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| Name | Class |
|---|---|
| Inovio Pharmaceuticals | INDUSTRY |
| Walter Reed Army Institute of Research (WRAIR) | FED |
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The Middle East Respiratory Syndrome Coronavirus (MERS CoV), a virus related to Severe Acute respiratory syndrome coronavirus (SARS CoV), was first recognized as a cause of severe pulmonary infection in 2012. Infection with MERS CoV has been diagnosed in more than 1600 individuals with a mortality rate between 35% and 40%. GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein. This study will evaluate the safety of GLS-5300 at one of three dose levels following a three-injection vaccination regimen followed by electroporation. The study will also assess immune responses over a 1 year period with respect to the generation of antibody and cellular responses.
GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein. Following administration of the vaccine, a specialized medical device, CELLECTRA®, will deliver brief electrical pulses in a process known as electroporation (EP), to help move DNA into cells more efficiently.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLS-5300 | Experimental | GLS-5300 at 0.67 mg DNA/dose |
|
| GLS-5300 at 2 mg DNA/dose | Experimental | GLS-5300 at 2 mg DNA/dose |
|
| GLS-5300 at 6 mg DNA/dose | Experimental | GLS-5300 at 6 mg DNA/dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLS-5300 | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in safety laboratory measures | Day0 through Week 60 | |
| Incidence of solicited adverse events after vaccination | Day0 through Week 60 | |
| Incidence of unsolicited adverse events after vaccination | Day0 through Week 60 | |
| Incidence of serious adverse events | Day0 through Week 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Binding antibody response to S protein | Day0 through Week 60 following the first dose | |
| Neutralizing antibody response to S protein | Day0 through Week 60 following the first dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kayvon Modjarrad, MD, PhD | Walter Reed Army Institute of Research (WRAIR) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Institute of Research | Silver Spring | Maryland | 20910 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31351922 | Derived | Modjarrad K, Roberts CC, Mills KT, Castellano AR, Paolino K, Muthumani K, Reuschel EL, Robb ML, Racine T, Oh MD, Lamarre C, Zaidi FI, Boyer J, Kudchodkar SB, Jeong M, Darden JM, Park YK, Scott PT, Remigio C, Parikh AP, Wise MC, Patel A, Duperret EK, Kim KY, Choi H, White S, Bagarazzi M, May JM, Kane D, Lee H, Kobinger G, Michael NL, Weiner DB, Thomas SJ, Maslow JN. Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial. Lancet Infect Dis. 2019 Sep;19(9):1013-1022. doi: 10.1016/S1473-3099(19)30266-X. Epub 2019 Jul 24. |
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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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| T cell response |
| Day 0 through Week 60 following the first dose |
| D007239 |
| Infections |