Clinical trial for therapeutic vaccine against HBV
- Conditions
- chronic hepatitis B
- Registration Number
- JPRN-jRCTs061180100
- Lead Sponsor
- Hiasa Yoichi
- Brief Summary
CVP-NASVAC reduced HBsAg in chronic hepatitis B patients in both under NAs treatment and without NAs treatment. Furthermore, 4 patients lost HBsAg after CVP-NASVAC treatment. No severe AEs were observed by CVP-NASVAC treatment. CVP-NASVAC might be a new curable immune therapy against chronic HBV infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 71
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 <9
Kidney: eGFR >30 ml/min
Heart: No abnormality in ECG
Lung: Sp2 >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 HBsAg reduction
- Secondary Outcome Measures
Name Time Method Anti-HBs induction, HBV-DNA reduction, HBeAg seroconversion