NCT06002503

Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis DNA Vaccine Candidate Administered by Jet Injection

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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: PharmaJet, Inc. · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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

Conditions

• Vaccine Reaction

Interventions

Type	Name	Description
DRUG	Venezuelan Equine Encephalitis DNA Vaccine	Venezuelan Equine Encephalitis DNA Vaccine Candidate
DEVICE	PharmaJet Stratis Needle-free Injection System	Intramuscular Needle-free Injection System (Jet Injector)
DEVICE	PharmaJet Tropis Needle-free Injection System	Intradermal Needle-free Injection System (Jet Injector)

Timeline

• Start date: 2023-10-16
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2023-08-21
• Last updated: 2024-05-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study