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)

This study is currently recruiting participants.
Verified January 2014 by VGX International, Inc.
Sponsor:
Collaborator:
Inovio Pharmaceuticals
Information provided by (Responsible Party):
VGX International, Inc.
ClinicalTrials.gov Identifier:
NCT02027116
First received: January 1, 2014
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Hepatitis C, Chronic
Biological: VGX-6150
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by VGX International, Inc.:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: Screening ~ week 36 ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of VGX-6150 as second-line therapy in chronic hepatitis C patients.


Secondary Outcome Measures:
  • Immunogenicity and virologic response [ Time Frame: Screening ~ Week 36 ] [ Designated as safety issue: No ]
    To evaluate the immunogenicity and virologic response to VGX-6150 in treatment failure patients with chronic hepatitis C


Estimated Enrollment: 18
Study Start Date: January 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental: 1mg of DNA/dose
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
Plasmid DNA delivered via IM injection with electroporation
Experimental: Experimental: 3mg of DNA/dose
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
Plasmid DNA delivered via IM injection with electroporation
Experimental: Experimental: 6mg of DNA/dose
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
Plasmid DNA delivered via IM injection with electroporation

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02027116

Contacts
Contact: Hyojin Lee +82-2-527-0610 hjlee@vgxi.com
Contact: Moonsup Jeong, Ph.D. +82-2-527-0617 msjeong@vgxi.com

Locations
Korea, Republic of
Pusan National University Hospital Recruiting
Pusan, Korea, Republic of
Contact: Sojeong Park       nayou007@nate.com   
Principal Investigator: Jeong Heo, M.D, Ph.D.         
Yonsei University Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Sun Im Yun       SIYUN104@yuhs.ac   
Principal Investigator: Sang Hoon Ahn, M.D, Ph.D.         
Sponsors and Collaborators
VGX International, Inc.
Inovio Pharmaceuticals
Investigators
Principal Investigator: Sang Hoon Ahn, M.D, Ph.D. Yonsei University Severance Hospital
Principal Investigator: Jeong Heo, M.D, Ph.D. Pusan National University Hospital
  More Information

No publications provided

Responsible Party: VGX International, Inc.
ClinicalTrials.gov Identifier: NCT02027116     History of Changes
Other Study ID Numbers: VGX-6150-01
Study First Received: January 1, 2014
Last Updated: January 16, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by VGX International, Inc.:
chronic hepatitis C
DNA Vaccine
Electroporation
Intramuscular (IM) Injection

Additional relevant MeSH terms:
Hepatitis C, Chronic
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 16, 2014