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Hepatitis C, ChronicPhase 1VGX-6150-01NCT02027116

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

A Phase 1 study testing VGX-6150 in people with Hepatitis C, Chronic, run by GeneOne Life Science, Inc. at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 19 to 65 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
VGX-6150
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesSouth Korea
Study dates
Jan 2014to Jul 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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
  • Patients who received major surgery within 4 weeks before IP administration
  • Blood transfusion within 4 weeks before IP administration
  • Current alcohol or drug abuse
  • Patients who received other vaccine within 30 days before IP administration
  • Pregnancy or breast-feeding woman
  • Women of childbearing potential (WOCBP) or men with partner of WOCBP who are unwilling to use adequate contraception or be abstinent during the trial
  • Patients who received other investigational products within 30 days before study participation
  • Patients incapable of participating in this trial by investigator's judgment

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Pusan National University Hospital

    Pusan

  • Yonsei University Severance Hospital

    Seoul

Other trials in South Korea

About this study

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

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

Being tested
VGX-6150
Keywords
chronic hepatitis C, DNA Vaccine, Electroporation, Intramuscular (IM) Injection
Medical subject headings
Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VGX-6150Biological

    Plasmid DNA delivered via IM injection with electroporation

Study groups in NCT02027116
Study groupRoleWhat they receive
Experimental: 1mg of DNA/doseExperimentalSubjects 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
Receives: Biological: VGX-6150
Experimental: 3mg of DNA/doseExperimentalSubjects 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
Receives: Biological: VGX-6150
Experimental: 6mg of DNA/doseExperimentalSubjects 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
Receives: Biological: VGX-6150

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability

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

    Measured: Screening ~ week 36

Secondary outcomes (1)

  1. Immunogenicity and virologic response

    To evaluate the immunogenicity and virologic response to VGX-6150 in treatment failure patients with chronic hepatitis C

    Measured: Screening ~ Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionJul 2015
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02027116
Sponsor's protocol ID
VGX-6150-01
Acronym
VGX-6150-01
Status last verified
Aug 2017
First submitted
1 Jan 2014
Last updated
7 Aug 2017
Results posted
No
Data monitoring committee
No

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.

    PubMed 32088322

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VGX-6150 in people with Hepatitis C, Chronic, run by GeneOne Life Science, Inc. at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability (time frame: Screening ~ week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02027116, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2017.

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