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

NCT03674125 | Completed Phase 1 DMC

• 1 other identifier: HCV-003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

HCV Infection

Keywords

Hepatitis C Virus; HCV; Vaccine; DNA

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events

  Day0 through up to 28 weeks

• Administration (injection) site reactions

  Day0 through up to 28 weeks

• Changes in safety laboratory parameters described by frequency and severity grade

  Day0 through up to 28 weeks

Secondary Outcomes (2)

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

  Day0 through up to 28 weeks

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

  Day0 through up to 28 weeks

Study Arms (4)

Group 1

EXPERIMENTAL

GLS-6150 at 2.0 mg DNA/dose (3 dose prime plus boost)

Biological: GLS-6150

Group 2

EXPERIMENTAL

GLS-6150 at 1.0 mg DNA/dose (3 dose prime plus boost)

Biological: GLS-6150

Group 3

EXPERIMENTAL

GLS-6150 at 2.0 mg DNA/dose(3 dose prime plus boost)

Biological: GLS-6150

Group 4

EXPERIMENTAL

GLS-6150 at 2.0 mg DNA/dose(2 dose prime plus boost)

Biological: GLS-6150

Interventions

GLS-6150 BIOLOGICAL

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)

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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).

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• GeneOne Life Science, Inc.: lead
• Inovio Pharmaceuticals: collaborator

Study Sites (2)

Pusan National University Hospital

Busan, South Korea

Location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 17, 2018
• Study Start: September 4, 2018
• Primary Completion: April 7, 2020
• Study Completion: May 4, 2020
• Last Updated: May 27, 2020

Record last verified: 2020-05

Locations

KR (2)