Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02027116
Recruitment Status : Completed
First Posted : January 3, 2014
Last Update Posted : August 7, 2017
Sponsor:
Collaborator:
Inovio Pharmaceuticals
Information provided by (Responsible Party):
GeneOne Life Science, Inc.

Tracking Information
First Submitted Date  ICMJE January 1, 2014
First Posted Date  ICMJE January 3, 2014
Last Update Posted Date August 7, 2017
Study Start Date  ICMJE January 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 1, 2014)
Safety and Tolerability [ Time Frame: Screening ~ week 36 ]
To evaluate the safety and tolerability of VGX-6150 as second-line therapy in chronic hepatitis C patients.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 1, 2014)
Immunogenicity and virologic response [ Time Frame: Screening ~ Week 36 ]
To evaluate the immunogenicity and virologic response to VGX-6150 in treatment failure patients with chronic hepatitis C
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of VGX-6150 for Second-line Therapy of Chronic Hepatitis C Infection
Official Title  ICMJE 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
Brief Summary To evaluate the safety, tolerability and immunogenicity of VGX-6150 as second-line therapy in chronic hepatitis C patients
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C, Chronic
Intervention  ICMJE Biological: VGX-6150
Plasmid DNA delivered via IM injection with electroporation
Study Arms  ICMJE
  • 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
    Intervention: Biological: VGX-6150
  • 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
    Intervention: Biological: VGX-6150
  • 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
    Intervention: Biological: VGX-6150
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 1, 2014)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02027116
Other Study ID Numbers  ICMJE VGX-6150-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GeneOne Life Science, Inc.
Study Sponsor  ICMJE GeneOne Life Science, Inc.
Collaborators  ICMJE Inovio Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Sang Hoon Ahn, M.D, Ph.D. Severance Hospital
Principal Investigator: Jeong Heo, M.D, Ph.D. Pusan National University Hospital
PRS Account GeneOne Life Science, Inc.
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP