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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Intramuscular | Experimental | Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26 |
|
| 2: Intramuscular | Experimental | Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4 |
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| 3: Intradermal | Experimental | Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26 |
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| 4: Intradermal | Experimental | Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venezuelan Equine Encephalitis DNA Vaccine | Drug | Venezuelan Equine Encephalitis DNA Vaccine Candidate |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| VEEV-specific antibody | PsVNA50 | 1 year |
| Seroconversion rate | PsVNA50 | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Clinical Research | Cincinnati | Ohio | 45246 | United States |
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| PharmaJet Stratis Needle-free Injection System | Device | Intramuscular Needle-free Injection System (Jet Injector) |
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| PharmaJet Tropis Needle-free Injection System | Device | Intradermal Needle-free Injection System (Jet Injector) |
|