Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-31 @ 11:23 AM
Study NCT ID:
NCT05409300
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2022-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Immunogenicity and Safety BBIBP-CorV Vaccine for COVID-19 in Adults in Guinea
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': 'C000722768', 'term': 'BIBP COVID-19 vaccine'}]}}, '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': '2022-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2022-03-28', 'studyFirstSubmitQcDate': '2022-06-07', 'lastUpdatePostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Measurement of specific B memory cells', 'timeFrame': 'Day 0, Month 2, Month 6, Month 12', 'description': 'Measurement of specific B memory cells (Elispot B)'}, {'measure': 'Measurement of specific T cell response', 'timeFrame': 'Day 0, Month 12', 'description': 'Measurement of specific T cell response (Cytof analysis)'}, {'measure': 'Identification of predictive determinants of vaccine response', 'timeFrame': 'Month 24', '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'}, {'measure': 'Quantitative measures', 'timeFrame': 'Day 0 until Month 24', 'description': 'Quantitative measures: Number of participants recruited, number of follow-up visits carried out, proportion of participants satisfied with the vaccine received'}], 'primaryOutcomes': [{'measure': 'Anti-SARS-CoV-2 Spike IgG level', 'timeFrame': '1 month after complete vaccination schema', 'description': 'Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level is measured using ELISA test'}], 'secondaryOutcomes': [{'measure': 'Anti-SARS-CoV-2 specific IgG level', 'timeFrame': 'Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24', 'description': 'Anti-SARS-CoV-2 specific IgG level is measured using ELISA test'}, {'measure': 'Anti-SARS-CoV-2 IgA and level', 'timeFrame': 'Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24', 'description': 'Anti-SARS-CoV-2 immunoglobulin A (IgA) level is measured using ELISA test'}, {'measure': 'Anti-SARS-CoV-2 IgM level', 'timeFrame': 'Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24', 'description': 'Anti-SARS-CoV-2 immunoglobulin M (IgM) level is measured using ELISA test'}, {'measure': 'Neutralizing antibody level for SARS-CoV-2', 'timeFrame': 'Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24', 'description': 'Neutralizing antibody levels specific for SARS-CoV-2 and its variants (conventional in vitro neutralization and pseudo-neutralization assays)'}, {'measure': 'Fluorospot tests (TH1, TH2, TH17, Cytotoxicity)', 'timeFrame': 'Day 0, Month 2, Month 6', 'description': 'Fluorospot tests (Type 1,2,17 helper T cell (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': 'Day 0, Month 1, Month 2, Month 6, Month 12', 'description': 'Mucosal SARS-CoV-2 specific antibody levels by measuring IgA, IgM and IgG in saliva using specific ELISAs'}, {'measure': 'Epitope profile', 'timeFrame': 'Day 0, 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 IgA and mucosal IgA and IgM functionality', 'timeFrame': 'Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24', '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': 'Month 1 until Month 24', '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': 'Day 0 until Month 24', 'description': 'Occurrence of confirmed COVID-19 cases during participant follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BBIBP-CorV', 'Elderly', 'SARS CoV 2 infected participants', 'Safety and immunogenicity'], 'conditions': ['COVID-19', 'Vaccine Adverse Reaction', 'Sars-CoV-2 Infection', 'Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'Phase II, non-randomized, open-label, comparative, single center national trial in Guinea, aimed to assess the humoral vaccine immune response induced by BBIBP-CorV vaccine in 200 adults aged between 18 and 45 years or 55 or older, one month after receiving the complete COVID-19 vaccination schedule.', 'detailedDescription': 'The main objective of this phase II trial is to evaluate the humoral immune response induced by the BBIBP-CorV vaccine in adults one month after complete vaccination regimen against SARS-CoV-2, comparing younger (up to 45 years old) and elderly (55+ years old) populations.\n\n200 participants will be included. 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\nParticipants will receive two doses of BBIBP-CorV at 28 days interval. Vaccines will be administered intramuscular (0.5mL per injection)\n\nHumoral vaccine immune responses, induced by BBIBP-CorV 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* Age between 46 and 54 years old\n* Positive SARS-CoV-2 antigenic test\n* Positive SARS-CoV-2 PCR results less than 48 hours old\n* History of infection by COVID-19 confirmed within 3 months prior to inclusion\n* Symptoms compatible with COVID-19: 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* Patient having received immunoglobulin or another blood product within 3 months prior to inclusion\n* Previously received at least one injection of a SARS-CoV-2 vaccine\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': 'NCT05409300', 'acronym': 'CovicompareG', 'briefTitle': 'Evaluation of the Immunogenicity and Safety BBIBP-CorV Vaccine for COVID-19 in Adults in Guinea', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'Phase II Trial Evaluating the Immunogenicity and Safety of BBIBP-CorV Vaccine in Adults in Guinea', 'orgStudyIdInfo': {'id': 'ANRS0144S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BBIBP-CorV', 'description': 'Intramuscular administration of two doses of vaccine at 28 days (+/- 2 days) interval (0.5 mL/dose)', 'interventionNames': ['Biological: BBIBP-CorV']}], 'interventions': [{'name': 'BBIBP-CorV', 'type': 'BIOLOGICAL', 'otherNames': ['Sinopharm'], 'description': 'Inactivated COVID19 vaccine, adjuvanted with aluminum hydroxide', 'armGroupLabels': ['BBIBP-CorV']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Conakry', 'country': 'Guinea', 'facility': 'Centre de recherche de Landreah', 'geoPoint': {'lat': 9.53795, 'lon': -13.67729}}, {'city': 'Conakry', 'country': 'Guinea', 'facility': 'Palais du Peuple', 'geoPoint': {'lat': 9.53795, 'lon': -13.67729}}], 'overallOfficials': [{'name': 'Odile Launay', 'role': 'STUDY_CHAIR', 'affiliation': 'Innovative clinical research network in vaccinology (I-REIVAC)'}, {'name': 'Abdoul Habib Beavogui', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre National de Formation et de Recherche en Santé Rurale (CNFRSR)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'CEPI', 'class': 'OTHER'}, {'name': 'Alliance for International Medical Action', 'class': 'OTHER'}, {'name': 'Centre National de Formation et de Recherche en Sante Rurale', 'class': 'OTHER_GOV'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'APHP', 'class': 'OTHER'}, {'name': 'Agence Nationale de Sécurité Sanitaire de la Guinée (ANSS Guinée)', 'class': 'UNKNOWN'}, {'name': 'Innovative clinical research network in vaccinology (IREIVAC)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}