NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061200009

Registered date:10/07/2020

Clinical trial retreatment by therapeutic vaccine against HBV

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedChronic hepatitis B
Date of first enrollment01/07/2020
Target sample size70
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)NASVAC (HBsAg 80 microgram, HBcAg 80microgram) will be given every 2 weeks for 10 times via nasal route to HBV carrier (HBV asymptomatic carrier and CHB patient treating with NAs)

Outcome(s)

Primary OutcomeReduction of HBsAg
Secondary OutcomeIncidence of AEs according to CTCAE grade especially for higher than grade 3 HBV-DNA reduction, HBsAg and HBcAg specific adoptive immunity, HBeAg seroconversion, resolution of liver fibrosis

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 those who previously perticipated in phase I/II clinical trial of therapeutic vaccine (1) Positive for HBsAg or HBV-DNA with previous history of perticipation of phase I/II clinical trial of NASVAC (2) Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2 (3) No evidence of organ dysfunction Liver: Child-Pugh Score under 9 Kidney: eGFR more than 30ml/min Heart: No abnormality in ECG Lung: SpO2 more than 90% in room air
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, interferons prior 90 days (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