WGc0201 mRNA vaccine for people with chronic hepatitis B

An Open-Label, Single-Arm, Dose-Escalation Phase I Clinical Trial to Evaluate the Efficacy and Safety of WGc0201 in Patients With Chronic Hepatitis B Virus Infection

This Phase I trial will test whether the WGc0201 mRNA vaccine is safe and can lower viral markers in adults with stable chronic hepatitis B who are on antiviral therapy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT07051187 on ClinicalTrials.gov

What this trial studies

This is an open-label, single-arm, dose-escalation Phase I trial of WGc0201, an mRNA vaccine encoding the HBx antigen, in adults with chronic hepatitis B who have achieved virological stability on nucleoside analog therapy. The study enrolls three sequential dose groups with three patients per group to explore tolerability and safety. The primary objective is to observe and document the incidence and severity of adverse events following vaccination. Secondary observations will look for early signals of antiviral effect such as reductions in HBV DNA and HBsAg levels.

Who should consider this trial

Good fit: Adults aged 18–65 with chronic hepatitis B (HBsAg positive >6 months), on regular nucleoside analog therapy, with HBV DNA <100 IU/ml and HBsAg <1500 IU/ml, BMI 18–32 kg/m2, and without cirrhosis or major liver dysfunction are the intended participants.

Not a fit: Patients with advanced fibrosis or cirrhosis, active co-infections (e.g., HIV or HDV), significantly abnormal liver tests, or very high viral/antigen levels are unlikely to benefit from this early-phase vaccine trial.

Why it matters

Potential benefit: If successful, the vaccine could help the immune system clear HBV and potentially achieve functional cure defined by sustained HBV DNA negativity and HBsAg loss.

How similar studies have performed: Therapeutic hepatitis B vaccines to date have had mixed clinical results, and mRNA-based HBV vaccines are largely preclinical or early-stage with promising laboratory data but limited human data so far.

Eligibility criteria

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.

Where this trial is running

Chengdu, Sichuan

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Hong-Shuai Li, Dr

Conditions Chronic Hepatitis B Virus; mRNA; vaccine; chronic Hepatitis B virus