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| Name | Class |
|---|---|
| Inovio Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | GLS-6150 at 2.0 mg DNA/dose (3 dose prime plus boost) |
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| Group 2 | Experimental | GLS-6150 at 1.0 mg DNA/dose (3 dose prime plus boost) |
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| Group 3 | Experimental | GLS-6150 at 2.0 mg DNA/dose(3 dose prime plus boost) |
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| Group 4 | Experimental | GLS-6150 at 2.0 mg DNA/dose(2 dose prime plus boost) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Hospital | Busan | South Korea | ||||
| Yonsei University Health System, Severance Hospital |
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|
| Day0 through up to 28 weeks |
| Seoul |
| South Korea |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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