chronic hepatitis B
Conditions
Interventions
NASVAC (HBsAg 80 microgram, HBcAg 80 microgram) given every 2 weeks for 10 times via nasal route to HBV carrier (HBV asymptomatic carrier and CHB patient treating with NUCs)
Sponsors
Hiasa Yoichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: HBV asymptomatic carrier or chronic hepatitis B patients under nucleotide analogue treatment after obtaining written informed consent (1) Positive for HBsAg or HBV-DNA (2) Eastern Cooperative Oncology Group (EOCG) Perforrmance Status (PS) 0-2 (3) No evidence of organ dysfunction Liver: Child Pugh Score 30 ml/min Heart: No abnormality in ECG Lung: Sp2 >92%
Exclusion criteria
Exclusion criteria: (1) Allergic history against past vaccination (2) Pregnant, unwilling to practice contraception during the study or lactating female (3) Severe complication (malignant hypertension, severe congestive heart failure, severe liver failure, poorly controlled diabetes mellitus, severe pulmonary fibrosis, active interstitial pneumonia) (4) Bearing malignant carcinoma including HCC (5) Severe mental disability (6) Positive for HCV-RNA (7) Taking immunosuppressive drugs, steroid and interferons (8) Inappropriate to participate in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg reduction | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti-HBs induction, HBV-DNA reduction, HBeAg seroconversion | — |
Contacts
Public ContactOsamu Yoshihda
Ehime University
Outcome results
None listed