NIPH Clinical Trials Search

JRCT ID: jRCTs061210087

Registered date:22/03/2022

Clinical trial of therapeutic vaccine against HBV carriers without anti-HBV treatment

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedchronic hepatitis B
Date of first enrollment06/06/2022
Target sample size200
Countries of recruitment
Study typeInterventional
Intervention(s)Participants will be assigned to CVP-NASVAC group or placebo group. CVP-NASVAC or placebo will be given total 10 doses every 2 weeks.


Primary Outcomeamount of HBsAg reduction HBsAg loss (below 0.005 IU/mL by CLEIA) rate
Secondary Outcomeamount of HBV-DNA reduction amount of HBcrAg reduction HBeAg seroconversion rate anti-HBs induction (more than 1.0 mIU/mL by CLEIA) rate HBcAg specific CTL induction

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 85age old
Include criteriaHBV carriers who fulfill the inclusion criteria below (1) 20-85 years old (2) Positive for HBsAg or HBV-DNA (3) Not under nucleos(t)ide analogue or interferon treatment (4) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS: 0-2) (5) No evidence of organ dysfunction Liver: Child-Pugh Score less than 9 Kidney: eGFR more than 30 Heart: No abnormality in ECG Lung: SpO2 above 90% in room air
Exclude criteria(1) Allergic history of 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, interferon prior 90 days (8) Taking nucleos(t)ide analogues (9) Inappropriate to participate in this trial

Related Information


Public contact
Name Osamu Yoshida
Address 454 Shitsukawa, Toon, Ehime Ehime Japan 791-0295
Telephone +81-89-960-5308
Affiliation Ehime University
Scientific contact
Name Yoichi Hiasa
Address 454 Shitsukawa, Toon, Ehime Ehime Japan 791-0295
Telephone +81-89-960-5308
Affiliation Ehime University