Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-03-22 @ 6:51 AM
Study NCT ID:
NCT01867957
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2013-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Anthrax Vaccine, GC1109
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000881', 'term': 'Anthrax'}], 'ancestors': [{'id': 'D016863', 'term': 'Bacillaceae Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014611', 'term': 'Vaccination'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D016233', 'term': 'Immunotherapy, Active'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011322', 'term': 'Primary Prevention'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003140', 'term': 'Communicable Disease Control'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-03', 'studyFirstSubmitDate': '2013-05-30', 'studyFirstSubmitQcDate': '2013-05-30', 'lastUpdatePostDateStruct': {'date': '2013-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Event', 'timeFrame': '0 - 28 Days'}], 'secondaryOutcomes': [{'measure': 'Anti-protective antigen(PA) antibody level (by TNA)', 'timeFrame': 'Day 14, Day 28'}, {'measure': 'Anti-PA Immunoglobulin G (IgG) (by ELISA)', 'timeFrame': 'Day 14, Day 28'}]}, 'conditionsModule': {'keywords': ['anthrax', 'vaccine', 'bioterrorism', 'efficacy', 'safety'], 'conditions': ['Anthrax']}, 'descriptionModule': {'briefSummary': '1. BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and effective in preclinical studies.\n2. OBJECTIVE\n\n \\- To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy male volunteers.\n3. STUDY DESIGN\n\n * single-blinded\n * randomized\n * placebo controlled\n * phase 1 study'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy male subjects between 18 and 45 years of age at the time of screening visit\n2. 18.5kg/m2 ≤BMI \\< 30kg/m2 at the time of screening visit\n3. Subjects without congenital or chronic disorder\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01867957', 'briefTitle': 'Efficacy and Safety of Anthrax Vaccine, GC1109', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Single Blind, Randomized, Placebo Control, Phase I Study to Evaluate the Safety and Immunogenicity of the GC1109 Administered by the Intramuscular Route in Healthy Men', 'orgStudyIdInfo': {'id': 'GC1109_P1_v1.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-dose GC1109', 'interventionNames': ['Biological: Low-dose GC1109']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Low-dose Placebo', 'interventionNames': ['Biological: Low-dose Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'High-dose GC1109', 'interventionNames': ['Biological: High-dose GC1109']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'High-dose Placebo', 'interventionNames': ['Biological: High-dose Placebo']}], 'interventions': [{'name': 'Low-dose GC1109', 'type': 'BIOLOGICAL', 'otherNames': ['GC1109 50ug/dose (0.5 ml) vaccination'], 'description': '50ug/dose', 'armGroupLabels': ['Low-dose GC1109']}, {'name': 'High-dose GC1109', 'type': 'BIOLOGICAL', 'otherNames': ['GC1109 100ug/dose (1.0 ml) vaccination'], 'description': '100ug/dose', 'armGroupLabels': ['High-dose GC1109']}, {'name': 'Low-dose Placebo', 'type': 'BIOLOGICAL', 'otherNames': ['0.9% Saline 0.5 mL vaccination'], 'description': '0.9% Saline 0.5 mL', 'armGroupLabels': ['Low-dose Placebo']}, {'name': 'High-dose Placebo', 'type': 'BIOLOGICAL', 'otherNames': ['0.9% Saline 1.0 mL vaccination'], 'description': '0.9% Saline 1.0 mL', 'armGroupLabels': ['High-dose Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Myoung-don Oh, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Green Cross Corporation', 'class': 'INDUSTRY'}, {'name': 'LSK Global Pharma Services Co. Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Division of Infectious Diseases, Department of Internal Medicine', 'investigatorFullName': 'Myoung-don Oh', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}