Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-20 @ 11:25 AM
Study NCT ID:
NCT02575456
Status:
COMPLETED
Last Update Posted:
2016-09-01
First Post:
2015-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Evaluate the Recombinant Human Type5 Adenovirus Vector Based Ebola Virus Disease Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019142', 'term': 'Hemorrhagic Fever, Ebola'}], 'ancestors': [{'id': 'D006482', 'term': 'Hemorrhagic Fevers, Viral'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018702', 'term': 'Filoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046129', 'term': 'Ebola Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-30', 'studyFirstSubmitDate': '2015-10-11', 'studyFirstSubmitQcDate': '2015-10-13', 'lastUpdatePostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of solicited adverse reactions after vaccination', 'timeFrame': '7 days after vaccination'}, {'measure': 'ELISA antigen-specific assays for antibody to GP responses', 'timeFrame': '14 days after vaccination'}, {'measure': 'ELISA antigen-specific assays for antibody to GP responses', 'timeFrame': '28 days after vaccination'}, {'measure': 'ELISA antigen-specific assays for antibody to GP responses', 'timeFrame': '168 days after vaccination'}], 'secondaryOutcomes': [{'measure': 'Occurrence of unsolicited adverse reactions after vaccination', 'timeFrame': '28 days after vaccination'}, {'measure': 'Occurrence of serious adverse reaction during the whole follow-up period', 'timeFrame': '6 months'}, {'measure': 'Post-vaccination Rate of infected with HIV', 'timeFrame': '6 months'}, {'measure': 'Neutralizing antibody titers response to human Ad5', 'timeFrame': '14 days after vaccination'}, {'measure': 'Neutralizing antibody titers response to human Ad5', 'timeFrame': '28 days after vaccination'}, {'measure': 'Neutralizing antibody titers response to human Ad5', 'timeFrame': '168 days after vaccination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ebola Disease']}, 'descriptionModule': {'briefSummary': 'A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults Aged Between 18 and 50 years in Sierra Leone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged between 18 and 50 years\n* Able to understand the content of informed consent and signed the informed consent\n* Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months).\n* Negative in HIV diagnostic blood test on day of enrollment\n* Axillary temperature ≤37.0°C on the day of enrollment\n* Non-pregnant females with a negative result in the urine pregnancy test on day of enrollment\n* General good health as established by medical history and physical examination.\n\nExclusion Criteria:\n\n* Infected by Ebola virus (inquiry)\n* Vaccination with other Ebola vaccine (inquiry)\n* HIV infection or other serious immunodeficiency disease (inquiry)\n* Allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV, such as mannitol\n* Family history of brain or mental disease\n* Woman who is pregnant or breast-feeding\n* Any acute fever disease or infections in last 7 days\n* Major congenital defects or not well-controlled chronic illness\n* Asplenia or functional asplenia\n* Platelet disorder or other bleeding disorder\n* Faint at the sight of blood or needles.\n* Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months\n* Prior administration of other research medicines in last 1 month\n* Prior administration of attenuated vaccine(s) in the last one month\n* Prior administration of inactivated vaccine(s) in the last 14 days\n* Any condition that in the opinion of the investigators may interfere with the participants' compliance or evaluation of study objectives"}, 'identificationModule': {'nctId': 'NCT02575456', 'briefTitle': 'A Clinical Trial to Evaluate the Recombinant Human Type5 Adenovirus Vector Based Ebola Virus Disease Vaccine', 'organization': {'class': 'NETWORK', 'fullName': 'Jiangsu Province Centers for Disease Control and Prevention'}, 'officialTitle': 'A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults in Sierra Leone', 'orgStudyIdInfo': {'id': 'JSVCT024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': '(4×10\\^10vp/vial, 4 vials): 1 ml sterilization injection water per dose to dilute 2 vials (4×10\\^10 vp/vial), one shot in each arm, total dose of 1.6×10\\^11vp. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection', 'interventionNames': ['Biological: Ebola Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': '(4×10\\^10vp/vial, 2 vials): 1 ml sterilization injection water per dose to dilute 1 vial (4×10\\^10vp/vial), total dose of 8×10\\^10vp, one shot in each arm. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection', 'interventionNames': ['Biological: Ebola Vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group C', 'description': '(0 vp/ vial, 2 vials):1 ml sterilization injection water per dose to dilute 1 vial, total dose of 0 vp. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Ebola Vaccine', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'control', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Freetown', 'country': 'Sierra Leone', 'facility': 'Dr. Alie H Wurie', 'geoPoint': {'lat': 8.48714, 'lon': -13.2356}}], 'overallOfficials': [{'name': 'Alie H Wurie', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ministry of Health & Sanitation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu Province Centers for Disease Control and Prevention', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Beijing Institute of Biotechnology', 'class': 'OTHER'}, {'name': 'Tianjin Cansino Biotechnology Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}