Chronic hepatitis B
Conditions
Interventions
NASVAC (HBsAg 80 microgram, HBcAg 80microgram) will be given every 2 weeks for 10 times via nasal route to HBV carrier (HBV asymptomatic carrier and CHB patient treating with NAs)
Sponsors
Hiasa Yoichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: HBV asymptomatic carrier or chronic hepatitis B patients under nucleotide analogue treatment those who previously participated in phase I/II clinical trial of therapeutic vaccine (1) Positive for HBsAg or HBV-DNA with previous history of perticipation of phase I/II clinical trial of NASVAC (2) Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2 (3) No evidence of organ dysfunction Liver: Child-Pugh Score under 9 Kidney: eGFR more than 30ml/min Heart: No abnormality in ECG Lung: SpO2 more than 90% in room air
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, interferons prior 90 days (8) Inappropriate to participate in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of HBsAg | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of AEs according to CTCAE grade especially for higher than grade 3 HBV-DNA reduction, HBsAg and HBcAg specific adoptive immunity, HBeAg seroconversion, resolution of liver fibrosis | — |
Contacts
Public ContactOsamu Yoshida
Ehime University
Outcome results
None listed