Chronic Hepatitis B Clinical Trial
Official title:
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)
Verified date | April 2024 |
Source | Gilead Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this clinical study is to learn more about GS-2829 and GS-6779 in healthy participants and participants with CHB.
Status | Active, not recruiting |
Enrollment | 83 |
Est. completion date | January 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Key Inclusion Criteria: Phase 1a and 1b: - Body mass index (BMI) of = 32.0 kg/m^2. - Non-diabetic without impaired glucose tolerance. - No evidence of cardiac disease based on 12 lead ECG. Phase 1a (Healthy Individuals) only: - Aged 18 through 60 years. - No history of Hepatitis B infection with a negative Hepatitis B virus (HBV) core Antibody. Phase 1b (Virally suppressed CHB individuals): - Aged 18 through 65 years. - Documented CHB and HBsAg = 5000 IU/mL at screening. - No evidence of advanced fibrosis by Fibroscan (defined as Fibroscan < 9 kPa within 6 months of screening). - Diagnosed with chronic hepatitis B on suppressive oral antiviral for = 6 months. Key Exclusion Criteria: Phase 1a and 1b: - Use of any systemic antibiotics within 30 days of screening. - Receipt of any HBV vaccine within 12 months of screening visit or planning HBV vaccination during the study period. - 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). - Receipt of immunoglobulin or other blood products within 3 months of screening. - Positive serum pregnancy test at screening or positive urine pregnancy on Day 1. - 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). - Participation in any other clinical study (including observational studies) without prior approval from the sponsor is prohibited while participating in the study. Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
New Zealand | New Zealand Clinical Research (NZCR) | Auckland | |
Taiwan | Chia-Yi Christian Hospital | Chiayi City | |
Taiwan | St. Martin De Porres Hospital | Chiayi City | |
Taiwan | Kaohsiung Medical University Hospital | Kaohsiung | |
Taiwan | Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | |
Taiwan | E-DA Hospital | Kaohsiung City | |
Taiwan | National Cheng Kung University Hospital | Tainan City | |
Taiwan | National Taiwan University Hospital | Taipei City | |
Taiwan | Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital | Taoyuan City |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
New Zealand, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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) | ||
Primary | Percentage of Participants With Treatment-emergent Laboratory Abnormalities | 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) | ||
Secondary | Proportion of Participants With Vaccine-induced Immune Response | 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) | ||
Secondary | Magnitude of Vaccine-Induced Immune Responses as Measured by T-Cell Levels (T-Cell Responses to HBV) | 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) |
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