NCT03721718

Evaluate the Safety, Tolerability and Immunogenicity Study of GLS-5300 in Healthy Volunteers

Phase I/IIa, Open-label, Dose Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of GLS-5300, Administered ID Followed by CELLECTRA® 2000 (Electroporation, EP)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: GeneOne Life Science, Inc. · Industry
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	GLS-5300	\[Part A\] 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)
DEVICE	Cellectra 2000 Electroporation	GLS-5300 administered ID followed by Cellectra 2000 Electroporation

Timeline

• Start date: 2018-08-28
• Primary completion: 2019-05-30
• Completion: 2020-04-22
• First posted: 2018-10-26
• Last updated: 2020-05-27

Locations

2 sites across 1 country: South Korea