New injection aims to tame chronic hepatitis b
NCT ID NCT07673068
First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time
Summary
This early-stage trial tests an injection called TVAX-028 in adults with chronic hepatitis B. The study checks if the drug is safe and how the body processes it. Participants receive either TVAX-028 with an adjuvant or the adjuvant alone, at different dose levels. The goal is to gather initial safety data before larger studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TVAX-028 injection (with adjuvant)
- What this could lead to
- If safe and effective, this could lead to a new treatment option for chronic hepatitis B, potentially helping control the virus long-term.
- What could go wrong
- This is an early Phase 1 trial with only 32 participants, focused on safety. It is too soon to know if TVAX-028 will work, 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
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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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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2027
An estimate. End dates often move.
- 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
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18 to 65 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\. Subjects voluntarily sign the informed consent, fully understand the study content, and are willing and able to comply with all trial procedures. * 2\. Male or female, aged 18 to 65 years. * 3\. Has a clinical diagnosis of chronic hepatitis B virus infection based on protocol-defined criteria. * 4\. Is receiving stable antiviral treatment with a single nucleos(t)ide analogue before enrollment. Has adequately suppressed HBV DNA and acceptable liver function based on protocol-defined criteria before the first administration of adjuvant or TVAX-028. * 5\. Has HBeAg-negative chronic hepatitis B virus infection based on protocol-defined criteria. * 6\. Has hepatitis B surface antigen (HBsAg) levels within the protocol-defined range before the first administration of adjuvant or TVAX-028. * 7\. Has no evidence of autoimmune liver disease based on protocol-defined testing and investigator assessment. * 8\. Participants of childbearing potential must agree to use effective contraception for the protocol-defined period. Exclusion Criteria: * 1\. Has liver disease other than chronic hepatitis B virus infection that may interfere with study participation or interpretation of study results * 2\. Has evidence or suspected evidence of hepatocellular carcinoma, cirrhosis, clinically significant hepatic space-occupying lesions, or clinically significant liver fibrosis based on imaging, laboratory testing, or non-invasive liver assessment. * 3\. Has clinically significant abnormalities in laboratory tests, including but not limited to liver function, renal function, hematology, coagulation, or electrolyte parameters, based on protocol-defined criteria. * 4\. Has received interferon or pegylated interferon treatment within the protocol-defined period before the first administration of adjuvant or TVAX-028, or plans to receive such treatment during the study. * 5\. Has received immunosuppressive therapy within the protocol-defined period before the first administration of adjuvant or TVAX-028. * 6\. Has received corticosteroid therapy within the protocol-defined period before the first administration of adjuvant or TVAX-028, except for permitted topical or inhaled corticosteroids. * 7\. Has clinically significant cardiovascular, renal, pancreatic, or other systemic disease that may increase study risk or interfere with study assessments. * 8\. Has inadequately controlled diabetes mellitus or hypertension based on protocol-defined criteria. * 9\. Has evidence of clinically significant co-infection, including hepatitis C virus, hepatitis D virus, human immunodeficiency virus, or active syphilis infection. * 10\. Has a history of malignancy within the protocol-defined period before the first administration of adjuvant or TVAX-028, except for conditions permitted by the protocol. * 11\. Has previously received organ transplantation. * 12\. Has a history of severe drug and food allergy, or is known to be allergic to any component of the investigational product or related products. * 13\. Has a history of drug abuse or clinically significant alcohol abuse within the protocol-defined period before the first dose. * 14\. Has a history or current diagnosis of psychiatric disease, severe depression, or other condition that may affect compliance with study procedures. * 15\. Has a history of severe allergy, or is known or suspected to be allergic to any component of the investigational product, adjuvant, or related products. * 16\. Has participated in another clinical trial of an investigational drug, biologic, medical device, or vaccine within the protocol-defined period before the first administration of adjuvant or TVAX-028. * 17\. Is pregnant or breastfeeding. * 18\. Is considered by the investigator to be unsuitable for participation in this study for any other reason.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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