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The goal of this clinical study is to learn more about GS-2829 and GS-6779 in healthy participants and participants with CHB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-2829 | Biological | Administered intramuscularly |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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]) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Key Inclusion Criteria:
Phase 1a and 1b:
Phase 1a (Healthy Individuals) only:
Phase 1b (Virally Suppressed chronic hepatitis B (CHB) Individuals)):
Key Exclusion Criteria:
Phase 1a and 1b:
Note - Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Zealand Clinical Research (NZCR) | Auckland | 1010 | New Zealand | |||
| Chia-Yi Christian Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| Background | 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. |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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148 participants (114 in Phase 1a and 34 in Phase 1b) were screened.
Participants were enrolled at study sites in New Zealand and Taiwan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1a : Cohort 1 (Healthy Participants) : GS-2829 Low Dose (2 Injections) | Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10^6 FFU/mL) as Intramuscular (IM) injection on Days 1 and 57. |
| FG001 | Phase 1a : Cohort 2 (Healthy Participants) : GS-6779 Low Dose (2 Injections) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 20, 2023 | Dec 19, 2025 |
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| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| GS-6779 | Biological | Administered intramuscularly |
|
| Placebo | Biological | Administered intramuscularly |
|
| 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. | 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]) |
| Chiayi City |
| 60002 |
| Taiwan |
| St. Martin De Porres Hospital | Chiayi City | 600 | Taiwan |
| Kaohsiung Medical University Hospital | Kaohsiung City | 807 | Taiwan |
| E-DA Hospital | Kaohsiung City | 82445 | Taiwan |
| Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 833 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 7428 | Taiwan |
| National Taiwan University Hospital | Taipei | 100229 | Taiwan |
| Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital | Taoyuan City | 33305 | Taiwan |
Healthy participants received a single low dose of GS-6779 (≥ 0.5 x 10^6 FFU/mL) as IM injection on Days 1 and 57. |
| FG002 | Phase 1a : Cohort 3 (Healthy Participants) : GS-2829 and GS-6779 Low Dose (2 Cycles) | Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10^6 FFU/mL) as IM injection on Days 29 and 85. |
| FG003 | Phase 1a : Cohort 4 (Healthy Participants) : GS-2829 and GS-6779 High Dose (2 Cycles) | Healthy participants received a single high dose of GS-2829 (0.5 mL of a undiluted ≥ 0.5 x 10^7 FFU/mL) as IM injection on Day 1 and Day 57; and single high dose of GS-6779 (0.5 ml of a undiluted ≥ 0.5 x 10^7 FFU/mL) as IM injection on Day 29 and Day 85. |
| FG004 | Phase 1a : Cohort 8 (Healthy Participants) : GS-2829 and GS-6779 High Dose (3 Cycles) | Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 29, 85 and 141. |
| FG005 | Phase 1a: Placebo : Healthy Participants | Healthy participants who received placebo pooled across Phase 1 a Cohorts 1-4 and 8 (2 participants per cohort were randomized to placebo). |
| FG006 | Phase 1b : Cohort 5 (VS Participants With CHB) : GS-2829 and GS-6779 Low Dose (2 Cycles) | VS participants with CHB received a single low dose of GS-2829 (≥ 0.5 x 10^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10^6 FFU/mL ) as IM injection on Days 29 and 85. |
| FG007 | Phase 1b : Cohort 6 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (2 Cycles) | VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 29 and 85. |
| FG008 | Phase 1b : Cohort 7 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (3 Cycles) | VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 29, 85 and 141. |
| FG009 | Phase 1b: Placebo : VS CHB Participants | VS CHB participants who received placebo pooled across Phase 1b Cohorts 5-7 (2 participants per cohort were randomized to placebo). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1a : Cohort 1 (Healthy Participants) : GS-2829 Low Dose (2 Injections) | Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10^6 FFU/mL) as Intramuscular (IM) injection on Days 1 and 57. |
| BG001 | Phase 1a : Cohort 2 (Healthy Participants) : GS-6779 Low Dose (2 Injections) | Healthy participants received a single low dose of GS-6779 (≥ 0.5 x 10^6 FFU/mL)] as IM injection on Days 1 and 57. |
| BG002 | Phase 1a : Cohort 3 (Healthy Participants) : GS-2829 and GS-6779 Low Dose (2 Cycles) | Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10^6 FFU/mL) as IM injection, on Days 29 and 85. |
| BG003 | Phase 1a : Cohort 4 (Healthy Participants) : GS-2829 and GS-6779 High Dose (2 Cycles) | Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection, on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection, on Days 29 and 85. |
| BG004 | Phase 1a : Cohort 8 (Healthy Participants) : GS-2829 and GS-6779 High Dose (3 Cycles) | Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 29, 85 and 141. |
| BG005 | Phase 1a: Placebo : Healthy Participants | Healthy participants who received placebo pooled across Phase 1 a Cohorts 1-4 and 8 (2 participants per cohort were randomized to placebo). |
| BG006 | Phase 1b : Cohort 5 (VS Participants With CHB) : GS-2829 and GS-6779 Low Dose (2 Cycles) | VS participants with CHB received a single low dose of GS-2829 (≥ 0.5 x 10^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10^6 FFU/mL ) as IM injection on Days 29 and 85. |
| BG007 | Phase 1b : Cohort 6 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (2 Cycles) | VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 29 and 85. |
| BG008 | Phase 1b : Cohort 7 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (3 Cycles) | VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 29, 85 and 141. |
| BG009 | Phase 1b: Placebo : VS CHB Participants | VS CHB participants who received placebo pooled across Phase 1b Cohorts 5-7 (2 participants per cohort were randomized to placebo). |
| BG010 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
| |||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | 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]) |
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| Primary | 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. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | 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]) |
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| Secondary | 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). | Participants in the Immunogenicity Analysis Set were analyzed. The Immunogenicity Analysis Set included all randomized participants who received at least 1 dose of study drug and have at least 1 value for HBV-specific T-cell total response using the interferon gamma (IFN-γ) enzyme-linked immunospot (EliSpot) assay after administration of the investigational product. | Posted | Number | percentage of participants | 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]) |
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| Secondary | 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. | Participants in the Immunogenicity Analysis Set were analyzed. | Posted | Mean | Standard Deviation | SFC/10^6 PBMCs | 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]) |
|
Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8
All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study).
AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1a : Cohort 1 (Healthy Participants) : GS-2829 Low Dose (2 Injections) | Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10^6 FFU/mL) as Intramuscular (IM) injection on Days 1 and 57. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG001 | Phase 1a : Cohort 2 (Healthy Participants) : GS-6779 Low Dose (2 Injections) | Healthy participants received a single low dose of GS-6779 (≥ 0.5 x 10^6 FFU/mL)] as IM injection on Days 1 and 57. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG002 | Phase 1a : Cohort 3 (Healthy Participants) : GS-2829 and GS-6779 Low Dose (2 Cycles) | Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10^6 FFU/mL) as IM injection, on Days 29 and 85. | 0 | 10 | 0 | 8 | 8 | 8 |
| EG003 | Phase 1a : Cohort 4 (Healthy Participants) : GS-2829 and GS-6779 High Dose (2 Cycles) | Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection, on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection, on Days 29 and 85. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG004 | Phase 1a : Cohort 8 (Healthy Participants) : GS-2829 and GS-6779 High Dose (3 Cycles) | Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 29, 85 and 141. | 0 | 9 | 1 | 9 | 9 | 9 |
| EG005 | Phase 1a: Placebo : Healthy Participants | Healthy participants who received placebo pooled across Phase 1 a Cohorts 1-4 and 8 (2 participants per cohort were randomized to placebo). | 0 | 10 | 0 | 10 | 9 | 10 |
| EG006 | Phase 1b : Cohort 5 (VS Participants With CHB) : GS-2829 and GS-6779 Low Dose (2 Cycles) | VS participants with CHB received a single low dose of GS-2829 (≥ 0.5 x 10^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10^6 FFU/mL ) as IM injection on Days 29 and 85. | 0 | 8 | 0 | 8 | 6 | 8 |
| EG007 | Phase 1b : Cohort 6 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (2 Cycles) | VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 29 and 85. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG008 | Phase 1b : Cohort 7 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (3 Cycles) | VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 29, 85 and 141. | 0 | 8 | 0 | 8 | 6 | 8 |
| EG009 | Phase 1b: Placebo : VS CHB Participants | VS CHB participants who received placebo pooled across Phase 1b Cohorts 5-7 (2 participants per cohort were randomized to placebo). | 0 | 6 | 0 | 6 | 3 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lisfranc fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tricuspid valve disease | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Conjunctival cyst | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Catheter site bruise | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Injection site discomfort | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Medical device pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vessel puncture site bruise | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chlamydial infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Lisfranc fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Temporomandibular pain and dysfunction syndrome | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Parosmia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dandruff | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA 27.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 4, 2025 | Dec 19, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Other or More Than One Race |
|
| Native Hawaiian or Other Pacific Islander |
|
| American Indian or Alaska Native |
|
| Taiwan |
|
| SAE |
|
| OG003 | Phase 1a : Cohort 4 (Healthy Participants) : GS-2829 and GS-6779 High Dose (2 Cycles) | Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection, on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection, on Days 29 and 85. |
| OG004 | Phase 1a : Cohort 8 (Healthy Participants) : GS-2829 and GS-6779 High Dose (3 Cycles) | Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 29, 85 and 141. |
| OG005 | Phase 1a: Placebo : Healthy Participants | Healthy participants who received placebo pooled across Phase 1 a Cohorts 1-4 and 8 (2 participants per cohort were randomized to placebo). |
| OG006 | Phase 1b : Cohort 5 (VS Participants With CHB) : GS-2829 and GS-6779 Low Dose (2 Cycles) | VS participants with CHB received a single low dose of GS-2829 (≥ 0.5 x 10^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10^6 FFU/mL ) as IM injection on Days 29 and 85. |
| OG007 | Phase 1b : Cohort 6 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (2 Cycles) | VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 29 and 85. |
| OG008 | Phase 1b : Cohort 7 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (3 Cycles) | VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 29, 85 and 141. |
| OG009 | Phase 1b: Placebo : VS CHB Participants | VS CHB participants who received placebo pooled across Phase 1b Cohorts 5-7 (2 participants per cohort were randomized to placebo). |
|
|
| OG001 | Phase 1a : Cohort 2 (Healthy Participants) : GS-6779 Low Dose (2 Injections) | Healthy participants received a single low dose of GS-6779 (≥ 0.5 x 10^6 FFU/mL)] as IM injection on Days 1 and 57. |
| OG002 | Phase 1a : Cohort 3 (Healthy Participants) : GS-2829 and GS-6779 Low Dose (2 Cycles) | Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10^6 FFU/mL) as IM injection, on Days 29 and 85. |
| OG003 | Phase 1a : Cohort 4 (Healthy Participants) : GS-2829 and GS-6779 High Dose (2 Cycles) | Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection, on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection, on Days 29 and 85. |
| OG004 | Phase 1a : Cohort 8 (Healthy Participants) : GS-2829 and GS-6779 High Dose (3 Cycles) | Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 29, 85 and 141. |
| OG005 | Phase 1a: Placebo : Healthy Participants | Healthy participants who received placebo pooled across Phase 1 a Cohorts 1-4 and 8 (2 participants per cohort were randomized to placebo). |
| OG006 | Phase 1b : Cohort 5 (VS Participants With CHB) : GS-2829 and GS-6779 Low Dose (2 Cycles) | VS participants with CHB received a single low dose of GS-2829 (≥ 0.5 x 10^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10^6 FFU/mL ) as IM injection on Days 29 and 85. |
| OG007 | Phase 1b : Cohort 6 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (2 Cycles) | VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 29 and 85. |
| OG008 | Phase 1b : Cohort 7 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (3 Cycles) | VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 29, 85 and 141. |
| OG009 | Phase 1b: Placebo : VS CHB Participants | VS CHB participants who received placebo pooled across Phase 1b Cohorts 5-7 (2 participants per cohort were randomized to placebo). |
|
|
Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10^6 FFU/mL) as IM injection, on Days 29 and 85. |
| OG003 | Phase 1a : Cohort 4 (Healthy Participants) : GS-2829 and GS-6779 High Dose (2 Cycles) | Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection, on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection, on Days 29 and 85. |
| OG004 | Phase 1a : Cohort 8 (Healthy Participants) : GS-2829 and GS-6779 High Dose (3 Cycles) | Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 29, 85 and 141. |
| OG005 | Phase 1a: Placebo : Healthy Participants | Healthy participants who received placebo pooled across Phase 1 a Cohorts 1-4 and 8 (2 participants per cohort were randomized to placebo). |
| OG006 | Phase 1b : Cohort 5 (VS Participants With CHB) : GS-2829 and GS-6779 Low Dose (2 Cycles) | VS participants with CHB received a single low dose of GS-2829 (≥ 0.5 x 10^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10^6 FFU/mL ) as IM injection on Days 29 and 85. |
| OG007 | Phase 1b : Cohort 6 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (2 Cycles) | VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 29 and 85. |
| OG008 | Phase 1b : Cohort 7 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (3 Cycles) | VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10^7 FFU/mL) as IM injection on Days 29, 85 and 141. |
| OG009 | Phase 1b: Placebo : VS CHB Participants | VS CHB participants who received placebo pooled across Phase 1b Cohorts 5-7 (2 participants per cohort were randomized to placebo). |
|
|