New vaccine aims to cure chronic hepatitis b in early trial
NCT ID NCT07051187
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This early-stage trial tests a new vaccine called WGc0201 in 9 adults with chronic hepatitis B who are already on standard antiviral therapy. The vaccine is designed to boost the immune system to clear the virus, potentially leading to a functional cure. The main goal is to check safety, but researchers will also look at immune response and virus levels.
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 9 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2031
An estimate. End dates often move.
- Lead sponsor
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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
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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. Adult males or females aged ≥18 to ≤65 years; 2. 18≤ BMI ≤32 kg/m2; 3. Diagnosis of chronic hepatitis B infection (HBsAg positive for more than 6 months and detectable at screening); 4. Received only nucleoside (acid) analog therapy in the 12 months prior to screening and are still taking it regularly; 5. HBV-DNA viral load below 100 IU/ml; 6. HBsAg \<1500 IU/ml. Exclusion Criteria: 1. Includes HIV, co-infection with HDV, and liver biopsy suggestive of cirrhosis or advanced fibrosis within 6 months prior to screening (Metavir activity level A3 and stages F3 and F4; Ishak stages 4-6); 2. If no liver biopsy was documented, a Fibroscan screen result \>9 kPa (or equivalent) or a FibroTest screen result \>0.48 and an APRI (Aspartate Aminotransferase to Platelet Ratio Index) \>1 within ≤6 months of screening. 3. Alanine aminotransferase \>3x ULN; 4. Internationally standardized ratio \> 1.5; 5. Albumin \<3.5 g/dl; 6. Direct bilirubin \> 1.5x ULN; 7. Platelet count \<100,000/μl; 8. History of hepatic failure (e.g., ascites, encephalopathy, or variceal bleeding) or prior hepatocellular carcinoma; 9. Diseases or past history of the following systems or serious illnesses that the investigator considers inappropriate for participation in this trial, such as: cardiovascular system: unstable or significant cardiovascular disease, such as angina pectoris, recent episode of myocardial infarction, congestive heart failure, severe hypertension, significant arrhythmia or ECG abnormality, etc.; respiratory system: bronchiectasis, bronchial asthma, chronic obstructive pulmonary disease, respiratory failure, etc.; endocrine and metabolic diseases: diabetes mellitus, thyroid disease poorly controlled by medication, etc.; others: autoimmune diseases, active tuberculosis, malignant diseases (e.g., tumors), history of neurological or psychiatric disorders, etc; 10. Subjects who have participated in any drug/device clinical study within 3 months prior to receiving the experimental drug. 11. History of organ transplantation (except corneal transplantation and hair transplantation). 12. Those with alcoholism (alcohol consumption for more than 5 years prior to the screening period, with alcohol content greater than 40g per day for men and 20g per day for women) or known drug dependence. 13. Subjects who have a birth plan or a plan to donate sperm or eggs during the screening period, during the trial, and for 6 months after the end of the trial or who are unwilling to use effective contraception.
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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West China Hospital of Sichuan University
RECRUITINGChengdu, Sichuan, 610041, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.