Clinical trial of HB vaccine against HBV infectio
- Conditions
- HBV infection
- Registration Number
- JPRN-jRCTs061180101
- Lead Sponsor
- Hiasa Yoichi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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 < 10mIU/mL after HB vaccination
(1) Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
(2) No evidence of organ dysfunction
Liver: Child-Pugh Score < 9
Kidney: eGFR > 30ml/min
Heart: No abnormality in ECG
Lung: SpO2 >92%
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anti-HBs induction
- Secondary Outcome Measures
Name Time Method Anti-HBc and HBcAg specific CTL induction