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

Study Overview
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Brief Summary
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To evaluate the safety, tolerability and immunogenicity of VGX-6150 as second-line therapy in chronic hepatitis C patients

Official Title
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Multi-center, Open-label, Dose Escalation, Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of VGX-6150 for Second-line Therapy of Chronic Hepatitis C Infection

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Biological: VGX-6150


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: 1mg of DNA/dose<br>Subjects will receive a 3 dose series of VGX-6150 containing 1mg DNA/dose administered via IM injection + electroporation at Day 0, Week 4, Week 8, Week 12 | Biological: VGX-6150<br>* Plasmid DNA delivered via IM injection with electroporation<br>|
| Experimental: Experimental: 3mg of DNA/dose<br>Subjects will receive a 3 dose series of VGX-6150 containing 3mg DNA/dose administered via IM injection + electroporation at Day 0, Week 4, Week 8, Week 12 | Biological: VGX-6150<br>* Plasmid DNA delivered via IM injection with electroporation<br>|
| Experimental: Experimental: 6mg of DNA/dose<br>Subjects will receive a 3 dose series of VGX-6150 containing 6mg DNA/dose administered via IM injection + electroporation at Day 0, Week 4, Week 8, Week 12 | Biological: VGX-6150<br>* Plasmid DNA delivered via IM injection with electroporation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability | To evaluate the safety and tolerability of VGX-6150 as second-line therapy in chronic hepatitis C patients. | Screening   week 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity and virologic response | To evaluate the immunogenicity and virologic response to VGX-6150 in treatment failure patients with chronic hepatitis C | Screening   Week 36 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic hepatitis C, DNA Vaccine, Electroporation, Intramuscular (IM) Injection