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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06002503
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : March 25, 2024
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
PharmaJet, Inc.

Study Description
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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

Condition or disease Intervention/treatment Phase
Vaccine Reaction Drug: Venezuelan Equine Encephalitis DNA Vaccine Device: PharmaJet Stratis Needle-free Injection System Device: PharmaJet Tropis Needle-free Injection System Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : October 16, 2023
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : May 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with immediate reactions [ Time Frame: 30 minutes after each vaccination ]
    The nature, frequency, and severity of immediate reactions following vaccination

  2. Solicited adverse events [ Time Frame: 7 days after each vaccination ]
    The nature, frequency, and severity of solicited adverse events

  3. Unsolicited adverse events [ Time Frame: 28 days after the final vaccination ]
    The nature, frequency, and severity of unsolicited adverse events

  4. Adverse events [ Time Frame: 1 year ]
    The nature, frequency, and severity of adverse events


Secondary Outcome Measures :
  1. VEEV-specific antibody [ Time Frame: 1 year ]
    PsVNA50

  2. Seroconversion rate [ Time Frame: 1 year ]
    PsVNA50


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06002503


Contacts
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Contact: Mara Kinney, MS 720-214-9390 mara.kinney@pharmajet.com

Locations
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United States, Ohio
Velocity Clinical Research Recruiting
Cincinnati, Ohio, United States, 45246
Contact: Matthew Wenker, MD    513-671-8080    info@velocityclinical.com   
Sponsors and Collaborators
PharmaJet, Inc.
United States Department of Defense
More Information
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Responsible Party: PharmaJet, Inc.
ClinicalTrials.gov Identifier: NCT06002503    
Other Study ID Numbers: VEEV-PJ-01
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: March 25, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Encephalomyelitis, Equine
Encephalomyelitis, Venezuelan Equine
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuroinflammatory Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
Central Nervous System Infections
Infections
 Encephalomyelitis
Infectious Encephalitis
Alphavirus Infections
Arbovirus Infections
Vector Borne Diseases
Encephalitis, Arbovirus
Mosquito-Borne Diseases
Virus Diseases
Togaviridae Infections
RNA Virus Infections