Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of VGX-6150 for Second-line Therapy of Chronic Hepatitis C Infection (VGX-6150-01)

GeneOne Life Science

Status and phase: Completed; Phase 1

Conditions: Hepatitis C, Chronic

Treatments: Biological: VGX-6150

Study type: Interventional

Funder types: Industry

Identifiers

NCT02027116

VGX-6150-01

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Experimental: 1mg of DNA/dose

Experimental group

Description:

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

Treatment:

Biological: VGX-6150

Experimental: 3mg of DNA/dose

Experimental group

Description:

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

Treatment:

Biological: VGX-6150

Experimental: 6mg of DNA/dose

Experimental group

Description:

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

Treatment:

Biological: VGX-6150