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

NCT ID: NCT06002503

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2025-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1: Intramuscular

Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26

Group Type: EXPERIMENTAL

Venezuelan Equine Encephalitis DNA Vaccine

Intervention Type: DRUG

Venezuelan Equine Encephalitis DNA Vaccine Candidate

PharmaJet Stratis Needle-free Injection System

Intervention Type: DEVICE

Intramuscular Needle-free Injection System (Jet Injector)

2: Intramuscular

Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4

Group Type: EXPERIMENTAL

Venezuelan Equine Encephalitis DNA Vaccine

Intervention Type: DRUG

Venezuelan Equine Encephalitis DNA Vaccine Candidate

PharmaJet Stratis Needle-free Injection System

Intervention Type: DEVICE

Intramuscular Needle-free Injection System (Jet Injector)

3: Intradermal

Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26

Group Type: EXPERIMENTAL

Venezuelan Equine Encephalitis DNA Vaccine

Intervention Type: DRUG

Venezuelan Equine Encephalitis DNA Vaccine Candidate

PharmaJet Tropis Needle-free Injection System

Intervention Type: DEVICE

Intradermal Needle-free Injection System (Jet Injector)

4: Intradermal

Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4

Group Type: EXPERIMENTAL

Venezuelan Equine Encephalitis DNA Vaccine

Intervention Type: DRUG

Venezuelan Equine Encephalitis DNA Vaccine Candidate

PharmaJet Tropis Needle-free Injection System

Intervention Type: DEVICE

Intradermal Needle-free Injection System (Jet Injector)

Interventions

Venezuelan Equine Encephalitis DNA Vaccine

Venezuelan Equine Encephalitis DNA Vaccine Candidate

Intervention Type: DRUG

PharmaJet Stratis Needle-free Injection System

Intramuscular Needle-free Injection System (Jet Injector)

Intervention Type: DEVICE

PharmaJet Tropis Needle-free Injection System

Intradermal Needle-free Injection System (Jet Injector)

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

PharmaJet, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Velocity Clinical Research

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

VEEV-PJ-01

Identifier Type: -

Identifier Source: org_study_id