Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT05182567
Status:
UNKNOWN
Last Update Posted:
2023-09-13
First Post:
2022-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GLS-5310 Vaccine in Healthy Volunteers as a Booster for SARS-CoV-2 (COVID-19)
Sponsor:
GeneOne Life Science, Inc.
Organization:
Study Overview
Official Title:
Safety, Tolerability and Immunogenicity of GLS-5310 DNA Vaccine Given as a Booster to Those Previously Vaccinated Against SARS-CoV-2
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Phase I study to assess the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine given as a booster to those previously vaccinated against SARS-CoV-2
Detailed Description:
This Phase I, randomized, placebo-controlled study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA vaccine administered intradermally (ID) with or without concomitant intranasal (IN) administration given as a heterologous booster dose to those previously vaccinated against SARS-CoV-2.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: