Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT06997627
Status:
RECRUITING
Last Update Posted:
2025-07-10
First Post:
2025-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C505143', 'term': 'Boostrix'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2025-05-15', 'studyFirstSubmitQcDate': '2025-05-21', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Solicited adverse events occurring by day 14 after administration of the investigational product', 'timeFrame': '14 days after administration of the IP'}, {'measure': 'Unsolicited adverse events occurring by day 28 after administration of the investigational product', 'timeFrame': '28 days after administration of the IP'}, {'measure': 'Acute adverse events occurring within 30 minutes after administration of the investigational product', 'timeFrame': '30 minutes after administration of the IP'}, {'measure': 'Serious adverse events (SAE) and adverse events of special interest (AESI) occurring up to 180 days after administration of the investigational product', 'timeFrame': '180 days after administration of the IP'}, {'measure': 'Clinically significant findings in vital signs, laboratory tests, 12-lead electrocardiograms, and physical examinations', 'timeFrame': '28 days after administration of the IP'}], 'secondaryOutcomes': [{'measure': 'Antibody rates for diphtheria and tetanus on day 28 after administration of the investigational product', 'timeFrame': '28 days after administration of the IP'}, {'measure': 'Boosting response rates for diphtheria, tetanus, and pertussis on day 28 after administration of the investigational product', 'timeFrame': '28 days after administration of the IP', 'description': 'Boosting response rate: 1) If less than 0.1 IU/ml before vaccination, it should be 0.4 IU/ml or higher after the vaccination, or 2) if not less than 0.1 IU/ml before vaccination, it should be 4 times or higher after the vaccination.'}, {'measure': 'Geometric mean concentrations (GMC) of antibodies against diphtheria, tetanus, and pertussis antitoxins (anti-PT, anti-FHA, anti-PRN) on day 28 after administration of the investigational product', 'timeFrame': '28 days after administration of the IP'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tetanus-diphtheria-acellular Pertussis (Tdap)']}, 'descriptionModule': {'briefSummary': 'This clinical trial consists of two parts: Part 1, which explores safety, and Part 2, which examines both safety and efficacy (immunogenicity). Part 1 is a single-center, open-label, single-group study, while Part 2 is designed as a multicenter, double-blind, randomized, active-controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults aged 19 to 64 years old as of the date of written consent.\n* Individuals with no history of vaccination with a vaccine containing diphtheria, tetanus, or pertussis antigens within the past 2 years prior to administration of the investigational product.\n\nExclusion Criteria:\n\n* Individuals who have received a vaccine within 4 weeks prior to administration of the investigational product.\n* Individuals with a history of Tdap vaccination prior to administration of the investigational product.\n* Pregnant and breastfeeding women.\n* Individuals who have participated in other clinical trials involving investigational products/devices within 6 months prior to administration of the investigational product.'}, 'identificationModule': {'nctId': 'NCT06997627', 'briefTitle': 'A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'GC Biopharma Corp'}, 'officialTitle': 'An Open(Part 1), Single-arm(Part 1), Randomized(Part 2), Double-blind(Part 2), Active-controlled(Part 2) Phase I/II Clinical Trial to Evaluate the Safety and Efficacy (Immunogenicity) of GC3111B in Healthy Adults', 'orgStudyIdInfo': {'id': 'GC3111B_Tdap_P1201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GC3111B', 'description': 'Participants randomized to receive a single dose of GC3111B vaccine.', 'interventionNames': ['Biological: GC3111B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Boostrix®', 'description': 'Participants randomized to receive a single dose of Boostrix® vaccine.', 'interventionNames': ['Biological: Boostrix®']}], 'interventions': [{'name': 'GC3111B', 'type': 'BIOLOGICAL', 'description': '0.5 mL, Intramuscular injection', 'armGroupLabels': ['GC3111B']}, {'name': 'Boostrix®', 'type': 'BIOLOGICAL', 'description': '0.5 mL, Intramuscular injection', 'armGroupLabels': ['Boostrix®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1021', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Junghyun Choi, MD, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Minji Ko', 'role': 'CONTACT', 'email': 'minji.ko@gccorp.com', 'phone': '+82-31-260-9143'}, {'name': 'Sujin Lee', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GC Biopharma Corp', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}