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

JRCT ID: jRCTs061210087

Registered date:22/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: chronic hepatitis B
• Date of first enrollment: 06/06/2022
• Target sample size: 200
• Study type: Interventional
• 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.

Outcome(s)

Primary Outcome

amount of HBsAg reduction
HBsAg loss (below 0.005 IU/mL by CLEIA) rate

Secondary Outcome

amount 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
• Gender: Both

Include criteria

HBV 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

• Primary Sponsor: Hiasa Yoichi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development