*nih.life
			Clinical Trial Sponsors: GeneOne Life Science, Inc.

  Source:		NCT02670187


    		Phase I, Open Label Dose Ranging Safety
     		Study of GLS-5300 in Healthy Volunteers

			Completed

			First Update January 27, 2016
			Last Update January 8, 2019

			Brief Summary
			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.

			Detailed Description
			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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