Can a vaccine teach the immune system to fight hepatitis b?
NCT ID NCT06070051
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This early-stage trial tests an experimental vaccine called VRON-0200 in adults with chronic hepatitis B who are already taking antiviral medication. The vaccine aims to boost the body's immune response against the virus. Some participants also receive two additional drugs, elebsiran and tobevibart, to see if combining them improves the effect. The study focuses on safety and whether the vaccine can stimulate a strong T-cell response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- VRON-0200, a therapeutic vaccine using two chimpanzee adenovirus vectors, sometimes combined with the drugs elebsiran (VIR-2218) and tobevibart (VIR-3434)
- What this could lead to
- If successful, this approach could help the immune system control chronic hepatitis B, potentially allowing some people to stop long-term antiviral medication.
- What could go wrong
- This is an early, small trial focused on safety and immune response, so it may not lead to a functional cure. The vaccine and drug combination could also cause side effects.
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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35 people
The number who actually took part.
- Started
-
Sep 2023
- Finished
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Mar 2026
- 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 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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.
Inclusion Criteria: 1. Documented chronic HBV infection (eg, HBsAg+ ≥ 6 months with detectable HBsAg at screening) 2. Receipt of either entecavir, tenofovir (tenofovir alafenamide fumarate or tenofovir disoproxil fumarate), or lamivudine for at least 12 months before screening with no reported antiviral resistance during this time; still on treatment at screening and expected to stay on therapy during the study period 3. Virally suppressed for \> 12 months (HBV DNA \< 40 IU/mL) 4. No clinical diagnosis of advanced liver fibrosis and/or cirrhosis Exclusion Criteria: 1. History of hepatic decompensation, advanced fibrosis, or liver transplantation 2. History of hepatocellular carcinoma 3. History of risk factors for thrombosis and thrombocytopenia 4. Documented hepatitis A, hepatitis C, hepatitis D, hepatitis E, or HIV (or history of prior active disease) 5. Pregnant, nursing, or planning a pregnancy during the trial
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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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Aotearoa Clinical Trials, Middlemore Hospital
Auckland, New Zealand
-
Auckland City Hospital
Auckland, New Zealand
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Chinese University of Hong Kong
Hong Kong, Hong Kong
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Safety and efficacy of sequential treatment with a PD-1 antibody and pegylated interferon-α in Nucleos(t)Ide Analogue-Suppressed patients with chronic hepatitis b
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- CRISPR 'Brake Release' may reawaken immune cells to beat hepatitis b
- Could a simple scan and blood test outsmart liver cancer?
- Can a new injection tame chronic hepatitis b?