Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-30 @ 3:37 AM
Study NCT ID:
NCT01015703
Status:
COMPLETED
Last Update Posted:
2014-09-15
First Post:
2009-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-label Safety and Tolerability Study of CoVaccine HT™ in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'angela.ogden@btgplc.com', 'phone': '610-278-1660', 'title': 'SVP Clinical Development', 'organization': 'BTG International Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '1 mg Dose', 'description': '1 mg CoVaccine HT', 'otherNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2 mg Dose', 'description': '2 mg CoVaccine HT', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '5 mg Dose', 'description': '5 mg CoVaccine HT', 'otherNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '7 mg Dose', 'description': '7 mg CoVaccine HT', 'otherNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '10 mg Dose', 'description': '10 mg CoVaccine HT', 'otherNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'influenza-like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '1 mg Dose', 'description': '1 mg CoVaccine HT'}, {'id': 'OG001', 'title': '2 mg Dose', 'description': '2 mg CoVaccine HT'}, {'id': 'OG002', 'title': '5 mg Dose', 'description': '5 mg CoVaccine HT'}, {'id': 'OG003', 'title': '7 mg Dose', 'description': '7 mg CoVaccine HT'}, {'id': 'OG004', 'title': '10 mg Dose', 'description': '10 mg CoVaccine HT'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Duration of study', 'description': 'Safety/tolerability study design of 5 doses of test article administered to healthy volunteers. Each dose was injected 21 days apart. Participants were withdrawn upon experiencing any adverse event.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 mg Dose', 'description': '1 mg CoVaccine HT'}, {'id': 'FG001', 'title': '2 mg Dose', 'description': '2 mg CoVaccine HT'}, {'id': 'FG002', 'title': '5 mg Dose', 'description': '5 mg CoVaccine HT'}, {'id': 'FG003', 'title': '7 mg Dose', 'description': '7 mg CoVaccine HT'}, {'id': 'FG004', 'title': '10 mg Dose', 'description': '10 mg CoVaccine HT'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '50', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': '1 mg Dose', 'description': '1 mg CoVaccine HT'}, {'id': 'BG001', 'title': '2 mg Dose', 'description': '2 mg CoVaccine HT'}, {'id': 'BG002', 'title': '5 mg Dose', 'description': '5 mg CoVaccine HT'}, {'id': 'BG003', 'title': '7 mg Dose', 'description': '7 mg CoVaccine HT'}, {'id': 'BG004', 'title': '10 mg Dose', 'description': '10 mg CoVaccine HT'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '11', 'groupId': 'BG000'}, {'value': '46', 'spread': '11', 'groupId': 'BG001'}, {'value': '49', 'spread': '9', 'groupId': 'BG002'}, {'value': '44', 'spread': '15', 'groupId': 'BG003'}, {'value': '36', 'spread': '9', 'groupId': 'BG004'}, {'value': '42', 'spread': '10', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '45', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population, subjects who received at least one dose of test article'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-09', 'studyFirstSubmitDate': '2009-11-17', 'resultsFirstSubmitDate': '2014-06-04', 'studyFirstSubmitQcDate': '2009-11-17', 'lastUpdatePostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-09', 'studyFirstPostDateStruct': {'date': '2009-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Events', 'timeFrame': 'Duration of study', 'description': 'Safety/tolerability study design of 5 doses of test article administered to healthy volunteers. Each dose was injected 21 days apart. Participants were withdrawn upon experiencing any adverse event.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vaccine, hypertension'], 'conditions': ['Vaccine']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to explore the safety and tolerability of CoVaccine HT in healthy male and female volunteers. In this study volunteers will receive intramuscular injections of CoVaccine HT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult males or females of non child-bearing potential aged 25 to 65 years inclusive and between 19 and 35 kg/m2 body mass index (BMI)\n* Generally healthy as determined by pre study medical history, physical examination, 12 lead ECG.\n* Negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening and rapid influenza diagnostic test at admission.\n\nExclusion Criteria:\n\n* History of alcohol abuse in the last 5 years or drug abuse at any time, current significant alcohol consumption.\n* Fever, active infections (such as influenza) and acute gastrointestinal symptoms following prior to first dosing\n* Subjects with a previous serious reaction to a vaccine, such as angioedema or anaphylaxis'}, 'identificationModule': {'nctId': 'NCT01015703', 'briefTitle': 'Open-label Safety and Tolerability Study of CoVaccine HT™ in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'BTG International Inc.'}, 'officialTitle': 'A Phase 1, Open-Label, Dose Escalation Study of the Safety and Tolerability of CoVaccine HT™ in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'PR002-CLN-pro010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CoVaccine HT', 'interventionNames': ['Biological: CoVaccine HT']}], 'interventions': [{'name': 'CoVaccine HT', 'type': 'BIOLOGICAL', 'description': 'intramuscular injection, dose escalation', 'armGroupLabels': ['CoVaccine HT']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 1YR', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Quintiles Drug Research Unit', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Darren Wilbraham, MB., BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quintiles, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BTG International Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}