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

Phase 2

Recruiting

• Conditions: chronic hepatitis B; D019694

• Registration Number: JPRN-jRCTs061210087
• Lead Sponsor: Hiasa Yoichi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion 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 severe heart failure by interview
Lung: SpO2 above 90% in room air

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
amount of HBsAg reduction<br>HBsAg loss (below 0.005 IU/mL by CLEIA) rate

Secondary Outcome Measures

Name	Time	Method
amount of HBV-DNA reduction<br>amount of HBcrAg reduction<br>HBeAg seroconversion rate<br>anti-HBs induction (more than 1.0 mIU/mL by CLEIA) rate<br>HBcAg specific CTL induction