A Phase 1 interventional study of GLS-6150 in HCV Infection, sponsored by GeneOne Life Science, Inc.. Completed at 2 sites in Korea, Republic of. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-27.
Sponsored by GeneOne Life Science, Inc. · Phase 1, Interventional, and Prevention
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 32 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →GeneOne Life Science, Inc. is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Exclusion Criteria:
GLS-6150 at 2.0 mg DNA/dose (3 dose prime plus boost)
Biological: GLS-6150
GLS-6150 at 1.0 mg DNA/dose (3 dose prime plus boost)
Biological: GLS-6150
GLS-6150 at 2.0 mg DNA/dose(3 dose prime plus boost)
Biological: GLS-6150
GLS-6150 at 2.0 mg DNA/dose(2 dose prime plus boost)
Biological: GLS-6150
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)
Incidence of adverse events
Time frame: Day0 through up to 28 weeks
Administration (injection) site reactions
Time frame: Day0 through up to 28 weeks
Changes in safety laboratory parameters described by frequency and severity grade
Time frame: Day0 through up to 28 weeks
Antigen specific cellular immune responses to Hepatitis C virus as determined by Interferon-gamma (IFN-γ) ELISpot and/or FACS assay
Time frame: Day0 through up to 28 weeks
Binding antibody titers to the HCV non-structural proteins (NS3, NS4, NS5) measured by ELISA
Time frame: Day0 through up to 28 weeks
Plan to share: Undecided
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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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GeneOne Life Science, Inc.