Clinical trial of HB vaccine against HBV infection

JRCT ID: jRCTs061180101

Registered date:25/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: HBV infection
• Date of first enrollment: 05/01/2017
• Target sample size: 100
• Study type: Interventional
• Intervention(s): NASVAC (HBsAG 80 microgram, HBcAg 80 microgram) given every 2 weeks for 3 times via nasal route to healthy individuals (HB vaccine naive, HB vaccine responder, HB vaccine non-responder). Additional 1 dose will be administrated, if anti-HBs is under 10 mIU/mL at 28 week.

Outcome(s)

• Primary Outcome: Anti-HBs induction
• Secondary Outcome: Anti-HBc and HBcAg specific CTL induction

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

Healthy individuals agreed to participate in this trial after obtaining writen informed consent
a) HB vaccine naive: No pasthistory of HB vaccination
b) HB vaccine responder: Anti-HBs > 10mIU/mL after HB vaccination
c) HB vaccine non-responder: Anti-HBs < 10mIU/mL after HB vaccination
(1) Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
(2) No evidence of organ dysfunction
Liver: Child-Pugh Score < 9
Kidney: eGFR > 30ml/min
Heart: No abnormality in ECG
Lung: SpO2 >92%

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 and interferons
(8) Inappropriate to participate in this trial

Related Information

• Primary Sponsor: Hiasa Yoichi