Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT04793620
Status:
TERMINATED
Last Update Posted:
2022-11-01
First Post:
2021-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pertussis Acellular Vaccine Adjuvanted With TQL1055
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014917', 'term': 'Whooping Cough'}], 'ancestors': [{'id': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Sequential-group dose-escalation study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'whyStopped': 'financial constraints', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-28', 'studyFirstSubmitDate': '2021-03-04', 'studyFirstSubmitQcDate': '2021-03-10', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reactogenicity', 'timeFrame': '7 days', 'description': 'Solicited local and systemic adverse events'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '365 days', 'description': 'Adverse Events/Serious Adverse Events'}, {'measure': 'Incidence of abnormal laboratory test results', 'timeFrame': '28 days', 'description': 'Incidence of abnormal laboratory test results'}, {'measure': 'Immunogenicity', 'timeFrame': '28 days', 'description': 'Anti-Pertussis Toxin antibodies'}, {'measure': 'Immunogenicity', 'timeFrame': '365 days', 'description': 'Anti-Pertussis Toxin antibodies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vaccine', 'adjuvant'], 'conditions': ['Pertussis']}, 'descriptionModule': {'briefSummary': 'This is a phase 1 study to evaluate the safety and immunogenicity of the semisynthetic saponin adjuvant TQL1055 administered in combination with an acellular pertussis vaccine.', 'detailedDescription': 'The recent increase in the incidence of pertussis has prompted the need for improvements to current acellular pertussis vaccines. Use of novel adjuvants is one approach to such improvement. TQL1055 is a rationally designed, semisynthetic analog of the licensed Quillaja saponin (QS)-21. It has been designed to maintain adjuvant activity with improved tolerability and greater ease of manufacture.\n\nThis is a Phase 1, randomized, double blind, active-controlled sequential-group study, designed to evaluate the safety, tolerability, and immunogenicity of the combination of TQL1055 and acellular pertussis vaccine. The dose of TQL1055 will increase by group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* 18 to 50 years of age\n* General good health\n* BMI between 17 and 35 kg/m2\n* Not of childbearing potential OR using adequate contraception\n\nKey Exclusion Criteria:\n\n* Pregnant or lactating\n* Prior medical condition that could adversely affect subject safety\n* Clinically significant abnormal laboratory parameter\n* Current acute febrile illness\n* Contraindication to intramuscular injection\n* Contraindication to pertussis vaccination\n* Received pertussis vaccine within 3 years'}, 'identificationModule': {'nctId': 'NCT04793620', 'briefTitle': 'Pertussis Acellular Vaccine Adjuvanted With TQL1055', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adjuvance Technologies, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Double Blind, Active-Controlled Dose-Escalation Study to Assess the Safety and Immunogenicity of Pertussis Acellular Vaccine Adjuvanted With TQL1055 (PAVA)', 'orgStudyIdInfo': {'id': 'V1.1-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TQL1055', 'description': 'TQL1055 + acellular pertussis vaccine', 'interventionNames': ['Other: TQL1055', 'Biological: Acellular pertussis vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acellular pertussis vaccine', 'description': 'Acellular pertussis vaccine', 'interventionNames': ['Biological: Acellular pertussis vaccine']}], 'interventions': [{'name': 'TQL1055', 'type': 'OTHER', 'description': 'Semisynthetic saponin adjuvant', 'armGroupLabels': ['TQL1055']}, {'name': 'Acellular pertussis vaccine', 'type': 'BIOLOGICAL', 'description': 'Acellular pertussis vaccine', 'armGroupLabels': ['Acellular pertussis vaccine', 'TQL1055']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brisbane', 'country': 'Australia', 'facility': 'Q-Pharm', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}], 'overallOfficials': [{'name': 'Sean R Bennett, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Adjuvance Technologies, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adjuvance Technologies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}