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).
• Adult males or females aged ≥18 to ≤65 years;
• 18≤ BMI ≤32 kg/m2;
• Diagnosis of chronic hepatitis B infection (HBsAg positive for more than 6 months and detectable at screening);
• Received only nucleoside (acid) analog therapy in the 12 months prior to screening and are still taking it regularly;
• HBV-DNA viral load below 100 IU/ml;
• HBsAg \<1500 IU/ml.