This was an open-label study that evaluated the safety, tolerability, and immunogenicity of dose combinations of INO-1800 (DNA plasmids encoding Hepatitis B surface antigen \[HBsAg\] and Hepatitis B core antigen \[HBcAg\]) and INO-9112 (DNA plasmid encoding human interleukin 12) delivered by electroporation (EP) in 90 (ninety) nucleos(t)ide analogue treated participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Research and Education, Inc.
San Diego, California, United States
Safety Assessment (Composite of multiple measures: pain (VAS), adverse events, lab abnormalities, changes in vital signs)
Composite outcome measure consisting of multiple measures, including: 1. Local pain immediately after Study Treatment/EP and at select times using a visual analog scale (VAS) from 0 to 10, with 0 representing "No Pain" and 10 representing "Worst Pain" 2. Frequency and severity of local and systemic events for at least 7 days after Study Treatment/EP 3. Frequency and severity of laboratory abnormalities 4. Frequency and severity of all adverse events 5. Changes in vital signs
Time frame: Signing of ICF through up to 76 weeks following the first dose
Immunogenicity Assessment
Composite outcome measure consisting of multiple measures, including 1. Breadth and Magnitude of antigen specific cellular immune responses * Interferon-ɣ ELISpot * Flow Cytometry for T-cell activation, cytolytic phenotype, memory phenotype 2. Breadth and Magnitude of antigen specific ELISA
Time frame: Baseline (screening and first dose) and select points up to 76 weeks after the first dose
Viral/Antiviral Assessment
Composite outcome measure consisting of multiple measures, including: 1. Evaluate effect on HBsAg kinetics as measured in the quantitative HBsAg assay 2. Evaluate effect on maintenance of HBV DNA suppression (\< 90 IU/ml) as measured in the quantitative viral load assay
Time frame: Screening and/or first dose and select points up to 76 weeks after the first dose
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