The purpose of this study is to evaluate if the DNA vaccine CHRONVAC-C® intended for future treatment of Hepatitis C infections is safe and tolerated when administered to HCV infected individuals with a low viral load. In addition the capability of the vaccine to induce an immune response and the effect on viral load will be studied. In order to increase the uptake of the vaccine the intra muscular injection is combined with electroporation, meaning that a brief electric field is applied to the injection site resulting in temporary pores in the cell membranes that allows the vaccine to enter the cells.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
DNA vaccine, solution for injection, i.m. administration in combination with electroporation
I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge
Stockholm, Sweden
Department of Gastroenterology and Hepatology, Karolinska University Hospital, Solna
Stockholm, Sweden
To evaluate safety and tolerability of electroporation mediated i.m. delivery of CHRONVAC-C® in chronically HCV infected, treatment naive patients with low viral load.
Time frame: From start of treatment to 24 weeks post treatment
To provide information regarding dose related anti-viral immune response and dose related effect on viral load.
Time frame: From start of treatment to 24 weeks post treatment
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