Vaccine Reaction
Conditions
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
Interventions
DRUGVenezuelan Equine Encephalitis DNA Vaccine
Venezuelan Equine Encephalitis DNA Vaccine Candidate
DEVICEPharmaJet Stratis Needle-free Injection System
Intramuscular Needle-free Injection System (Jet Injector)
DEVICEPharmaJet Tropis Needle-free Injection System
Intradermal Needle-free Injection System (Jet Injector)
Sponsors
United States Department of Defense
PharmaJet, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| VEEV-specific antibody | 1 year | PsVNA50 |
| Seroconversion rate | 1 year | PsVNA50 |
Countries
United States
Outcome results
None listed