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

Primary Purpose

Vaccine Reaction

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Venezuelan Equine Encephalitis DNA Vaccine
PharmaJet Stratis Needle-free Injection System
PharmaJet Tropis Needle-free Injection System
Sponsored by
PharmaJet, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vaccine Reaction

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Velocity Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1: Intramuscular

2: Intramuscular

3: Intradermal

4: Intradermal

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Number of participants with immediate reactions
The nature, frequency, and severity of immediate reactions following vaccination
Solicited adverse events
The nature, frequency, and severity of solicited adverse events
Unsolicited adverse events
The nature, frequency, and severity of unsolicited adverse events
Adverse events
The nature, frequency, and severity of adverse events

Secondary Outcome Measures

VEEV-specific antibody
PsVNA50
Seroconversion rate
PsVNA50

Full Information

First Posted
August 8, 2023
Last Updated
October 19, 2023
Sponsor
PharmaJet, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06002503
Brief Title
Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis DNA Vaccine Candidate Administered by Jet Injection
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2023 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PharmaJet, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccine Reaction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1: Intramuscular
Arm Type
Experimental
Arm Description
Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26
Arm Title
2: Intramuscular
Arm Type
Experimental
Arm Description
Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4
Arm Title
3: Intradermal
Arm Type
Experimental
Arm Description
Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26
Arm Title
4: Intradermal
Arm Type
Experimental
Arm Description
Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4
Intervention Type
Drug
Intervention Name(s)
Venezuelan Equine Encephalitis DNA Vaccine
Intervention Description
Venezuelan Equine Encephalitis DNA Vaccine Candidate
Intervention Type
Device
Intervention Name(s)
PharmaJet Stratis Needle-free Injection System
Intervention Description
Intramuscular Needle-free Injection System (Jet Injector)
Intervention Type
Device
Intervention Name(s)
PharmaJet Tropis Needle-free Injection System
Intervention Description
Intradermal Needle-free Injection System (Jet Injector)
Primary Outcome Measure Information:
Title
Number of participants with immediate reactions
Description
The nature, frequency, and severity of immediate reactions following vaccination
Time Frame
30 minutes after each vaccination
Title
Solicited adverse events
Description
The nature, frequency, and severity of solicited adverse events
Time Frame
7 days after each vaccination
Title
Unsolicited adverse events
Description
The nature, frequency, and severity of unsolicited adverse events
Time Frame
28 days after the final vaccination
Title
Adverse events
Description
The nature, frequency, and severity of adverse events
Time Frame
1 year
Secondary Outcome Measure Information:
Title
VEEV-specific antibody
Description
PsVNA50
Time Frame
1 year
Title
Seroconversion rate
Description
PsVNA50
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mara Kinney, MS
Phone
720-214-9390
Email
mara.kinney@pharmajet.com
Facility Information:
Facility Name
Velocity Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Wenker, MD
Phone
513-671-8080
Email
info@velocityclinical.com

12. IPD Sharing Statement

Learn more about this trial

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

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