Status:
ACTIVE_NOT_RECRUITING
Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis DNA Vaccine Candidate Administered by Jet Injection
Lead Sponsor:
PharmaJet, Inc.
Collaborating Sponsors:
United States Department of Defense
Conditions:
Vaccine Reaction
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06002503
Start Date
October 16 2023
End Date
May 31 2025
Last Update
May 24 2024
Active Locations (1)
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1
Velocity Clinical Research
Cincinnati, Ohio, United States, 45246