Phase 1 N=83 Randomized Double-blind Treatment

Study of HBV Therapeutic Vaccines GS-2829 and GS-6779 in Healthy Participants and Participants With Chronic Hepatitis B

Chronic Hepatitis B

Bottom Line

View on ClinicalTrials.gov: NCT05770895 ↗

Enrolled (actual)

Serious AEs

1.2%

Results posted

Jan 2026

Primary outcome: Primary: Percentage of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 100.0; 100.0; 100.0; 100.0 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: GS-2829 (Biological); GS-6779 (Biological); Placebo (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Gilead Sciences
Primary completion: Jan 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	100.0; 100.0; 100.0; 100.0; 100.0; 90.0	—
PRIMARY Percentage of Participants With Treatment-Emergent Laboratory Abnormalities	100.0; 87.5; 100.0; 100.0; 88.9; 90.0	—
SECONDARY Percentage of Participants With ≥ 3-Fold Increase in Vaccine-Induced Hepatitis B Virus (HBV) Specific T-Cell Responses	12.5; 0.0; 87.5; 87.5; 100.0; 0.0	—
SECONDARY Mean Peak Levels of Vaccine-Induced HBV Specific T-Cell Responses	1154.0; 196.0; 1677.1; 2853.7; 3865.2; 283.6	—

Summary

The goal of this clinical study is to learn more about GS-2829 and GS-6779 in healthy participants and participants with CHB.

Eligibility Criteria

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 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.

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 (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.

Note - Other protocol defined Inclusion/Exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05770895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.