AzTrials
AzTrials

HCV InfectionPhase 1NCT03674125

Evaluation of Safety, Tolerability, and Immunogenicity Study of GLS-6150 in Healthy Volunteers and in Persons Previously Treated for Hepatitis C Virus Infection

A Phase 1 study testing GLS-6150 in people with HCV Infection, 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
Search all trials

Trial summary

Hepatitis C virus (HCV) is an enveloped, single strand, positive sense RNA flavivirus. Infection by HCV is typically chronic, although an estimated ~10-20% may spontaneously clear the virus. HCV affects between 1.3 - 2 billion individuals, or 2-3% of the global population. Read more about this study

Who is it for?
Ages 19 to 65 yearsHealthy volunteers can take part
Conditions the study is for
HCV Infection
What is being tested?
GLS-6150
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesSouth Korea
Study dates
4 Sep 2018to 4 May 2020
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 19-65 years;
  • HCV seronegative (Group 1 only), HCV seropositive (Groups 2, 3, 4 only)
  • Prior treatment for genotype 1a or 1b Hepatitis C infection with treatment ending (12 weeks after end of DAA treatment, 24 weeks after end of combination treatment with Ribavirin/Interferon) prior to study enrollment and with documented achievement of HCV viral clearance (multiple episodes of treatment for Hepatitis C are allowed, Groups 2, 3, 4 only)
  • Hepatitis C virus PCR negative at screen
  • Able to provide consent to participate and having signed an Informed Consent Form (ICF);
  • Able and willing to comply with all study procedures;
Show all 11Show fewer
  • Women of child-bearing potential agree to use medically effective contraception (oral contraception, barrier methods, spermicide, etc.) or have a partner who is sterile during this trial, or have a partner who is medically unable to induce pregnancy.
  • Normal screening ECG or screening ECG with no clinically significant findings;
  • Screening laboratory must be within normal limits or have only Grade 0-1 findings;
  • No history of clinically significant immunosuppressive or autoimmune disease.
  • Not currently or within the previous 4 weeks taking immunosuppressive agents (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or prednisone at a dose less than 10 mg/day, or a steroid equivalent).

Who cannot join

  • Administration of an investigational compound either currently or within 3 months of first dose;
  • Administration of any vaccine (excluding influenza vaccination) within 4 weeks of first dose;
  • Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose
  • Administration of any blood product within 3 months of first dose;
  • Pregnancy or breast feeding or plans to become pregnant during the course of the study;
  • History of positive serologic test for HIV, hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Principal Investigator or Medical Monitor;
Show all 24Show fewer
  • Positive Hepatitis C serology performed at baseline (Group 1 only)
  • Positive screening PCR test for hepatitis C virus;
  • History of HCV infection with other than genotype 1a or 1b (Group 2, 3 and 4 only)
  • Baseline evidence of kidney disease as measured by creatinine greater than 1.5 mg/dL
  • Baseline screening lab(s) with Grade 2 or higher abnormality;
  • Chronic liver disease, cirrhosis, hemochromatosis, Wilson's disease, alcoholic liver disease, autoimmune hepatitis, or α-1 antitrypsin deficiency(In case of cirrhosis, the person who has been judged F4 grade in Fibroscan);
  • Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation;
  • Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or prednisone at a dose equal to or greater than 10 mg/day, or steroid equivalent);
  • Current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept;
  • Prior major surgery or any radiation therapy within 4 weeks of the first vaccination;
  • Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome; history of PSVT syndrome, history of prolonged QT syndrome;
  • Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator (AICD)
  • Metal implants within 20 cm of the planned site(s) of injection;
  • Presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition at the planned site(s) of injection.
  • Prisoner or subjects who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness;
  • Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints; or
  • Not willing to allow storage and future use of samples for Hepatitis C virus related research
  • Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint.

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Pusan National University Hospital

    Busan

  • Yonsei University Health System, Severance Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Multi-center, Open-label, Dose-ranging, Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of GLS-6150, Administered ID and Followed by Cellectra® 2000 Healthy Adults and in Persons Previously Treated for Hepatitis C Virus Infection.

Hepatitis C virus (HCV) is an enveloped, single strand, positive sense RNA flavivirus. Infection by HCV is typically chronic, although an estimated ~10-20% may spontaneously clear the virus. HCV affects between 1.3 - 2 billion individuals, or 2-3% of the global population. HCV has a seroprevalence of approximately 1% in developed countries such as the US and Korea. Chronic HCV infection leads to hepatic fibrosis and cirrhosis. This Phase I study will evaluate the safety, tolerability and immunogenicity of GLS-6150 administered intradermally (ID) followed by electroporation at 1.0 mg and 2.0 mg/dose assessing 3 and 4-dose regimens.

Read the detailed description

HCV-003 will assess the safety and immunogenicity of GLS-6150 in those previously treated for HCV infection and who have achieved a sustained virologic response (SVR). This study will provide information as to whether GLS-6150 may be useful to prevent re-infection for those successfully cleared of HCV infection. GLS-6150 is a DNA plasmid vaccine that expresses the NS3/4A gene of HCV, NS4B gene of HCV, the NS5A gene of HCV and IL-28B. GLS-6150 will be administered at one of two dose levels (1 mg or 2 mg) and given as a 2 or 3 vaccination priming regimen with a boost vaccination given at 6 months. Immune T cell and serologic responses will be determined after each dose.

Conditions
HCV Infection
Being tested
GLS-6150
Keywords
Hepatitis C Virus, HCV, Vaccine, DNA
Medical subject headings
Hepatitis C

What participants receive

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

  • GLS-6150Biological

    Group 1: GLS-6150 2.0 mg at 0, 4, 12, and 24 weeks (N=8, healthy volunteers); Group 2: GLS-6150 1.0 mg at 0, 4, 12, and 24 weeks (N=8, previously treated for HCV infection); Group 3: GLS-6150 2.0 mg at 0, 4, 12, and 24 weeks (N=8, previously treated for HCV infection); Group 4: GLS-6150 2.0 mg at 0, 8, and 24 weeks (N=8, previously treated for HCV infection)

Study groups in NCT03674125
Study groupRoleWhat they receive
Group 1ExperimentalGLS-6150 at 2.0 mg DNA/dose (3 dose prime plus boost)
Receives: Biological: GLS-6150
Group 2ExperimentalGLS-6150 at 1.0 mg DNA/dose (3 dose prime plus boost)
Receives: Biological: GLS-6150
Group 3ExperimentalGLS-6150 at 2.0 mg DNA/dose(3 dose prime plus boost)
Receives: Biological: GLS-6150
Group 4ExperimentalGLS-6150 at 2.0 mg DNA/dose(2 dose prime plus boost)
Receives: Biological: GLS-6150

What is being measured

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

  1. Incidence of adverse events

    Measured: Day0 through up to 28 weeks

  2. Administration (injection) site reactions

    Measured: Day0 through up to 28 weeks

  3. Changes in safety laboratory parameters described by frequency and severity grade

    Measured: Day0 through up to 28 weeks

Secondary outcomes (2)

  1. Antigen specific cellular immune responses to Hepatitis C virus as determined by Interferon-gamma (IFN-γ) ELISpot and/or FACS assay

    Measured: Day0 through up to 28 weeks

  2. Binding antibody titers to the HCV non-structural proteins (NS3, NS4, NS5) measured by ELISA

    Measured: Day0 through up to 28 weeks

Timeline

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

  1. First posted17 Sep 2018
  2. Study start4 Sep 2018
  3. Primary completion7 Apr 2020
  4. Study completion4 May 2020

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03674125
Sponsor's protocol ID
HCV-003
Status last verified
May 2020
First submitted
14 Sep 2018
Last updated
27 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GLS-6150 in people with HCV Infection, 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 11 inclusion and 24 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 27 May 2020. 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?

Incidence of adverse events (time frame: Day0 through up to 28 weeks). The study lists 3 primary outcomes in all. 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 NCT03674125.

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 27 May 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in