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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
\[Part A\] 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)
GLS-5300 administered ID followed by Cellectra 2000 Electroporation
Seoul National University Bundang Hospital
Seongnam, South Korea
Seoul National University Hospital
Seoul, South Korea
Incidence of adverse events
Incidence of Adverse events by System organ class (SOC); preferred term (PT); severity and relationship to study treatment and schedule
Time frame: Day0 through up to 60 weeks
Administration (injection) site reactions
Administration (injection) site reactions described by frequency
Time frame: 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.
Time frame: Day0 through up to 60 weeks
Administration (injection) site pain
Administration (injection) site pain as described by Visual Analog Scale (VAS)
Time frame: Administration (injection) site pain
Cellular Immune Responses
Antigen specific cellular immune responses to MERS-CoV as determined by Interferon-gamma (IFN-γ) ELISpot
Time frame: Day0 through up to 60 weeks
Binding antibody titers
Binding antibody titers against MERS-CoV for a 2 and 3 dose vaccination regimens
Time frame: Day0 through up to 60 weeks
Neutralizing antibodies
Titers of neutralizing antibodies against MERS-CoV
Time frame: Day0 through up to 60 weeks
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