The Phase I study will assess the basic safety, tolerability, and immunogenicity of a DNA-based Venezuelan equine encephalitis virus (VEEV)vaccine candidate delivered by electroporation . The study will enroll 40 healthy adult volunteers ages 18-49 and will comprise evaluation of intradermal or intramuscular administration by electroporation. Administration of the vaccine candidate will be at two DNA dose levels (0.5 mg/ml and 2.0 mg/ml) for each route of administration. Electroporation will be administered using the TriGrid Delivery System devices for intramuscular and intradermal delivery. An additional group of subjects will serve as a placebo control, receiving injections of saline with electroporation. The overall goal of this study will be to determine if further human clinical studies of the vaccine candidate are warranted and, if so, to aid in the selection of dose and route of administration for future studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
42
Accelovance
San Diego, California, United States
The nature, frequency, and severity of local and systemic adverse events or serious adverse events associated with electroporation-based administration of the VEEV DNA vaccine candidate
Time frame: 12 months
The frequency, magnitude, and duration of serum anti-VEEV antibody responses
Anti-VEEV immune response will be assessed by 80% Plaque Reducing Neutralization Test (PRNT80). PRNT80 titers of \>= 1:10 will constitute a response.
Time frame: 12 months
Response to a questionnaire based assessment of acute procedure tolerability.
Immediately following procedure administration, subjects will complete a Visual Analog Scale (VAS) based questionnaire to assess procedure tolerability.
Time frame: 8 weeks
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