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| Name | Class |
|---|---|
| Inovio Pharmaceuticals | INDUSTRY |
| International Vaccine Institute | OTHER |
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The Middle East Respiratory Syndrome Coronavirus (MERS CoV), is a cause of severe and highly fatal lower respiratory tract infection, first identified in 2012. As of August 2018, there have been 2229 cases reported with a case fatality rate >35%. In 2015 an individual returning to South Korea served as the index case for an outbreak of 186 individuals, of who, >20% died. GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein. This Phase I/IIa study will evaluate the safety, tolerability and immunogenicity of GLS-5300 administered intradermally (ID) followed by electroporation at 0.3 and 0.6 mg/dose assessing 2 and 3-dose regimens.
GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLS-5300 with ID Cellectra electroporation | Experimental | GLS-5300 at 0.3mg DNA/dose |
|
| GLS-5300 at 0.3mg DNA/dose with ID Cellectra electroporation | Experimental | GLS-5300 at 0.3mg DNA/dose |
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| GLS-5300 at 0.6mg DNA/dose (3 dose regimen) | Experimental | GLS-5300 at 0.6mg DNA/dose with ID Cellectra electroporation |
|
| GLS-5300 at 0.6mg DNA/dose (2 dose regimen) | Experimental | GLS-5300 at 0.6mg DNA/dose with ID Cellectra electroporation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLS-5300 | Biological | [Part A] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) [Part B] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) GLS-5300 0.6 mg at 0, 4, and 12 weeks (N=25) GLS-5300 0.6 mg at 0 and 8 weeks (N=25) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Incidence of Adverse events by System organ class (SOC); preferred term (PT); severity and relationship to study treatment and schedule | Day0 through up to 60 weeks |
| Administration (injection) site reactions | Administration (injection) site reactions described by frequency | Day0 through up to 60 weeks |
| Changes in safety laboratory parameters | Number of participants with changes based on frequency in safety lab parameters in Complete Blood Count and Liver panel tests" or similar. | Day0 through up to 60 weeks |
| Administration (injection) site pain | Administration (injection) site pain as described by Visual Analog Scale (VAS) | Administration (injection) site pain |
| Measure | Description | Time Frame |
|---|---|---|
| Cellular Immune Responses | Antigen specific cellular immune responses to MERS-CoV as determined by Interferon-gamma (IFN-γ) ELISpot | Day0 through up to 60 weeks |
| Binding antibody titers | Binding antibody titers against MERS-CoV for a 2 and 3 dose vaccination regimens |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Maslow, MD, PhD, MBA | GeneOne Life Science, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam | South Korea | ||||
| Seoul National University Hospital |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| Cellectra 2000 Electroporation | Device | GLS-5300 administered ID followed by Cellectra 2000 Electroporation |
|
| Day0 through up to 60 weeks |
| Neutralizing antibodies | Titers of neutralizing antibodies against MERS-CoV | Day0 through up to 60 weeks |
| Seoul |
| South Korea |
| D007239 |
| Infections |