Chronic Hepatitis B (CHB)
Conditions
Interventions
Conventional Hepatitis B Vaccine Group:Conventional Hepatitis B Vaccine Vaccination
Novel Dual-Adjuvant Hepatitis B Vaccine Group:Dual-Adjuvant Hepatitis B Vaccine Vaccination
Control Group:No Intervention
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Patients with chronic hepatitis B who achieved HBsAg clearance (<0.05 IU/mL) following Peg-IFN therapy. 2.Adults aged 18–70 years (inclusive), regardless of sex. 3.No evidence of cirrhosis on imaging at the time of enrollment. 4.Able to understand and voluntarily provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with compensated or decompensated hepatitis B-related cirrhosis, including those with a documented history of cirrhosis (based on imaging or histological evidence) prior to nucleos(t)ide analogue (NUC) therapy, a Child-Pugh score >= 5, or a history of decompensating events such as ascites, hepatic encephalopathy, or gastroesophageal variceal bleeding; 2. Patients with co-infection with HAV, HCV, HDV, HEV, or HIV, or with other chronic liver diseases, including alcoholic liver disease, inherited metabolic liver disease, drug-induced liver injury, and nonalcoholic fatty liver disease (NAFLD); 3. Patients with autoimmune diseases, including autoimmune liver diseases, psoriasis, and other autoimmune disorders; 4. Patients with primary hepatocellular carcinoma (HCC), or those with a serum alpha-fetoprotein (AFP) level > 100 ng/mL at screening accompanied by imaging findings suggestive of a malignant hepatic lesion, or with persistent AFP levels > 100 ng/mL for more than 3 months; 5. Patients with a neutrophil count < 1.5 x 10^9/L or a platelet count < 90 x 10^9/L; 6. Patients who are concurrently participating in another clinical trial; 7. Patients whom the investigator considers unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained HBsAg Negativity Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Viral recurrence rate;Other serological markers of hepatitis B;Anti-HBs seroconversion rate and antibody titer; | — |
Countries
China
Contacts
Public ContactLi Fahong
Huashan Hospital, Fudan University
Outcome results
None listed