NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061180101

Registered date:25/03/2019

Clinical trial of HB vaccine against HBV infection

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedHBV infection
Date of first enrollment05/01/2017
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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 dose will be administrated, if anti-HBs is under 10 mIU/mL at 28 week.

Outcome(s)

Primary OutcomeAnti-HBs induction
Secondary OutcomeAnti-HBc and HBcAg specific CTL induction

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 65age old
GenderBoth
Include criteriaHealthy 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%
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 disability (6) Positive for HCV-RNA (7) Taking immunosuppressive drugs, steroid and interferons (8) Inappropriate to participate in this trial

Related Information

Contact

Public contact
Name Osamu Yoshida
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