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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Vaccine Reaction
• Intervention / Treatment: Drug: Venezuelan Equine Encephalitis DNA Vaccine; Device: PharmaJet Stratis Needle-free Injection System; Device: PharmaJet Tropis Needle-free Injection System

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45246
      • Velocity Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy adults, male or female.
• Ages at least 18 at the start of the study and no greater than 49 years of age on Day 1 of vaccination.
• Participants must be available for all visits and for the complete duration of the study.
• Participants must, in the opinion of the Investigator or person obtaining consent, understand the information provided and be capable of providing informed consent.
• Women of child bearing potential (WOCBP) must have a negative pregnancy test and be willing to use an effective method of contraception: oral contraception, diaphragm, cervical cap, intrauterine device, condom, or be anatomically sterile (in self or partner) from the date of screening until at least 6 months after the last vaccination.
• If subject is a sexually active male, must be willing to use an effective method of contraception (such as condoms or be anatomically sterile) from screening until 6 months after the last vaccination.

Exclusion Criteria:

• Clinically relevant abnormality on history or examination including a history of immunodeficiency or use of systemic corticosteroids, immunosuppressive, anticancer, or other medications considered to be significant by the designated trial physician in the last 6 months.
• Any acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in the opinion of the Investigator, would preclude participation.
• Any of the following laboratory parameters with abnormal values that are moderate in severity: hematology (hemoglobin, absolute neutrophil count, absolute lymphocyte count, platelets); urinalysis; biochemistries (total bilirubin, creatinine, AST, ALT).
• If female, pregnant, lactating, or planning pregnancy within 6 months of the final vaccination.
• Receipt of a blood transfusion or blood products 6 months prior to enrollment.
• Participation in another clinical trial of an investigational product currently or within the past 12 weeks or expected participation during the study.
• History of severe local or systemic reactions to vaccination or a history of severe allergic reactions.
• History of Guillain-Barre syndrome.
• Confirmed diagnosis of HBV infection (surface antigen positive, HBsAg); Hepatitis C infection (HCV Ab positive); HIV infection, or active syphilis.
• History of grand mal epilepsy, or currently taking anti-epileptics.
• Any condition associated with prolonged bleeding time, which would contraindicate skin or muscle injection.
• Abnormal ECG finding that, in the opinion of the Investigator, excludes the subject from participating.
• History of syncope or history of a fainting episode within one year of study entry.
• Extensive tattoos or markings covering the eligible sites of administration (the skin or muscle of the upper left and right deltoid muscles).
• Presence of any surgical/traumatic metal implants, or significant scar tissue that may impair appropriate injection at the eligible sites of administration (skin or muscle of the upper left and right deltoid muscles).
• In the opinion of the Investigator, is unlikely to comply with the protocol.
• As confirmed/reported by the study subject, a history of: exposure to Venezuelan Equine Encephalitis Virus (VEEV) or related alphavirus; prior immunization with an alphavirus replicon-based vaccine; prior immunization with a live-attenuated alphavirus vaccine; prior immunization with an inactivated alphavirus vaccine.
• A history of encephalitis as confirmed/reported by the study subject.
• Prior immunization against VEEV or related alphavirus or encephalitis, as confirmed/reported by the study subject.
• History of alcohol abuse, illicit drug use, physical dependence on any opioid, or any history of drug abuse (excluding marijuana) or addiction within 12 months of screening.
• Involved in the planning or conduct of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1: Intramuscular; Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26	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)
Experimental: 2: Intramuscular; Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4	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)
Experimental: 3: Intradermal; Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26	Drug: Venezuelan Equine Encephalitis DNA Vaccine; Venezuelan Equine Encephalitis DNA Vaccine Candidate; Device: PharmaJet Tropis Needle-free Injection System; Intradermal Needle-free Injection System (Jet Injector)
Experimental: 4: Intradermal; Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4	Drug: Venezuelan Equine Encephalitis DNA Vaccine; Venezuelan Equine Encephalitis DNA Vaccine Candidate; Device: PharmaJet Tropis Needle-free Injection System; Intradermal Needle-free Injection System (Jet Injector)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with immediate reactions	The nature, frequency, and severity of immediate reactions following vaccination	30 minutes after each vaccination
Solicited adverse events	The nature, frequency, and severity of solicited adverse events	7 days after each vaccination
Unsolicited adverse events	The nature, frequency, and severity of unsolicited adverse events	28 days after the final vaccination
Adverse events	The nature, frequency, and severity of adverse events	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VEEV-specific antibody	PsVNA50	1 year
Seroconversion rate	PsVNA50	1 year

Collaborators and Investigators

• Sponsor: PharmaJet, Inc.
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Encephalomyelitis; Alphavirus Infections; Togaviridae Infections; Neuroinflammatory Diseases; Mosquito-Borne Diseases; Encephalitis; Encephalomyelitis, Equine; Encephalomyelitis, Venezuelan Equine
• Other Study ID Numbers: VEEV-PJ-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes