Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05770895 | Study of HBV Therapeutic Vaccines GS-2829 and GS-6779 in Healthy Participants and Participants With Chronic Hepatitis B | PHASE1 | COMPLETED | 83 | — | — | Apr 3, 2023 | Jan 15, 2025 | Jan 23, 2026 | 9 | New Zealand, Taiwan |
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| GS-2829 | BIOLOGICAL | Administered intramuscularly |
| GS-6779 | BIOLOGICAL | Administered intramuscularly |
| Placebo | BIOLOGICAL | Administered intramuscularly |
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 electrocardiogram (ECG). Phase 1a (Healthy Individuals) only: * Aged 18 through 60 years. * No prior history of...