WGc0201 mRNA vaccine for people with chronic hepatitis B

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Hong-Shuai Li, Dr
• Email: lihongshuai456@163.com
• Phone: +86-18384262516

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.