Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT00511095
Status:
COMPLETED
Last Update Posted:
2019-04-30
First Post:
2007-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006505', 'term': 'Hepatitis'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017325', 'term': 'Hepatitis B Vaccines'}], 'ancestors': [{'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '510-848-5100', 'title': 'Robert Janssen MD \\ VP & Chief Medical Officer', 'organization': 'Dynavax Technologies, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'HEPLISAV', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 0 and Week 4', 'otherNumAtRisk': 207, 'otherNumAffected': 59, 'seriousNumAtRisk': 207, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 31}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Hernia obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Postoperative ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Local and Systemic Post-injection Reaction Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HEPLISAV (Week 0)', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 0'}, {'id': 'OG001', 'title': 'HEPLISAV (Week 4)', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 4'}], 'classes': [{'title': 'Local Reaction: Injection', 'categories': [{'measurements': [{'value': '38.2', 'groupId': 'OG000'}, {'value': '37.9', 'groupId': 'OG001'}]}]}, {'title': 'Systemic Reaction: Injection', 'categories': [{'measurements': [{'value': '37.2', 'groupId': 'OG000'}, {'value': '33.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days post-injection for post-injection reactions at Week 0 and Week 4', 'description': 'Local and Systemic post-injection reactions.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: Subjects who received at least 1 study injection and had any post-baseline safety data'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}, {'value': '196', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HEPLISAV (Week 4)', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 4'}, {'id': 'OG001', 'title': 'HEPLISAV (Week 8)', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 8'}, {'id': 'OG002', 'title': 'HEPLISAV (Week 12)', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 12'}, {'id': 'OG003', 'title': 'HEPLISAV (Week 28)', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 28'}], 'classes': [{'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000'}, {'value': '84.9', 'groupId': 'OG001'}, {'value': '93.4', 'groupId': 'OG002'}, {'value': '95.4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, 12 and 28', 'description': 'Seroprotective Immune Response', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: Enrolled subjects who received at least 1 study injection irrespective of available immune response data.'}, {'type': 'SECONDARY', 'title': 'Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HEPLISAV', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 0 and Week 4'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '16.8'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '69.1', 'upperLimit': '136.6'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '170.7', 'groupId': 'OG000', 'lowerLimit': '127.9', 'upperLimit': '227.7'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '349.4', 'groupId': 'OG000', 'lowerLimit': '271.8', 'upperLimit': '449.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Weeks 4, 8, 12, and 28', 'description': 'Measurement of Serum GMC', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: Enrolled subjects who received at least 1 study injection irrespective of available immune response data.\n\nNote: "Number Analyzed" is the number of subjects with nonmissing concentrations at that visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HEPLISAV', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 0 and Week 4'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '207'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'HEPLISAV', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 0 and Week 4'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '207', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.0', 'spread': '8.36', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '133', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '207', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'dispFirstSubmitDate': '2010-06-17', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2007-07-25', 'dispFirstSubmitQcDate': '2010-06-17', 'resultsFirstSubmitDate': '2017-03-01', 'studyFirstSubmitQcDate': '2007-08-01', 'dispFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-01', 'studyFirstPostDateStruct': {'date': '2007-08-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Local and Systemic Post-injection Reaction Rates', 'timeFrame': 'Within 7 days post-injection for post-injection reactions at Week 0 and Week 4', 'description': 'Local and Systemic post-injection reactions.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28.', 'timeFrame': 'Weeks 4, 8, 12 and 28', 'description': 'Seroprotective Immune Response'}, {'measure': 'Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28', 'timeFrame': 'Weeks 4, 8, 12, and 28', 'description': 'Measurement of Serum GMC'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis B vaccine', 'HBV vaccine', 'Hepatitis B', 'Hepatitis', 'HBV', 'Vaccine', '1018', 'HBsAg'], 'conditions': ['Hepatitis B']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.dynavax.com', 'label': 'Dynavax Webpage'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to further evaluate the safety and seroprotective immune response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects 11-55 years old. The primary hypothesis is that HEPLISAV™ is well tolerated.', 'detailedDescription': 'This study will evaluate the safety and efficacy of two injections of HEPLISAV™ in subjects 11 to 55 years old. About 200 subjects will be included in the study. Once subjects have been consented and screened, they will receive a total of two injections over a 28-day period, with follow-up visits at 8, 12 and 28 weeks. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.\n\nComparison: This study does not include a control treatment; all subjects will receive treatment with HEPLISAV™.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to give written informed consent\n* Women of childbearing potential must be willing to consistently use a highly effective method of birth control\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding\n* Any previous HBV infection\n* Previous vaccination (1 or more doses) with any HBV vaccine\n* Any previous autoimmune diseases\n* Are at high risk for recent exposure to HBV, Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)\n* Received any blood products or antibodies within 3 months prior to study entry\n* Ever received an injection with DNA plasmids or oligonucleotides\n* Received any vaccines within 4 weeks prior to study entry\n* Received any other investigational medicinal agent within 4 weeks prior to study entry'}, 'identificationModule': {'nctId': 'NCT00511095', 'briefTitle': 'Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dynavax Technologies Corporation'}, 'officialTitle': 'An Open-Label Study of Safety and Immunogenicity in Subjects Following Injection With Two Doses of HEPLISAV™', 'orgStudyIdInfo': {'id': 'DV2-HBV-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HEPLISAV', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) Intramuscular (IM) injection 0.5mL', 'interventionNames': ['Biological: HEPLISAV']}], 'interventions': [{'name': 'HEPLISAV', 'type': 'BIOLOGICAL', 'description': 'Intramuscular (IM) injections 0.5mL on Day 0 and Week 4', 'armGroupLabels': ['HEPLISAV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44512', 'city': 'Boardman', 'state': 'Ohio', 'country': 'United States', 'facility': 'Beeghley Medical Park', 'geoPoint': {'lat': 41.02423, 'lon': -80.66285}}, {'zip': '16127', 'city': 'Grove City', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Family Healthcare Partners', 'geoPoint': {'lat': 41.15784, 'lon': -80.08867}}, {'zip': '15217', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pediatric Alliance Southwestern', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15241', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Primary Physicians Research', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15241', 'city': 'Upper Saint Clair', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Family Practice Medical Associates South', 'geoPoint': {'lat': 40.3359, 'lon': -80.08339}}, {'zip': '15301', 'city': 'Washington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Washington Hospital Family Medicine', 'geoPoint': {'lat': 40.17396, 'lon': -80.24617}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Metropolitan Research', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}], 'overallOfficials': [{'name': 'Eduardo Martins, MD, DPhil', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dynavax Technologies Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dynavax Technologies Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}