Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis DNA Vaccine Candidate Administered by Jet Injection
Study Details
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:
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Receive the VEE DNA Vaccine candidate by either intramuscular or intradermal jet injection
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Provide blood and urine samples
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Complete ECGs
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Complete physical exams
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Complete diaries
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| 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
Primary Outcome Measures
- Number of participants with immediate reactions [30 minutes after each vaccination]
The nature, frequency, and severity of immediate reactions following vaccination
- Solicited adverse events [7 days after each vaccination]
The nature, frequency, and severity of solicited adverse events
- Unsolicited adverse events [28 days after the final vaccination]
The nature, frequency, and severity of unsolicited adverse events
- Adverse events [1 year]
The nature, frequency, and severity of adverse events
Secondary Outcome Measures
- VEEV-specific antibody [1 year]
PsVNA50
- Seroconversion rate [1 year]
PsVNA50
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy adults, male or female.
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Ages at least 18 at the start of the study and no greater than 49 years of age on Day 1 of vaccination.
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Participants must be available for all visits and for the complete duration of the study.
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Participants must, in the opinion of the Investigator or person obtaining consent, understand the information provided and be capable of providing informed consent.
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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.
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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:
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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.
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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.
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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).
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If female, pregnant, lactating, or planning pregnancy within 6 months of the final vaccination.
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Receipt of a blood transfusion or blood products 6 months prior to enrollment.
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Participation in another clinical trial of an investigational product currently or within the past 12 weeks or expected participation during the study.
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History of severe local or systemic reactions to vaccination or a history of severe allergic reactions.
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History of Guillain-Barre syndrome.
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Confirmed diagnosis of HBV infection (surface antigen positive, HBsAg); Hepatitis C infection (HCV Ab positive); HIV infection, or active syphilis.
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History of grand mal epilepsy, or currently taking anti-epileptics.
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Any condition associated with prolonged bleeding time, which would contraindicate skin or muscle injection.
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Abnormal ECG finding that, in the opinion of the Investigator, excludes the subject from participating.
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History of syncope or history of a fainting episode within one year of study entry.
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Extensive tattoos or markings covering the eligible sites of administration (the skin or muscle of the upper left and right deltoid muscles).
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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).
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In the opinion of the Investigator, is unlikely to comply with the protocol.
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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.
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A history of encephalitis as confirmed/reported by the study subject.
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Prior immunization against VEEV or related alphavirus or encephalitis, as confirmed/reported by the study subject.
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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.
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Involved in the planning or conduct of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Velocity Clinical Research | Cincinnati | Ohio | United States | 45246 |
Sponsors and Collaborators
- PharmaJet, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VEEV-PJ-01