This study evaluates the safety and immunogenicity of FP-02.2, a new therapeutic Hepatitis B vaccine, administered as an add-on therapy to entecavir or tenofovir.
This study evaluates the safety and immunogenicity of FP-02.2, a new therapeutic Hepatitis B vaccine, administered as an add-on therapy to entecavir or tenofovir. HBeAg-negative subjects will be randomized to receive low or high dose vaccine, in the presence or absence of IC31® adjuvant, or to receive placebo or IC31® adjuvant alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
61
Synthetic Peptide Hepatitis B Vaccine
Placebo
IC31® Adjuvant
Pusan National University Busan Hospital
Busan, South Korea
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Incidences of all TEAEs, IP related TEAEs, severe TEAEs, TEAEs leading to discontinuation of IP, and serious TEAEs,
Time frame: Throughout the study to Day 85
Number of Subjects With Local Injection Site Reactions
Incidence of local injection site reactions occurring up to 7 days after each injection
Time frame: Days 1 through 64
Immunological Response
IFN-gamma ELISpot assay specific for FP-02.2 peptides using cryopreserved PBMCs
Time frame: Change from baseline to Day 85
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