HBV infection
Conditions
Interventions
NASVAC (HBsAG 80 microgram, HBcAg 80 microgram) given every 2 weeks for 3 times via nasal route to healthy individuals (HB vaccine naive, HB vaccine responder, HB vaccine non-responder). Additional 1
Sponsors
Hiasa Yoichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy individuals agreed to participate in this trial after obtaining writen informed consent a) HB vaccine naive: No pasthistory of HB vaccination b) HB vaccine responder: Anti-HBs > 10mIU/mL after HB vaccination c) HB vaccine non-responder: Anti-HBs 30ml/min Heart: No abnormality in ECG Lung: SpO2 >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 |
|---|---|
| Anti-HBs induction | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti-HBc and HBcAg specific CTL induction | — |
Contacts
Public ContactOsamu Yoshida
Ehime University
Outcome results
None listed