NIPH Clinical Trials Search

JRCT ID: jRCTs061210086

Registered date:22/03/2022

Clinical trial of therapeutic vaccine against chronic hepatitis B patients under NAs treatment

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedchronic hepatitis B
Date of first enrollment22/03/2022
Target sample size140
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) rate
Secondary Outcomeamount of HBV-DNA reduction amount of HBcrAg reduction HBeAg seroconversion rate anti-HBs induction (more than 1.0 mIU/mL) rate HBcAg specific CTL induction

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 85age old
Include criteriaChronic hepatitis B patients who fulfill the inclusion criteria below (1) 20-85 years old (2) Positive fo HBsAg or HBV-DNA (3) Taking nucleos(t)ide analogue (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 criteria1) 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) 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 +81-899605308
Affiliation Ehime University