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
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
1 other identifier
interventional
18
1 country
2
Brief Summary
To evaluate the safety, tolerability and immunogenicity of VGX-6150 as second-line therapy in chronic hepatitis C patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2014
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 1, 2014
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedFirst Posted
Study publicly available on registry
January 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedAugust 7, 2017
August 1, 2017
1.5 years
January 1, 2014
August 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Immunogenicity and virologic response
Screening ~ Week 36
Study Arms (3)
Experimental: 1mg of DNA/dose
EXPERIMENTALSubjects 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
Experimental: 3mg of DNA/dose
EXPERIMENTALSubjects 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
Experimental: 6mg of DNA/dose
EXPERIMENTALSubjects 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
Interventions
Plasmid DNA delivered via IM injection with electroporation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GeneOne Life Science, Inc.lead
- Inovio Pharmaceuticalscollaborator
Study Sites (2)
Pusan National University Hospital
Pusan, South Korea
Yonsei University Severance Hospital
Seoul, South Korea
Related Publications (1)
Han JW, Sung PS, Hong SH, Lee H, Koh JY, Lee H, White S, Maslow JN, Weiner DB, Park SH, Jeong M, Heo J, Ahn SH, Shin EC. IFNL3-adjuvanted HCV DNA vaccine reduces regulatory T cell frequency and increases virus-specific T cell responses. J Hepatol. 2020 Jul;73(1):72-83. doi: 10.1016/j.jhep.2020.02.009. Epub 2020 Feb 21.
PMID: 32088322DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang Hoon Ahn, M.D, Ph.D.
Severance Hospital
- PRINCIPAL INVESTIGATOR
Jeong Heo, M.D, Ph.D.
Pusan National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 1, 2014
First Posted
January 3, 2014
Study Start
January 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2017
Last Updated
August 7, 2017
Record last verified: 2017-08