GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein.
GLS-5300 is indicated to prevent Middle East Respiratory Syndrome Coronavirus (MERS).
GLS-5300 is administered intramuscularly using the CELLECTRA® delivery device.
Clinical Trial NCT03721718: Evaluate the Safety, Tolerability and Immunogenicity Study of GLS-5300 in Healthy Volunteers
- 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.
Clinical Trial NCT02670187: Phase I, Open-Label Dose-Ranging Safety Study of GLS-5300 in Healthy Volunteers
- 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.