NCT ID:
NCT05409261
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2022-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Immunogenicity and Safety of Ad26.COV2.S's COVID-19 Vaccine
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': 'D000090984', 'term': 'Ad26COVS1'}], 'ancestors': [{'id': 'D000086663', 'term': 'COVID-19 Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2022-04-01', 'studyFirstSubmitQcDate': '2022-06-07', 'lastUpdatePostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Measurement of specific B memory cells and T cell response', 'timeFrame': 'B memory cells: Day 0 and then 2,6, and 12 months after inclusion., T cell : Inclusion (D0) and then at 12 months after inclusion', 'description': 'Measurement of specific B memory cells (Elispot B) and T cell response (Cytof analysis)'}, {'measure': 'Identification of predictive determinants of vaccine response', 'timeFrame': 'Day 0 until 24 months', 'description': 'Identification of pre-existing immunity against other coronaviruses or respiratory pathogens, immunosenescence profile, transcriptomic, metabolomic and proteomic analysis, cytokine profile (IFNa), immune cell phenotype'}], 'primaryOutcomes': [{'measure': 'Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level', 'timeFrame': 'One month after complete vaccination schema', 'description': 'Anti-SARS-CoV-2 Spike IgG level is measured using ELISA test'}], 'secondaryOutcomes': [{'measure': 'Anti-SARS-CoV-2 Spike IgG level', 'timeFrame': 'At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion', 'description': 'Anti-SARS-CoV-2 Spike IgG level is measured using ELISA test'}, {'measure': 'Anti-SARS-CoV-2 immunoglobulin M (IgM) level', 'timeFrame': 'At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion', 'description': 'Anti-SARS-CoV-2 IgM level is measured using ELISA test'}, {'measure': 'Neutralizing antibody level for SARS-CoV-2', 'timeFrame': 'Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion', 'description': 'Neutralizing antibody levels specific for SARS-CoV-2 and its variants (conventional in vitro neutralization and pseudo-neutralization assays)'}, {'measure': 'Fluorospot tests (type 1,2, and 17 helper T cell (TH1, TH2, TH17), Cytotoxicity)', 'timeFrame': 'Inclusion (Day 0) and then 2 and 6 months after inclusion', 'description': 'Fluorospot tests (TH1, TH2, TH17, Cytotoxicity) Phenotyping of antigen-specific T cells by mass cytometry at Day 0 and Month 6 selected from the results of the Fluorospot test.'}, {'measure': 'Mucosal SARS-CoV-2 specific antibody levels', 'timeFrame': 'Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion', 'description': 'Mucosal SARS-CoV-2 specific antibody levels by measuring IgA, IgM and IgG in saliva using specific ELISAs'}, {'measure': 'Determination of Epitope profile', 'timeFrame': 'Day 0 and Month 2', 'description': 'Determination of epitope profile'}, {'measure': 'B cell response to vaccine', 'timeFrame': 'Day 0, Month 2, Month 6', 'description': 'Determination of repertoire of B cells (stereotype clonotype)'}, {'measure': 'Measurement of ultrasensitive immunoglobulin A (IgA) and mucosal IgA and IgM functionality', 'timeFrame': 'Day 0 and then 1, 2, 6, 12, and 24 months after inclusion', 'description': 'Measurement of ultrasensitive IgA in saliva by Photoring assay Measurement of mucosal IgA and IgM functionality by SARS-CoV-2 mucosal IgA- and IgM-specific antibody-dependent cell-mediated cytotoxicity (ADCC) test'}, {'measure': 'Rate of adverse events', 'timeFrame': 'Between month 1 and month 24 after inclusion', 'description': 'Rate of adverse events of any grade attributable to the vaccine or vaccination occurring between Month 1 and Month 24'}, {'measure': 'SARS-CoV-2 infection', 'timeFrame': 'Date of inclusion until 24 months', 'description': 'Occurrence of confirmed COVID-19 cases during participant follow-up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ad26.COV2.S'], 'conditions': ['COVID-19', 'Vaccine Reaction', 'SARS CoV 2 Infection', 'Vaccine Adverse Reaction']}, 'descriptionModule': {'briefSummary': 'Phase II, non-randomized, open-label, comparative, national, multicenter trial in Mali, aimed to assess the humoral vaccine immune response induced by Ad26.COV2.S vaccine in 200 adults one month after receiving the complete vaccination schedule of SARS-CoV-2 vaccine.', 'detailedDescription': 'The main objective of this phase II trial is to evaluate the humoral immune response induced by the Ad26.COV2.S vaccine in adults one month after complete vaccination regimen against SARS-CoV-2, compared younger (up to 45 years old) and elderly (55+ years old) populations.\n\n200 participants will be included, 200 participants for each vacine. The age categories are 18 - 45 years, 55 - 64 years and 65+ years. The number of participants per age group will be distributed as follows 1:1:0,5. There will be no comparison between population on different vaccines.\n\nAd26.COV2 vaccine (200 participants) 18-45 years old, 80 participants 55-64 years old, 80 participants 65 years old or older, 40 participants\n\nParticipants in Ad26.COV2 arm receive intramuscularly as a single dose of 0.5mL.\n\nHumoral vaccine immune responses, induced by Ad26.COV2.S vaccine, will be measured by ELISA at D0, M1, M2, M6, M12 and M24.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18 and 45 years old or 55 years and older\n* Be eligible to receive one of the study vaccines as part of the trial\n* Understand and agree to comply with study procedures (visits, telephone calls)\n* Agree not to participate in any other vaccine study during the time of the study\n* Give written informed consent prior to any examination performed as part of the trial\n\nExclusion Criteria:\n\n* Positive SARS-CoV-2 antigenic test\n* Positive SARS-CoV-2 polymerase chain reaction (PCR) results less than 48 hours old\n* History of infection by SARS-CoV-2 confirmed by antigenic test or PCR within 3 months prior to inclusion\n* Symptoms compatible with infection to SARS-CoV-2: sick or febrile participants (body temperature ≥ 38.0°C)\n* Pregnant or breastfeeding woman\n* Known chronic disease impacting the participant's immune response (uncured cancer, human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection)\n* Anti-coagulant treatment\n* Immunosuppressive treatment\n* Contraindication to the proposed vaccine (according to RCP)\n* Previously received at least one injection of a SARS-CoV-2 vaccine\n* Patient having received immunoglobulin or another blood product within 3 months prior to inclusion\n* A history of serious adverse vaccine reactions (anaphylaxis and associated symptoms such as rash, breathing difficulties, laryngeal edema, or a history of allergic reaction that may be exacerbated by a component of the SARS-CoV-2 vaccine)\n* Any condition that, in the opinion of the investigator, may adversely affect the well-being of the participant and interfere with the purpose of the study"}, 'identificationModule': {'nctId': 'NCT05409261', 'acronym': 'CoviComMali', 'briefTitle': "Evaluation of the Immunogenicity and Safety of Ad26.COV2.S's COVID-19 Vaccine", 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'Phase II Trial Evaluating the Immunogenicity and Safety of Ad26.COV2.S Vaccine in Adult Participants in Mali', 'orgStudyIdInfo': {'id': 'ANRS0142S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ad26.COV2.S', 'description': 'Single dose (0.5mL) of SARS-CoV-2 vaccine Ad26.COV2.S.', 'interventionNames': ['Biological: Ad26.COV2.S']}], 'interventions': [{'name': 'Ad26.COV2.S', 'type': 'BIOLOGICAL', 'otherNames': ['Janssen', 'Johnson&Johnson'], 'description': 'Recombinant vaccine, contains Adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein', 'armGroupLabels': ['Ad26.COV2.S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '251', 'city': 'Bamako', 'country': 'Mali', 'facility': 'CVD-MALI', 'geoPoint': {'lat': 12.60915, 'lon': -7.97522}}], 'overallOfficials': [{'name': 'Odile Launay', 'role': 'STUDY_CHAIR', 'affiliation': 'Innovative clinical research network in vaccinology (I-REIVAC)'}, {'name': 'Samba Sow', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Vaccine Development-Mali (CVD-Mali)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'CEPI', 'class': 'OTHER'}, {'name': 'Innovative clinical research network in vaccinology (IREIVAC)', 'class': 'UNKNOWN'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'APHP', 'class': 'OTHER'}, {'name': 'Center for Vaccine Development - Mali', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}