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Phase I/II clinical trial for therapeutic HB vaccine containing HBsAg and HBcAg

Not Applicable
Conditions
Chronic hepatitis B
Registration Number
JPRN-UMIN000027442
Lead Sponsor
Ehime University Graduate School of Medicine
Brief Summary

The safety of HBsAg/HBcAg containing nasal administrative therapeutic vaccine. Anti-HBs induction and HBsAg reduction were confirmed after administration of the therapeutic vaccine.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
71
Inclusion Criteria

Not provided

Exclusion Criteria

severe complication malignancy taking immunosuppresive agents

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Safety: frequency and degree of adverse events
Secondary Outcome Measures
NameTimeMethod
Efficacy: HBV-DNA reduction
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