To explore the effect on early viral kinetics and viral load, and to determine safety, tolerability and anti-viral response for the plasmid DNA vaccine CHRONVAC-C administered i.m. in combination with electroporation followed by standard of care (SOC) in treatment naïve chronic HCV genotype 1 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
IMP: I.m. administration of 500 μg plasmid DNA vaccine CHRONVAC-C (solution for injection) administered i.m. in combination with electroporation using MedPulser® DDS on 2 occasions with 4 weeks in between followed by standard of care (SOC) initiation after 14 - 42 days. SOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of \< 75 kg and 1200 mg/day for subjects with a BW of \> 75 kg)
SOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of \< 75 kg and 1200 mg/day for subjects with a BW of \> 75 kg)
I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital
Huddinge, Sweden
RECRUITINGDivision of Infectious Diseases, Department of Clinical and experimental medicine, Faculty of Health Sciences, Linköping University, Department of Infectious Diseases, County Council of Östergötland
Linköping, Sweden
RECRUITINGEarly viral kinetics - Second phase slope of viral decline
Time frame: 0-4 weeks after SOC onset
Rapid Viral Response (RVR). Percent subjects reaching non-detectable level of HCV-RNA.
Time frame: 4 weeks after SOC onset
Partial Early Viral Response (pEVR). Percent HCV-RNA positive subjects with more than 2 log 10 decline in HCV-RNA.
Time frame: 12 weeks after SOC onset
Complete Early Viral Response (cEVR). Percent subjects reaching non-detectable level of HCV-RNA.
Time frame: 12 weeks after SOC onset
Local tolerance
Local tolerance will be measured for subjects randomized to vaccination. Local tolerance will be measured 3 times during a time period of 2 h post vaccination. The site of injection will also be inspected at the following visits.
Time frame: up to 12 weeks after SOC onset
Change from baseline in vital signs
Time frame: 0 - 12 weeks
Number of patients with AEs
Time frame: 12 weeks
Change of blood status from baseline
Time frame: 0 - 12 weeks
Exploratory Analysis - Characterization and quantification of the vaccine primed NS3-immune response
Time frame: 0 - 12 weeks
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