Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-04-07 @ 4:15 PM
Study NCT ID:
NCT06984094
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2025-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First-in-human Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 192}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2025-05-14', 'studyFirstSubmitQcDate': '2025-05-14', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.', 'timeFrame': 'Within 7 days after vaccination', 'description': 'Proportion of participants with local and systemic solicited AEs'}, {'measure': 'To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.', 'timeFrame': 'Within 28 days after vaccination', 'description': 'Proportion of participants with unsolicited AEs'}, {'measure': 'To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.', 'timeFrame': 'Throughout the study period, from enrollment to 6 months follow up', 'description': 'Proportion of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study'}, {'measure': 'To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.', 'timeFrame': 'Screening and day 8', 'description': 'Mean change and shift from baseline in hematology, biochemistry and coagulation parameters; by safety set.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Respiratory Syncytial Virus vaccination', 'Human Matapneumovirus vaccination', 'Parainfluenza vaccination', 'healthy volunteers'], 'conditions': ['Respiratory Syncytial Virus Vaccination', 'Human Metapneumovirus Vaccination', 'Parainfluenza Vaccination']}, 'descriptionModule': {'briefSummary': 'This phase 1 study will evaluate the safety, reactogenicity, and immunogenicity of 3 different dose levels of SCB-1022 and SCB-1033 in healthy adults aged 60-85 years.', 'detailedDescription': 'The study will descriptively evaluate three dose levels of SCB-1022 and SCB-1033. The sample size for this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1 study. The study will be overseen by a safety monitoring committee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female participants 60 to 85 years of age at the screening visit.\n* Individuals willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.\n* Individuals willing and able to give an informed consent, prior to screening.\n* Healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator; participants with pre-existing stable medical conditions can be included.\n\nPlease refer to Protocol for full list of Inclusion and Exclusion criteria.\n\nExclusion Criteria:\n\n* Pregnancy or potential to become pregnant during the study.\n* Acute disease or fever (≥38°C) at time of vaccination.\n* History of Guillain-Barré Syndrome (GBS).\n* Recurrent or un-controlled neurological disorders or seizures.\n* Serious or unstable chronic illnesses. Please refer to Protocol for full list of Inclusion and Exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT06984094', 'briefTitle': 'First-in-human Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clover Biopharmaceuticals, Ltd'}, 'officialTitle': 'A Phase 1, Randomized, Observer-blind, First-in-human Study to Describe the Safety, Reactogenicity and Immunogenicity of SCB-1022 and SCB-1033 in Healthy Older Adults Aged 60-85 Years', 'orgStudyIdInfo': {'id': 'CLO-SCB-1033-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (SCB-1022 dose level 1)', 'description': '24 adults to receive dose level 1 of SCB-1022 at Day 1', 'interventionNames': ['Biological: SCB-1022']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (SCB-1022 dose level 2)', 'description': '24 adults to receive dose level 2 of SCB-1022 at Day 1', 'interventionNames': ['Biological: SCB-1022']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 (SCB-1033 dose level 1)', 'description': '24 adults to receive dose level 1 of SCB-1033 at Day 1', 'interventionNames': ['Biological: SCB-1033']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4 (SCB-1019T)', 'description': '24 adults to receive SCB-1019T at Day 1', 'interventionNames': ['Biological: SCB-1019T']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5 (SCB-1022 dose level 3)', 'description': '24 adults to receive dose level 3 of SCB-1022 at Day 1', 'interventionNames': ['Biological: SCB-1022']}, {'type': 'EXPERIMENTAL', 'label': 'Group 6 (SCB-1033 dose level 2)', 'description': '24 adults to receive dose level 2 of SCB-1033 at Day 1', 'interventionNames': ['Biological: SCB-1033']}, {'type': 'EXPERIMENTAL', 'label': 'Group 7 (SCB-1033 dose level 3)', 'description': '24 adults to receive dose level 3 of SCB-1033 at Day 1', 'interventionNames': ['Biological: SCB-1033']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 8 (SCB-1019T)', 'description': '24 adults to receive SCB-1019T at Day 1', 'interventionNames': ['Biological: SCB-1019T']}], 'interventions': [{'name': 'SCB-1019T', 'type': 'BIOLOGICAL', 'description': 'SCB-1019T (bivalent recombinant RSV vaccine candidate) consists of two recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)) and RSV B strain (SCB-1019T(B)).', 'armGroupLabels': ['Group 4 (SCB-1019T)', 'Group 8 (SCB-1019T)']}, {'name': 'SCB-1022', 'type': 'BIOLOGICAL', 'description': 'SCB-1022 (combination recombinant RSV-hMPV vaccine candidate) consists of three recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)), RSV B strain (SCB-1019T(B)), and hMPV (SCB-1021).', 'armGroupLabels': ['Group 1 (SCB-1022 dose level 1)', 'Group 2 (SCB-1022 dose level 2)', 'Group 5 (SCB-1022 dose level 3)']}, {'name': 'SCB-1033', 'type': 'BIOLOGICAL', 'description': 'SCB-1033 (combination recombinant RSV-hMPV-PIV3 vaccine candidate) consists of four recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)), RSV B strain (SCB-1019T(B)), hMPV (SCB-1021) and PIV3 (SCB-1020).', 'armGroupLabels': ['Group 3 (SCB-1033 dose level 1)', 'Group 6 (SCB-1033 dose level 2)', 'Group 7 (SCB-1033 dose level 3)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5067', 'city': 'Adelaide', 'state': 'Southern Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Christopher D Rook, MD', 'role': 'CONTACT', 'email': 'christopher.rook@cmax.com.au', 'phone': '+61 8 7088 7900'}], 'facility': 'Fusion Clinical Research', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'centralContacts': [{'name': 'Xuesong Pei, MD', 'role': 'CONTACT', 'email': 'xuesong.pei@cloverbiopharma.com', 'phone': '+8618515445890'}], 'overallOfficials': [{'name': 'Christopher D Rook, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fusion Clinical Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clover Biopharmaceuticals AUS Pty', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}