Hepatitis C, Chronic
Conditions
Keywords
chronic hepatitis C, DNA Vaccine, Electroporation, Intramuscular (IM) Injection
Brief summary
To evaluate the safety, tolerability and immunogenicity of VGX-6150 as second-line therapy in chronic hepatitis C patients
Interventions
BIOLOGICALVGX-6150
Plasmid DNA delivered via IM injection with electroporation
Sponsors
Inovio Pharmaceuticals
GeneOne Life Science, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who want to participate in this trial should meet all of the following criteria. 1. Male or females aged 19 to 65 years 2. Chronic hepatitis C patients infected with HCV genotype 1a or 1b 3. 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 4. Patients whose deltoid muscles (left or right) are accessible by 12 to 19 mm cannula/ electrode for intramuscular (IM) injection and electroporation (EP) 5. Patients who can comply with planned schedule of this protocol 6. Patients who give written informed consent voluntarily
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | Screening ~ week 36 | To evaluate the safety and tolerability of VGX-6150 as second-line therapy in chronic hepatitis C patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity and virologic response | Screening ~ Week 36 | To evaluate the immunogenicity and virologic response to VGX-6150 in treatment failure patients with chronic hepatitis C |
Countries
South Korea
Outcome results
None listed