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

NCT06002503 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-05-24

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • PharmaJet, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-16
Primary Completion
2025-05-31
Completion
2025-05-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06002503 on ClinicalTrials.gov