NCT02670187

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

Phase I, Open-label, Dose Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of GLS-5300, Administered IM Followed by Electroporation in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: GeneOne Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	GLS-5300

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-05-01
• Completion: 2017-09-01
• First posted: 2016-02-01
• Last updated: 2019-01-09

Locations

1 site across 1 country: United States