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;
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);
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.
Alanine aminotransferase >3x ULN;
Internationally standardized ratio > 1.5;
Single group
WGc0201
DrugWgc0201 will be administered by intramuscular route, with a total of 9 doses.
Adverse events (AEs)
CATAE 5.0 standard
Immunogenicity of the vaccine (HBV-specific T-cell response)
ELISpot test
changes in virological indicators (HBV DNA/RNA)
qPCR、RT-qPCR
changes in virological indicators (HBsAg)
CLIA/ECLIA
changes in virological indicators (ALT normalization rate)
Kinetic (Rate) Assay
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