Clinical trial retreatment by therapeutic vaccine against HBV

JRCT ID: jRCTs061200009

Registered date:10/07/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic hepatitis B
• Date of first enrollment: 20/07/2020
• Target sample size: 70
• Study type: Interventional
• Intervention(s): NASVAC (HBsAg 80 microgram, HBcAg 80microgram) will be given every 2 weeks for 10 times via nasal route to HBV carrier (HBV asymptomatic carrier and CHB patient treating with NAs)

Outcome(s)

• Primary Outcome: Reduction of HBsAg

Secondary Outcome

Incidence of AEs according to CTCAE grade especially for higher than grade 3
HBV-DNA reduction, HBsAg and HBcAg specific adoptive immunity, HBeAg seroconversion, resolution of liver fibrosis

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

HBV asymptomatic carrier or chronic hepatitis B patients under nucleotide analogue treatment those who previously perticipated in phase I/II clinical trial of therapeutic vaccine
(1) Positive for HBsAg or HBV-DNA with previous history of perticipation of phase I/II clinical trial of NASVAC
(2) Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
(3) No evidence of organ dysfunction
Liver: Child-Pugh Score under 9
Kidney: eGFR more than 30ml/min
Heart: No abnormality in ECG
Lung: SpO2 more than 90% in room air

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, interferons prior 90 days
(8) Inappropriate to participate in this trial

Related Information

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