Chronic Hepatitis BPhase 1NCT05770895
Study of HBV Therapeutic Vaccines GS-2829 and GS-6779 in Healthy Participants and Participants With Chronic Hepatitis B
A Phase 1 study testing GS-2829 and GS-6779 in people with Chronic Hepatitis B, run by Gilead Sciences at 9 sites in 2 countries.
Trial summary
The goal of this clinical study is to learn more about GS-2829 and GS-6779 in healthy participants and participants with CHB. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- GS-2829 and GS-6779
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 3 Apr 2023to 15 Jan 2025
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 electrocardiogram (ECG).
- Phase 1a (Healthy Individuals) only:
- Aged 18 through 60 years.
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- 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.
Who cannot join
- 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 (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.
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- 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.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Taiwan8 sites
Chia-Yi Christian Hospital
Chiayi City, 60002
St. Martin De Porres Hospital
Chiayi City, 600
Kaohsiung Medical University Hospital
Kaohsiung City, 807
E-DA Hospital
Kaohsiung City, 82445
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
National Cheng Kung University Hospital
Tainan, 7428
National Taiwan University Hospital
Taipei, 100229
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan City, 33305
About this study
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)
The goal of this clinical study is to learn more about GS-2829 and GS-6779 in healthy participants and participants with CHB.
- Conditions
- Chronic Hepatitis B
- Being tested
- GS-2829, GS-6779, Placebo
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-2829Biological
Administered intramuscularly
GS-6779Biological
Administered intramuscularly
PlaceboBiological
Administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a : Cohort 1 (Healthy Participants) : GS-2829 Low Dose (2 injections) | Experimental | 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. Receives: Biological: GS-2829; Biological: Placebo |
| Phase 1a : Cohort 2 (Healthy Participants) : GS-6779 Low Dose (2 injections) | Experimental | 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. Receives: Biological: GS-6779; Biological: Placebo |
| Phase 1a : Cohort 3 (Healthy Participants) : GS-2829 and GS-6779 Low Dose (2 cycles) | Experimental | 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. Receives: Biological: GS-2829; Biological: GS-6779; Biological: Placebo |
| Phase 1a : Cohort 4 (Healthy Participants) : GS-2829 and GS-6779 High Dose (2 cycles) | Experimental | 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. Receives: Biological: GS-2829; Biological: GS-6779; Biological: Placebo |
| Phase 1a : Cohort 8 (Healthy Participants) : GS-2829 and GS-6779 High Dose (3 cycles) | Experimental | 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. Receives: Biological: GS-2829; Biological: GS-6779; Biological: Placebo |
| Phase 1b : Cohort 5 (VS Participants with CHB) : GS-2829 and GS-6779 Low Dose (2 cycles) | Experimental | 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. Receives: Biological: GS-2829; Biological: GS-6779; Biological: Placebo |
| Phase 1b : Cohort 6 (VS Participants with CHB) : GS-2829 and GS-6779 High Dose (2 cycles) | Experimental | 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. Receives: Biological: GS-2829; Biological: GS-6779; Biological: Placebo |
| Phase 1b : Cohort 7 (VS Participants with CHB) : GS-2829 and GS-6779 High Dose (3 cycles) | Experimental | 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. Receives: Biological: GS-2829; Biological: GS-6779; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-emergent adverse events (TEAEs) were defined as any AE with a start date on or after the study drug start date; or any AE that led to premature discontinuation of study drug. An SAE is defined as an event that, at any dose, results in the following: Death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or a medically important event or reaction.
Measured: First dose date to end of study (followed up to 24 weeks post last dose (up to Day 225 [cohorts 1, 2], Day 253 [cohorts 3, 4, 5, 6], and Day 309 [cohorts 7 and 8])
Percentage of Participants With Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any time postbaseline. If the relevant baseline laboratory value is missing, any abnormality of at least Grade 1 observed postbaseline will be considered treatment emergent.
Measured: First dose date to end of study (followed up to 24 weeks post last dose (up to Day 225 [cohorts 1, 2], Day 253 [cohorts 3, 4, 5, 6], and Day 309 [cohorts 7 and 8])
Secondary outcomes (2)
Percentage of Participants With ≥ 3-Fold Increase in Vaccine-Induced Hepatitis B Virus (HBV) Specific T-Cell Responses
Vaccine-induced HBV-specific T cell responses were measured using an interferon-gamma (IFN-γ), enzyme-linked immunospot (ELISpot) assay with a readout of spot forming cells (SFCs) /10^6 peripheral blood mononuclear cells (PBMCs). Total response was the sum of the dimethylsulfoxide (DMSO) -adjusted averages for the 4 HBV peptides (HBV core + HBV polymerase (pol) A + HBV pol B + HBV surface antigen (sAg)). Response was defined as a ≥ 3-fold increase over baseline in vaccine-induced HBV-specific total T cell response (measured using the IFN-γ ELISpot assay). A participant's highest fold-increase postbaseline was utilized for analysis of responder/non-responder. Participants with missing values for fold change over baseline were counted as failures (missing = failure).
Measured: Up to 24 weeks post last dose (up to Day 225 [cohorts 1, 2]) or up to 12 weeks post last dose (up to Day 169 [cohorts 3, 4, 5, 6]; Day 225 [cohorts 7 and 8])
Mean Peak Levels of Vaccine-Induced HBV Specific T-Cell Responses
Vaccine-induced HBV-specific T cell responses were measured using an IFN-γ ELISpot assay with a readout of SFCs/10^6 PBMCs. Total response was the sum of the DMSO-adjusted averages for the 4 HBV peptides (HBV Core + HBV Pol A + HBV Pol B + HBV sAg). Peak values were the highest posttreatment value for an individual participant and then means were calculated across the participants in a cohort.
Measured: Up to 24 weeks post last dose (up to Day 225 [cohorts 1, 2]) or up to 12 weeks post last dose (up to Day 169 [cohorts 3, 4, 5, 6]; Day 225 [cohorts 7 and 8])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start3 Apr 2023
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770895
- Sponsor's protocol ID
- GS-US-642-5670
- Status last verified
- Jan 2026
- First submitted
- 1 Mar 2023
- Last updated
- 23 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.