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Completed

NCT Number: NCT05770895

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

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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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Zealand Clinical Research (NZCR), Auckland, New Zealand

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GS-2829

Biological

Administered intramuscularly

GS-6779

Biological

Administered intramuscularly

Placebo

Biological

Administered intramuscularly

Primary outcomes

  1. Percentage of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: 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])

    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.

  2. Percentage of Participants With Treatment-Emergent Laboratory Abnormalities

    Time frame: 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])

    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.

Secondary outcomes

  1. Percentage of Participants With ≥ 3-Fold Increase in Vaccine-Induced Hepatitis B Virus (HBV) Specific T-Cell Responses

    Time frame: 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])

    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).

  2. Mean Peak Levels of Vaccine-Induced HBV Specific T-Cell Responses

    Time frame: 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])

    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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2023
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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