Study of HBV Therapeutic Vaccines GS-2829 and GS-6779 in Healthy Participants and Participants With Chronic Hepatitis B
NCT ID: NCT05770895
Last Updated: 2026-01-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
83 participants
INTERVENTIONAL
2023-04-03
2025-01-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Phase 1a : Cohort 1 (Healthy Participants) : GS-2829 Low Dose (2 injections)
Healthy participants will receive a single low dose of GS-2829 (≥ 0.5 x 10\^6 focus-forming unit (FFU)/mL) or placebo as intramuscular (IM) injection on Days 1 and 57.
GS-2829
Administered intramuscularly
Placebo
Administered intramuscularly
Phase 1a : Cohort 2 (Healthy Participants) : GS-6779 Low Dose (2 injections)
Healthy participants will receive a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL) or placebo as IM injection on Days 1 and 57.
GS-6779
Administered intramuscularly
Placebo
Administered intramuscularly
Phase 1a : Cohort 3 (Healthy Participants) : GS-2829 and GS-6779 Low Dose (2 cycles)
Healthy participants will receive a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) or placebo as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL) or placebo as IM injection, on Days 29 and 85.
GS-2829
Administered intramuscularly
GS-6779
Administered intramuscularly
Placebo
Administered intramuscularly
Phase 1a : Cohort 4 (Healthy Participants) : GS-2829 and GS-6779 High Dose (2 cycles)
Healthy participants will receive a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) or placebo as IM injection, on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) or placebo as IM injection, on Days 29 and 85.
GS-2829
Administered intramuscularly
GS-6779
Administered intramuscularly
Placebo
Administered intramuscularly
Phase 1a : Cohort 8 (Healthy Participants) : GS-2829 and GS-6779 High Dose (3 cycles)
Healthy participants will receive a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) or placebo as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) or placebo as IM injection on Days 29, 85 and 141.
GS-2829
Administered intramuscularly
GS-6779
Administered intramuscularly
Placebo
Administered intramuscularly
Phase 1b : Cohort 5 (VS Participants with CHB) : GS-2829 and GS-6779 Low Dose (2 cycles)
Virally suppressed (VS) participants with Chronic Hepatitis B (CHB) will receive a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) or placebo as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL) or placebo as IM injection on Days 29 and 85.
GS-2829
Administered intramuscularly
GS-6779
Administered intramuscularly
Placebo
Administered intramuscularly
Phase 1b : Cohort 6 (VS Participants with CHB) : GS-2829 and GS-6779 High Dose (2 cycles)
VS participants with CHB will receive a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) or placebo as IM injection on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) or placebo as IM injection on Days 29 and 85.
GS-2829
Administered intramuscularly
GS-6779
Administered intramuscularly
Placebo
Administered intramuscularly
Phase 1b : Cohort 7 (VS Participants with CHB) : GS-2829 and GS-6779 High Dose (3 cycles)
VS participants with CHB will receive a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) or placebo as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) or placebo as IM injection on Days 29, 85 and 141.
GS-2829
Administered intramuscularly
GS-6779
Administered intramuscularly
Placebo
Administered intramuscularly
Interventions
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GS-2829
Administered intramuscularly
GS-6779
Administered intramuscularly
Placebo
Administered intramuscularly
Eligibility Criteria
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Inclusion Criteria
* 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 electrocardiogram (ECG).
Phase 1a (Healthy Individuals) only:
* Aged 18 through 60 years.
* No prior history of Hepatitis B infection with a negative hepatitis B surface antigen (HBsAg) and Hepatitis B (HBV) core antibody.
Phase 1b (Virally Suppressed chronic hepatitis B (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 kilo pascal (kPa) within 6 months of screening).
* Diagnosed with CHB on suppressive oral antiviral for ≥ 6 months.
* Must have received an approved HBV-active oral antiviral agent for ≥ 6 months prior to screening with HBV DNA below lower limit of quantification (LLOQ) for ≥ 3 months prior to screening and with no plan to stop HBV-active antivirals during the study.
Exclusion Criteria
* 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 (SARs) coronavirus (COV) - 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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New Zealand Clinical Research (NZCR)
Auckland, , New Zealand
Chia-Yi Christian Hospital
Chiayi City, , Taiwan
St. Martin De Porres Hospital
Chiayi City, , Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
E-DA Hospital
Kaohsiung City, , Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan, , Taiwan
Countries
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References
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Gane E J et al. Safety, tolerability and immunogenicity of GS-2829 and GS-6779, a novel arenaviral vectored therapeutic hepatitis B vaccine: results from a phase 1a study in healthy participants. Poster THU-246. Presented at European Association for the Study of the Liver (EASL), 07-10 May 2025, Amsterdam, The Netherlands. J Hepatol 2025;82(S1):S831.
Gane E J, et al. Safety, tolerability, immunogenicity, and antiviral efficacy of GS-2829 and GS-6779, a novel, arenaviral-vectored, therapeutic hepatitis B vaccine: Results from a phase 1b study in virally suppressed patients with chronic hepatitis B. *Hepatology*. 2025;72(Suppl 1):197. Presented at: AASLD The Liver Meeting; November 7-11, 2025; San Diego, CA.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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GS-US-642-5670
Identifier Type: -
Identifier Source: org_study_id
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