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

NCT06002503 | Active Not Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: VEEV-PJ-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Conditions

Vaccine Reaction

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• VEEV-specific antibody

  1 year

• Seroconversion rate

  1 year

Study Arms (4)

1: Intramuscular

EXPERIMENTAL

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; Device: PharmaJet Stratis Needle-free Injection System

2: Intramuscular

EXPERIMENTAL

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; Device: PharmaJet Stratis Needle-free Injection System

3: Intradermal

EXPERIMENTAL

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; Device: PharmaJet Tropis Needle-free Injection System

4: Intradermal

EXPERIMENTAL

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; Device: PharmaJet Tropis Needle-free Injection System

Interventions

Venezuelan Equine Encephalitis DNA Vaccine DRUG

Venezuelan Equine Encephalitis DNA Vaccine Candidate

1: Intramuscular; 2: Intramuscular; 3: Intradermal; 4: Intradermal

PharmaJet Stratis Needle-free Injection System DEVICE

Intramuscular Needle-free Injection System (Jet Injector)

1: Intramuscular; 2: Intramuscular

PharmaJet Tropis Needle-free Injection System DEVICE

Intradermal Needle-free Injection System (Jet Injector)

3: Intradermal; 4: Intradermal

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• PharmaJet, Inc.: lead
• United States Department of Defense: collaborator

Study Sites (1)

Velocity Clinical Research

Cincinnati, Ohio, 45246, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 21, 2023
• Study Start: October 16, 2023
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: May 24, 2024

Record last verified: 2024-03

Locations

US (1)