Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-25 @ 5:14 PM
Study NCT ID:
NCT06002503
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2023-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis DNA Vaccine Candidate Administered by Jet Injection
Sponsor:
PharmaJet, Inc.
Organization:
Study Overview
Official Title:
A Phase I, Randomized, Observer-Blind Trial to Assess the Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis (VEE) DNA Vaccine Candidate Administered Intramuscularly and Intradermally by Jet Injection to Healthy Adults
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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 goal of this clinical trial is to evaluate the safety and reactogenicity of a VEE DNA Vaccine candidate delivered by either intramuscular or intradermal jet injection. The main question it aims to answer is:
• Is the VEE DNA Vaccine candidate safe
Participants will:
* Receive the VEE DNA Vaccine candidate by either intramuscular or intradermal jet injection
* Provide blood and urine samples
* Complete ECGs
* Complete physical exams
* Complete diaries
• Is the VEE DNA Vaccine candidate safe
Participants will:
* Receive the VEE DNA Vaccine candidate by either intramuscular or intradermal jet injection
* Provide blood and urine samples
* Complete ECGs
* Complete physical exams
* Complete diaries
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: