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NCT05770895CompletedPhase 1

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

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)

Source: ClinicalTrials.gov · Last updated 23 Jan 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
83 (actual)
First submitted
1 Mar 2023
Start date
3 Apr 2023
Primary completion date
15 Jan 2025
Lead sponsor
Gilead Sciences
Diseases
Hepatitis B
NCT number
NCT05770895

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 83
  • From 3 Apr 2023 to the primary completion date, 15 Jan 2025
  • 9 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).
  • 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.

Other illness

  • Receipt of any HBV vaccine within 12 months of screening visit or planning HBV vaccination during the study period.

Lab values

  • Positive serum pregnancy test at screening or positive urine pregnancy on Day 1.

Other

  • Phase 1a and 1b:
  • Use of any systemic antibiotics within 30 days of screening.
  • Receipt of immunoglobulin or other blood products within 3 months of screening.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
New Zealand Clinical Research (NZCR)
Coordinator of this site? Confirm its status
AucklandNew ZealandUnknown status
Chia-Yi Christian Hospital
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Chiayi CityTaiwanUnknown status
St. Martin De Porres Hospital
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Chiayi CityTaiwanUnknown status
E-DA Hospital
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Kaohsiung CityTaiwanUnknown status
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanUnknown status
Kaohsiung Medical University Hospital
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanUnknown status
National Cheng Kung University Hospital
Coordinator of this site? Confirm its status
TainanTaiwanUnknown status
National Taiwan University Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Coordinator of this site? Confirm its status
Taoyuan CityTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.