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

Exclusion Criteria

• •Subjects who meet any of the followings cannot participate in this study.
• •1. Liver transplant recipients
• •2. Patients having decompensated liver cirrhosis with any history or evidence of ascites, esophageal variceal hemorrhage and/or hepatic encephalopathy
• •3. Malignant tumor patients who received radiotherapy or chemotherapy before study participation
• •4. Current active infection except hepatitis C that requires medical treatment
• •5. Autoimmune disease patients or immunodeficient (immuno-compromised) patients
• •6. Patients who received immunomodulators, cytotoxic agents or systemic corticosteroids for chronic disease other than hepatitis C within 2 months before study participation
• •7. Patients who received non-steroidal anti-inflammatory drugs (NSAIDs) within 10 days before IP administration
• •8. Concomitant diseases which is judged to be unacceptable for study participation by investigator (e.g., severe cardiovascular, renal , or psychiatric disease)
• •9. Clinically significant abnormal findings in physical examination,laboratory tests, vital signs or ECG at investigator's discretion
• •10. Patients with implantable pacemaker
• •11. Patients with metal implant in IP administration area or nearby
• •12. Positive for HBsAg, or HIV Ab
• •13. Previous history of gene therapy
• •14. History of allergy or anaphylaxis to any component of IP or other vaccine
• •15. Patients who received major surgery within 4 weeks before IP administration
• •16. Blood transfusion within 4 weeks before IP administration
• •17. Current alcohol or drug abuse
• •18. Patients who received other vaccine within 30 days before IP administration
• •19. Pregnancy or breast-feeding woman
• •20. Women of childbearing potential (WOCBP) or men with partner of WOCBP who are unwilling to use adequate contraception or be abstinent during the trial
• •21. Patients who received other investigational products within 30 days before study participation
• •22. Patients incapable of participating in this trial by investigator's judgment