A Trial to Evaluate the Efficacy and Safety of WGc0201 in Patients With Chronic Hepatitis B Virus Infection (WGc0201-HBV)

April 1, 2026 updated by: Jiyan Liu

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

Existing nucleoside analogues (NAs) and interferon therapy for chronic hepatitis B (CHB) have limitations, including drug resistance, low HBsAg clearance rates, and irreversible immunosuppression. Therapeutic vaccines, by activating virus-specific T cells and B cells, hold promise for achieving functional cure (HBsAg clearance + sustained HBV DNA negativity). This study is an open-label, single-arm, dose-escalation Phase I clinical trial. The study population consists of patients with chronic hepatitis B virus infection who have achieved virological stability following standard antiviral therapy. Phase I (dose exploration): three dose groups, with three patients per group. The primary objective is to observe and evaluate the safety of the WGc0201 vaccine in the study population (incidence and severity of adverse events).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Although current antiviral treatments have achieved some clinical efficacy, there is still a lack of treatments that can truly cure hepatitis B, especially those that can completely eliminate HBsAg and prevent viral recurrence. Therapeutic hepatitis B vaccines are considered a potential treatment option for chronic hepatitis B and drug-resistant hepatitis B patients in the future. The development goal of therapeutic vaccines is to activate the body's specific immune response, promote the immune system to recognize and eliminate the hepatitis B virus, thereby achieving virological clearance and functional cure. WGc-0201 injection is an mRNA vaccine encoding the HBV-positive tumor antigen HBx. Preliminary basic research conducted by the team suggests that this vaccine has excellent safety, not only effectively clearing HBV DNA but also reducing HBsAg levels in serum and liver tissue while enhancing the expansion of specific T lymphocytes in the body. Therefore, we believe that the efficacy and safety of WGc0201 in treating hepatitis B warrant further investigation. We aim to use this Phase I study to preliminarily explore the therapeutic efficacy and safety of WGc0201 in this population and lay the groundwork for future clinical trials.

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WGc0201
Wgc0201 will be administered by intramuscular route, with a total of 9 doses
Drug: WGc0201
Wgc0201 will be administered by intramuscular route, with a total of 9 doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AEs)
Time Frame: 12 weeks
CATAE 5.0 standard
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity of the vaccine (HBV-specific T-cell response)
Time Frame: 12 weeks
ELISpot test
12 weeks
changes in virological indicators (HBV DNA/RNA)
Time Frame: 12 weeks
qPCR、RT-qPCR
12 weeks
changes in virological indicators (HBsAg)
Time Frame: 12 weeks
CLIA/ECLIA
12 weeks
changes in virological indicators (ALT normalization rate)
Time Frame: 12 weeks
Kinetic (Rate) Assay
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiyan Liu

Collaborators

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

May 30, 2025

First Submitted That Met QC Criteria

June 26, 2025

First Posted (Actual)

July 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WGc0201-HBV-001
  • 274953 (Registry Identifier: Chinese Clinical Trial Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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