Clinical Trial Sponsors: GeneOne Life Science, Inc.
Source: NCT02670187⇦⇨ Phase I, Open Label Dose Ranging Safety
⇩ Study of GLS-5300 in Healthy Volunteers
First Update January 27, 2016
Last Update January 8, 2019
The Middle East Respiratory SyndromeCoronavirus (MERS CoV), a virus related to
Severe Acute respiratory syndrome coronavirus
(SARS CoV), was first recognized as a cause
of severe pulmonaryinfection 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.