A 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).

NCT Number	NCT07051187
Lead Sponsor	Jiyan Liu Collaborators: West China Hospital
Conditions	Chronic Hepatitis B Virus (Hbv)
Enrollment	9 participants
Start Date	2026-09-01
Primary Completion	2027-09-01 (estimated)
Study Completion	2031-09-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-01