NCT07051187

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Jiyan Liu · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

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.

Conditions

• Chronic Hepatitis B Virus (Hbv)

Interventions

Type	Name	Description
DRUG	WGc0201	Wgc0201 will be administered by intramuscular route, with a total of 9 doses.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-07-30
• Completion: 2027-07-30
• First posted: 2025-07-04
• Last updated: 2026-04-07

Locations

1 site across 1 country: China