NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061180100

Registered date:25/03/2019

Clinical trial for therapeutic vaccine against HBV

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedchronic hepatitis B
Date of first enrollment05/01/2017
Target sample size120
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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)

Outcome(s)

Primary OutcomeHBsAg reduction
Secondary OutcomeAnti-HBs induction, HBV-DNA reduction, HBeAg seroconversion

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 85age old
GenderBoth
Include criteriaHBV asymptomatic carrier or chronic hepatitis B patients under nucleotide analogue treatment after obtaining written informed concent (1) Positive for HBsAg or HBV-DNA (2) Eastern Cooperative Oncology Group (EOCG) Performance 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%
Exclude 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 disablitiy (6) Positive for HCV-RNA (7) Taking immunosuppresive drugs, steroid and interferons (8) Inappropriate to participate in this trial

Related Information

Contact

Public contact
Name Osamu Yoshihda
Address 454 Shitsukawa, Toon, Ehime Ehime Japan 791-0295
Telephone +81-89-960-5308
E-mail yoshidao@m.ehime-u.ac.jp
Affiliation Ehime University
Scientific contact
Name Yoichi Hiasa
Address 454 Shitsukawa, Toon, Ehime Ehime Japan 791-0295
Telephone +81-89-960-5308
E-mail hiasa@m.ehime-u.ac.jp
Affiliation Ehime University