New vaccine combo aims to tame chronic hepatitis b
NCT ID NCT05770895
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-stage trial tested two experimental therapeutic vaccines, GS-2829 and GS-6779, in 83 healthy people and those with chronic hepatitis B. The main goal was to check safety and tolerability, while also measuring immune responses. The vaccines are designed to help the body fight the hepatitis B virus, potentially offering a new way to control the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GS-2829 and GS-6779 (therapeutic vaccines)
- What this could lead to
- If successful, this could point toward a new treatment option that helps control chronic hepatitis B without lifelong medication.
- What could go wrong
- This is an early Phase 1 trial focused on safety, so it is too soon to know if the vaccines will work. The study is small and may not show strong enough immune responses.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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83 people
The number who actually took part.
- Started
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Apr 2023
- Finished
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Jan 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
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Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan City, 33305, Taiwan
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Chia-Yi Christian Hospital
Chiayi City, 60002, Taiwan
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E-DA Hospital
Kaohsiung City, 82445, Taiwan
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Kaohsiung Medical University Hospital
Kaohsiung City, 807, Taiwan
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National Cheng Kung University Hospital
Tainan, 7428, Taiwan
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National Taiwan University Hospital
Taipei, 100229, Taiwan
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New Zealand Clinical Research (NZCR)
Auckland, 1010, New Zealand
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St. Martin De Porres Hospital
Chiayi City, 600, Taiwan
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Other studies related to the condition(s) this trial covers.
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