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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
75
Walter Reed Institute of Research
Silver Spring, Maryland, United States
Mean change from baseline in safety laboratory measures
Time frame: Day0 through Week 60
Incidence of solicited adverse events after vaccination
Time frame: Day0 through Week 60
Incidence of unsolicited adverse events after vaccination
Time frame: Day0 through Week 60
Incidence of serious adverse events
Time frame: Day0 through Week 60
Binding antibody response to S protein
Time frame: Day0 through Week 60 following the first dose
Neutralizing antibody response to S protein
Time frame: Day0 through Week 60 following the first dose
T cell response
Time frame: Day 0 through Week 60 following the first dose
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