Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
Study NCT ID:
NCT05770895
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2023-03-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of HBV Therapeutic Vaccines GS-2829 and GS-6779 in Healthy Participants and Participants With Chronic Hepatitis B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2023-03-01', 'studyFirstSubmitQcDate': '2023-03-14', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'First dose date to end of study followed up to 24 weeks post last dose (Up to Day 225 for Cohorts 1 and 2; Up to Day 309 for Cohorts 3-8)'}, {'measure': 'Percentage of Participants With Treatment-emergent Laboratory Abnormalities', 'timeFrame': 'First dose date to end of study followed up to 24 weeks post last dose (Up to Day 225 for Cohorts 1 and 2; Up to Day 309 for Cohorts 3-8)'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants With Vaccine-induced Immune Response', 'timeFrame': 'First dose date to end of study followed up to 24 weeks post last dose (Up to Day 225 for Cohorts 1 and 2; Up to Day 309 for Cohorts 3-8)'}, {'measure': 'Magnitude of Vaccine-Induced Immune Responses as Measured by T-Cell Levels (T-Cell Responses to HBV)', 'timeFrame': 'First dose date to end of study followed up to 24 weeks post last dose (Up to Day 225 for Cohorts 1 and 2; Up to Day 309 for Cohorts 3-8)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis B']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study/?id=GS-US-642-5670', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to learn more about GS-2829 and GS-6779 in healthy participants and participants with CHB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\nPhase 1a and 1b:\n\n* Body mass index (BMI) of ≤ 32.0 kg/m\\^2.\n* Non-diabetic without impaired glucose tolerance.\n* No evidence of cardiac disease based on 12 lead ECG.\n\nPhase 1a (Healthy Individuals) only:\n\n* Aged 18 through 60 years.\n* No history of Hepatitis B infection with a negative Hepatitis B virus (HBV) core Antibody.\n\nPhase 1b (Virally suppressed CHB individuals):\n\n* Aged 18 through 65 years.\n* Documented CHB and HBsAg ≤ 5000 IU/mL at screening.\n* No evidence of advanced fibrosis by Fibroscan (defined as Fibroscan \\< 9 kPa within 6 months of screening).\n* Diagnosed with chronic hepatitis B on suppressive oral antiviral for ≥ 6 months.\n\nKey Exclusion Criteria:\n\nPhase 1a and 1b:\n\n* Use of any systemic antibiotics within 30 days of screening.\n* Receipt of any HBV vaccine within 12 months of screening visit or planning HBV vaccination during the study period.\n* Receipt of any investigational product within 3 months or vaccine within 3 months of screening (with the exception of influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, which if needed, should be administered at least 14 days before or after an investigational product administration).\n* Receipt of immunoglobulin or other blood products within 3 months of screening.\n* Positive serum pregnancy test at screening or positive urine pregnancy on Day 1.\n* Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or is expected to receive these agents during the study (eg, corticosteroids, immunoglobulins, other immune or cytokine-based therapies).\n* Participation in any other clinical study (including observational studies) without prior approval from the sponsor is prohibited while participating in the study.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05770895', 'briefTitle': 'Study of HBV Therapeutic Vaccines GS-2829 and GS-6779 in Healthy Participants and Participants With Chronic Hepatitis B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 1a/1b Study to Evaluate the Safety and Tolerability of Repeated Doses of Nonreplicating Arenavirus Vector Therapeutic Vaccines GS-2829 and GS-6779 in Healthy Participants and Participants With Chronic Hepatitis B (CHB)', 'orgStudyIdInfo': {'id': 'GS-US-642-5670'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: GS-2829 Dose A or Placebo', 'description': 'Healthy participants will receive GS-2829 Dose A or placebo for GS-2829.', 'interventionNames': ['Biological: GS-2829', 'Biological: Placebo for GS-2829']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: GS-6779 Dose B or Placebo', 'description': 'Healthy participants will receive GS-6779 Dose B or placebo for GS-6779.', 'interventionNames': ['Biological: GS-6779', 'Biological: Placebo for GS-6779']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo', 'description': 'Healthy participants will receive GS-2829 Dose A or placebo for GS-2829 and GS-6779 Dose B or placebo for GS-6779.', 'interventionNames': ['Biological: GS-2829', 'Biological: GS-6779', 'Biological: Placebo for GS-2829', 'Biological: Placebo for GS-6779']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo', 'description': 'Healthy participants will receive GS-2829 Dose C or placebo for GS-2829 and GS-6779 Dose D or placebo for GS-6779.', 'interventionNames': ['Biological: GS-2829', 'Biological: GS-6779', 'Biological: Placebo for GS-2829', 'Biological: Placebo for GS-6779']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo', 'description': 'Participants with Chronic Hepatitis B (CHB) who are virally suppressed will receive GS-2829 Dose A or placebo for GS-2829 and GS-6779 Dose B or placebo for GS-6779.', 'interventionNames': ['Biological: GS-2829', 'Biological: GS-6779', 'Biological: Placebo for GS-2829', 'Biological: Placebo for GS-6779']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 6: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo', 'description': 'Participants with Chronic Hepatitis B (CHB) who are virally suppressed will receive GS-2829 Dose C or placebo for GS-2829 and GS-6779 Dose D or placebo for GS-6779.', 'interventionNames': ['Biological: GS-2829', 'Biological: GS-6779', 'Biological: Placebo for GS-2829', 'Biological: Placebo for GS-6779']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 7: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo', 'description': 'Participants with CHB who are virally suppressed will receive GS-2829 Dose C or placebo for GS-2829 and GS-6779 Dose D or placebo for GS-6779.', 'interventionNames': ['Biological: GS-2829', 'Biological: GS-6779', 'Biological: Placebo for GS-2829', 'Biological: Placebo for GS-6779']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 8: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo', 'description': 'Healthy participants will receive GS-2829 Dose C or placebo for GS-2829 and GS-6779 Dose D or placebo for GS-6779.', 'interventionNames': ['Biological: GS-2829', 'Biological: GS-6779', 'Biological: Placebo for GS-2829', 'Biological: Placebo for GS-6779']}], 'interventions': [{'name': 'GS-2829', 'type': 'BIOLOGICAL', 'description': 'Administered intramuscularly', 'armGroupLabels': ['Cohort 1: GS-2829 Dose A or Placebo', 'Cohort 3: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo', 'Cohort 4: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo', 'Cohort 5: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo', 'Cohort 6: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo', 'Cohort 7: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo', 'Cohort 8: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo']}, {'name': 'GS-6779', 'type': 'BIOLOGICAL', 'description': 'Administered intramuscularly', 'armGroupLabels': ['Cohort 2: GS-6779 Dose B or Placebo', 'Cohort 3: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo', 'Cohort 4: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo', 'Cohort 5: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo', 'Cohort 6: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo', 'Cohort 7: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo', 'Cohort 8: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo']}, {'name': 'Placebo for GS-2829', 'type': 'BIOLOGICAL', 'description': 'Administered intramuscularly', 'armGroupLabels': ['Cohort 1: GS-2829 Dose A or Placebo', 'Cohort 3: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo', 'Cohort 4: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo', 'Cohort 5: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo', 'Cohort 6: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo', 'Cohort 7: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo', 'Cohort 8: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo']}, {'name': 'Placebo for GS-6779', 'type': 'BIOLOGICAL', 'description': 'Administered intramuscularly', 'armGroupLabels': ['Cohort 2: GS-6779 Dose B or Placebo', 'Cohort 3: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo', 'Cohort 4: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo', 'Cohort 5: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo', 'Cohort 6: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo', 'Cohort 7: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo', 'Cohort 8: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1010', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'New Zealand Clinical Research (NZCR)', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '60002', 'city': 'Chiayi City', 'country': 'Taiwan', 'facility': 'Chia-Yi Christian Hospital', 'geoPoint': {'lat': 23.47917, 'lon': 120.44889}}, {'zip': '600', 'city': 'Chiayi City', 'country': 'Taiwan', 'facility': 'St. Martin De Porres Hospital', 'geoPoint': {'lat': 23.47917, 'lon': 120.44889}}, {'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '82445', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'E-DA Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '833', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '7428', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '100229', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '33305', 'city': 'Taoyuan', 'country': 'Taiwan', 'facility': 'Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}