Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2026-03-04 @ 1:34 PM
Study NCT ID:
NCT03721718
Status:
COMPLETED
Last Update Posted:
2020-05-27
First Post:
2018-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Safety, Tolerability and Immunogenicity Study of GLS-5300 in Healthy Volunteers
Sponsor:
GeneOne Life Science, Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: