Could a vaccine tame chronic hepatitis b?
NCT ID NCT04843852
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study is testing whether HEPLISAV-B, a vaccine normally used to prevent hepatitis B, is safe for people who already have chronic hepatitis B. Ten adults on stable antiviral therapy will receive two vaccine shots and be monitored for side effects and immune responses over 14 months. The goal is to see if the vaccine can safely boost the body's fight against the virus.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HEPLISAV-B (hepatitis B vaccine with an adjuvant to boost immune response)
- What this could lead to
- If it works, this could point toward a way to help the immune system better control chronic hepatitis B, potentially reducing the need for lifelong medication.
- What could go wrong
- This is a very small, early-stage safety trial with only 10 participants. It is not designed to prove the vaccine works for treatment, and side effects are possible.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2025
- Expected to finish
-
Apr 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: In order to participate in this study, an individual must meet all the following criteria: 1. \>18 years old 2. Diagnosed with CHB infection, without HIV, hepatitis C nor hepatitis D co-infections 3. Currently receiving NUC with HBV VL \<100 IU/ml for ≥ 12 months 4. Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures. 5. Determined by medical history, targeted physical examination, and clinical judgement of the investigator to be in good health. CHB infection is defined as any individual with documentation of a positive HBsAg and/or detectable HBV DNA test for at least 6 months. Exclusion Criteria: A participant will be ineligible to participate on this study if any of the following criteria are met: 1. Pregnancy or breast feeding. 2. Received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to Screening (for corticosteroids ≥ 20 mg/day of prednisone equivalent). Received anti-CD20 immunosuppressant within 12 months of screening. Topical tacrolimus is allowed if not used within 14 days prior to Day 1. 3. Received or plans to receive live virus vaccines within 4 weeks, and inactivated vaccine within 2 weeks prior to randomization; or plans to receive a non-study vaccine within 28 days after any dose of study vaccine (with exception for seasonal influenza vaccine within 14 days of study vaccine). 4. Administration of any blood products within 3 months prior to randomization. 5. Participation in a study with an investigational study product or device within 30 days of randomization. 6. Has allergies to any hepatitis B and/or yeast-based vaccines. 7. Subjects meeting any of the following laboratory parameters at screening: 1. ALT greater than 3 times the upper limit of normal 2. Elevated total bilirubin WITH direct bilirubin greater than 2 times upper limit of normal 8. Is acutely ill or febrile 72 hours prior to or at vaccine dosing (fever defined as ≥ 38.0°C/100.4°F). Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. 9. Have any chronic or acute or unstable conditions that the investigator considers a contraindication to study participation.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic hepatitis B are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Institute of Human Virology, University of Maryland School of Medicine
RECRUITINGBaltimore, Maryland, 21201, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Massive Real-World database aims to map how chronic diseases interact
- Higher dose of hepatitis b drug put to the test in damaged livers
- Can a Two-Drug combo wipe out hepatitis b for good?
- One shot, six protections: could a single vaccine replace multiple infant shots?
- Can one shot replace six? a new vaccine aims to protect infants from six diseases at once
- Can a new pill push hepatitis b virus to undetectable levels?