Study of HBV Therapeutic Vaccines GS-2829 and GS-6779 in Healthy Participants and Participants With Chronic Hepatitis B
Phase 1
Completed
- Conditions
- Chronic Hepatitis B
- Interventions
- Biological: Placebo for GS-6779Biological: Placebo for GS-2829
- Registration Number
- NCT05770895
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The goal of this clinical study is to learn more about GS-2829 and GS-6779 in healthy participants and participants with CHB.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2: GS-6779 Dose B or Placebo Placebo for GS-6779 Healthy participants will receive GS-6779 Dose B or placebo for GS-6779. Cohort 1: GS-2829 Dose A or Placebo Placebo for GS-2829 Healthy participants will receive GS-2829 Dose A or placebo for GS-2829. Cohort 4: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo GS-2829 Healthy participants will receive GS-2829 Dose C or placebo for GS-2829 and GS-6779 Dose D or placebo for GS-6779. Cohort 5: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo Placebo for GS-2829 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. Cohort 6: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo GS-6779 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. Cohort 1: GS-2829 Dose A or Placebo GS-2829 Healthy participants will receive GS-2829 Dose A or placebo for GS-2829. Cohort 3: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo Placebo for GS-2829 Healthy participants will receive GS-2829 Dose A or placebo for GS-2829 and GS-6779 Dose B or placebo for GS-6779. Cohort 3: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo Placebo for GS-6779 Healthy participants will receive GS-2829 Dose A or placebo for GS-2829 and GS-6779 Dose B or placebo for GS-6779. Cohort 5: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo Placebo for GS-6779 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. Cohort 8: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo GS-6779 Healthy participants will receive GS-2829 Dose C or placebo for GS-2829 and GS-6779 Dose D or placebo for GS-6779. Cohort 4: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo Placebo for GS-6779 Healthy participants will receive GS-2829 Dose C or placebo for GS-2829 and GS-6779 Dose D or placebo for GS-6779. Cohort 7: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo Placebo for GS-2829 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. Cohort 8: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo Placebo for GS-6779 Healthy participants will receive GS-2829 Dose C or placebo for GS-2829 and GS-6779 Dose D or placebo for GS-6779. Cohort 4: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo Placebo for GS-2829 Healthy participants will receive GS-2829 Dose C or placebo for GS-2829 and GS-6779 Dose D or placebo for GS-6779. Cohort 6: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo Placebo for GS-2829 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. Cohort 8: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo Placebo for GS-2829 Healthy participants will receive GS-2829 Dose C or placebo for GS-2829 and GS-6779 Dose D or placebo for GS-6779. Cohort 7: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo Placebo for GS-6779 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. Cohort 5: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo GS-2829 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. Cohort 7: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo GS-2829 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. Cohort 6: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo Placebo for GS-6779 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. Cohort 3: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo GS-6779 Healthy participants will receive GS-2829 Dose A or placebo for GS-2829 and GS-6779 Dose B or placebo for GS-6779. Cohort 2: GS-6779 Dose B or Placebo GS-6779 Healthy participants will receive GS-6779 Dose B or placebo for GS-6779. Cohort 4: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo GS-6779 Healthy participants will receive GS-2829 Dose C or placebo for GS-2829 and GS-6779 Dose D or placebo for GS-6779. Cohort 5: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo GS-6779 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. Cohort 3: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo GS-2829 Healthy participants will receive GS-2829 Dose A or placebo for GS-2829 and GS-6779 Dose B or placebo for GS-6779. Cohort 6: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo GS-2829 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. Cohort 8: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo GS-2829 Healthy participants will receive GS-2829 Dose C or placebo for GS-2829 and GS-6779 Dose D or placebo for GS-6779. Cohort 7: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo GS-6779 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.
- Primary Outcome Measures
Name Time Method 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) 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)
- Secondary Outcome Measures
Name Time Method 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) 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)
Trial Locations
- Locations (9)
St. Martin De Porres Hospital
🇨🇳Chiayi City, Taiwan
E-DA Hospital
🇨🇳Kaohsiung City, Taiwan
Chia-Yi Christian Hospital
🇨🇳Chiayi City, Taiwan
Kaohsiung Medical University Hospital
🇨🇳Kaohsiung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
New Zealand Clinical Research (NZCR)
🇳🇿Auckland, New Zealand
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung City, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan City, Taiwan
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
🇨🇳Taoyuan City, Taiwan