Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-03 @ 10:54 PM
Study NCT ID:
NCT06567457
Status:
WITHDRAWN
Last Update Posted:
2024-08-22
First Post:
2023-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety Study of Monovalent Omicron XBB.1.5 Vaccine as a Booster in Adults
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': 'C000721887', 'term': 'SCB-2019 COVID-19 vaccine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'varients of COVID-19 has changed', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2023-08-23', 'studyFirstSubmitQcDate': '2024-08-20', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GMT ratio', 'timeFrame': 'Day 15', 'description': 'Demonstrate that SCB-2023B vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5'}, {'measure': 'Assess the reactogenicity of SCB-2023B vaccine compared to SCB-2019 vaccine', 'timeFrame': 'Day 7', 'description': 'Proportion of participants with local and systemic AEs'}, {'measure': 'Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine', 'timeFrame': 'Day 29', 'description': 'Proportion of participants with unsolicited AEs'}, {'measure': 'Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine', 'timeFrame': 'Up to 1 year post-vaccination', 'description': 'Proportion of participants with SAE, AEs leading to early termination from study, MAAEs, and AESIs'}], 'secondaryOutcomes': [{'measure': 'Non-inferiority of the Omicron XBB.1.5 immune response elicited by SCB-2023B vaccine versus SARS-CoV-2 Delta titers in a subset of naïve participants of the CLO-SCB-2019-003 clinical study (virus neutralization assay)', 'timeFrame': 'Day 15', 'description': 'GMT ratio'}, {'measure': 'GMTs', 'timeFrame': 'Day 1, 15, 180', 'description': 'Geometric mean titers elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron XBB.1.5'}, {'measure': 'GMFRs', 'timeFrame': 'Day 1, 15, 180', 'description': 'Geometric mean fold rise elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron XBB.1.5'}, {'measure': 'SCRs', 'timeFrame': 'Day 1, 15, 180', 'description': 'Proportion of subjects with seroconversion by virus neutralization assay against Omicron XBB1.5'}, {'measure': 'Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron XBB1.5', 'timeFrame': 'Day 1, 15, 180', 'description': 'Proportion of participants with antibody titer ≥ LLoQ'}, {'measure': 'GMTs', 'timeFrame': 'Day 1, 15', 'description': 'Geometric mean titers elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against new emergent SARS-CoV-2 strains'}, {'measure': 'GMFRs', 'timeFrame': 'Day 1, 15', 'description': 'Geometric mean fold rise elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against new emergent SARS-CoV-2 strains'}, {'measure': 'SCRs', 'timeFrame': 'Day 1, 15', 'description': 'Proportion of subjects with seroconversion by virus neutralization assay against new emergent SARS-CoV-2 strains'}, {'measure': 'Proportion of subjects with antibody titer >=LLOQ', 'timeFrame': 'Day 1, 15', 'description': 'Proportion of participants with antibody titer ≥ LLoQ by virus neutralization assay against new emergent SARS-CoV-2 strains'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the immunogenicity and safety of SCB-2023B monovalent Omicron XBB.1.5 vaccine compared to the prototype SCB-2019 vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.', 'detailedDescription': 'The purpose of this study is to assess the immunogenicity and safety of SCB-2023B monovalent Omicron XBB.1.5 vaccine compared to the prototype SCB-2019 vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female ≥18 years of age.\n* Individuals willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures.\n* Individuals willing and able to give an informed consent, prior to screening.\n* Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition.\n* Individuals who received three doses of inactivated COVID-19 vaccine\n\nExclusion Criteria:\n\n* Body temperature \\>37.8°C (axillary), or any acute illness at baseline.\n* Confirmed SARS-CoV-2 infectionor with known history of COVID-19.\n* Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1 (except for inactivated COVID-19 vaccine).\n* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.\n* Any progressive unstable or uncontrolled clinical conditions.\n* Individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or during the study period.\n* History of severe adverse reaction associated with a vaccine or severe allergic reaction.\n* History of malignancy within 1 year before screening.\n* Individuals who have received any other investigational product.\n* Individuals who have received any other licensed vaccines within 14 days prior to enrollment.\n* Treatment with Rituximab or any other anti-CD20 monoclonal antibodies.\n* Known bleeding disorder that would, in the opinion of the investigator, contraindicate i.m. injection.\n* Administration of intravenous immunoglobulins and/or any blood products.\n* Any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant.'}, 'identificationModule': {'nctId': 'NCT06567457', 'briefTitle': 'Immunogenicity and Safety Study of Monovalent Omicron XBB.1.5 Vaccine as a Booster in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clover Biopharmaceuticals, Ltd'}, 'officialTitle': 'Phase 3, Multi-center, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Monovalent Omicron XBB.1.5 Vaccine Administered as a Booster Dose to Adults Who Previously Received COVID-19 Vaccine', 'orgStudyIdInfo': {'id': 'CLO-SCB-2023B-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SCB-2023B', 'description': 'Participants will receive one booster dose with SCB-2023B vaccine on Day 1', 'interventionNames': ['Biological: SCB-2023B vaccine, a monovalent Omicron XBB.1.5 recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SCB-2019', 'description': 'Participants will receive one booster dose with SCB-2019 vaccine on Day 1', 'interventionNames': ['Biological: SCB-2019 vaccine, a monovalent wu-hu1 SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19']}], 'interventions': [{'name': 'SCB-2023B vaccine, a monovalent Omicron XBB.1.5 recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19', 'type': 'BIOLOGICAL', 'description': 'intramuscular injection', 'armGroupLabels': ['SCB-2023B']}, {'name': 'SCB-2019 vaccine, a monovalent wu-hu1 SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19', 'type': 'BIOLOGICAL', 'description': 'intramuscular injection', 'armGroupLabels': ['SCB-2019']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clover Biopharmaceuticals AUS Pty', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}