Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of VGX-6150 for Second-line Therapy of Chronic Hepatitis C Infection

Inclusion criteria

• Subjects who want to participate in this trial should meet all of the following criteria.

• Male or females aged 19 to 65 years
• Chronic hepatitis C patients infected with HCV genotype 1a or 1b
• Patients who failed* SOC therapy with PEG-IFN and ribavirin or triple therapy with SOC and DAA agents

*Treatment failure is defined by any of the following; A. Partial response (PR) Serum HCV RNA level declined by at least 2 log10 but still detected at treatment week 24 B. Non-response (NR) Serum HCV RNA level not declined by at least 2 log10 at treatment week 12 C. Relapse Serum HCV RNA undetected during treatment but detectable after end of treatment D. Treatment discontinuation due to ADR or other reason

• Patients whose deltoid muscles (left or right) are accessible by 12 to 19 mm cannula/ electrode for intramuscular (IM) injection and electroporation (EP)
• Patients who can comply with planned schedule of this protocol
• Patients who give written informed consent voluntarily

Exclusion criteria

• Subjects who meet any of the followings cannot participate in this study.

• Liver transplant recipients
• Patients having decompensated liver cirrhosis with any history or evidence of ascites, esophageal variceal hemorrhage and/or hepatic encephalopathy
• Malignant tumor patients who received radiotherapy or chemotherapy before study participation
• Current active infection except hepatitis C that requires medical treatment
• Autoimmune disease patients or immunodeficient (immuno-compromised) patients
• Patients who received immunomodulators, cytotoxic agents or systemic corticosteroids for chronic disease other than hepatitis C within 2 months before study participation
• Patients who received non-steroidal anti-inflammatory drugs (NSAIDs) within 10 days before IP administration
• Concomitant diseases which is judged to be unacceptable for study participation by investigator (e.g., severe cardiovascular, renal , or psychiatric disease)
• Clinically significant abnormal findings in physical examination,laboratory tests, vital signs or ECG at investigator's discretion
• Patients with implantable pacemaker
• Patients with metal implant in IP administration area or nearby
• Positive for HBsAg, or HIV Ab
• Previous history of gene therapy
• History of allergy or anaphylaxis to any component of IP or other vaccine
• Patients who received major surgery within 4 weeks before IP administration
• Blood transfusion within 4 weeks before IP administration
• Current alcohol or drug abuse
• Patients who received other vaccine within 30 days before IP administration
• Pregnancy or breast-feeding woman
• Women of childbearing potential (WOCBP) or men with partner of WOCBP who are unwilling to use adequate contraception or be abstinent during the trial
• Patients who received other investigational products within 30 days before study participation
• Patients incapable of participating in this trial by investigator's judgment