Study of Therapeutic Vaccination With Intensified Schedule Plus Pegasys Dual Therapy on Chronic Hepatitis B Infection

Exclusion Criteria

• •1. Patients with decompensated liver cirrhosis, any one of the following ① Serum bilirubin \> 3 mg/dL
• •② Prothrombin time \> 6 seconds prolonged or INR \>2.3
• •③ Serum albumin \< 2.8 g/dL
• •④ History of ascites, variceal hemorrhage, or hepatic encephalopathy
• •⑤ Child-Pugh score ≥7 (Child-Pugh class B or C)
• •2. Patients who have evidence of renal insufficiency defined as serum creatinine\>1.5 mg/dL
• •3. Patients with psychological problem including depression
• •4. Patients who have previous/current significant co-morbidities including congestive heart failure, chronic kidney disease, hematologic disease and malignancy including hepatocellular carcinoma(patients with malignancy cured 5 years before screening can be enrolled)
• •5. Patients with seropositivity for anti-HCV, anti-HDV or anti-HIV
• •6. Patients who have excessive alcohol consumption (\> 30 g/day)
• •7. Patients who have evidence of autoimmune hepatitis, hemochromatosis or Wilson's disease
• •8. Pregnant or breast feeding females or plan for pregnancy or no contraception
• •9. Patients with disease may deteriorate with interferon therapy(eg, autoimmune thyroiditis)
• •10. Patients who have an psoriasis
• •11. Patients who have history of antiviral-resistant HBV after previous treatment with oral antiviral agents
• •12. Previous diagnosis with immunodeficiency or concomitant treatment of immune suppressive agent or previous organ transplantation Recipients
• •13. Patients who have a history of hypersensitivity to study drug
• •14. Uncontrollable seizure, convulsion and/or central nervous system disorders
• •15. Patients with severe bone marrow disorder or with history of hypersensitivity to biologic agent such as vaccine.
• •16. Neutrophil count \< 1,500/mm3 or platelet count \< 75,000/mm3 or hemoglobin \< 10 g/dl
• •17. Patients with Pulmonary disease (in case of history of pulmonary disease with complete recovery, enrollment is on investigator's discretion)
• •18. Patients who have a fever ≥ 38 °C at the baseline
• •19. Patients who have a risk of febrile response or systemic reaction
• •20. Patients who the investigator deems inappropriate to participate in this study