Study of a DNA-based Venezuelan Equine Encephalitis Virus DNA Vaccine Administered by Electroporation in Healthy Volunteers

Inclusion Criteria:

- Healthy adult male or non-pregnant, non-lactating female, ages 18-49 (inclusive) at
time of screening

- Have provided written informed consent before screening

- Free of clinically significant health problems or clinical lab abnormalities, as
determined by pertinent medical history, lab evaluations, and clinical examination
before entry into the study

- Available and able to participate for all study visits and procedures

- If sexually active, known to be at least 1 year post-menopausal, or willing to use an
effective method of contraception (e.g., birth control pill, diaphragm, cervical cap,
intrauterine device, condom, anatomical sterility [self or partner]) from the date of
screening until at least 6 months after the last injection

- Negative VEEV IgG antibody test result at screening (ELISA)

Exclusion Criteria:

- History or serologic evidence of prior infection with VEE virus or prior
participation in a VEE virus vaccine trial

- History of severe local or systemic reactions to any vaccination or a history of
severe allergic reactions

- History of Guillain-Barre Syndrome

- Ongoing participation in another clinical trial

- Receipt or planned receipt of any experimental or licensed vaccine, except for a
licensed seasonal influenza vaccine, within the period 30 days prior to initial
injection through 60 days after the Day 70 follow-up. (~ 6 month period in total)

- Receipt or planned receipt of any allergy treatments involving antigen injections
within the period 30 days prior to the first injection through the period 60 days
after Study Day 70 (~6 month period in total)

- Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue
for the eligible injection sites (left and right medial deltoid region) exceeds 40 mm

- Individuals in whom the ability to observe possible local reactions at the eligible
injection sites (deltoid region) is, in the opinion of the investigator, unacceptably
obscured due to a physical condition or permanent body art

- Therapeutic or traumatic metal implant in the skin or muscle of either deltoid
region.

- Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, or
hepatic or renal functional abnormality as determined by the investigator based on
medical history, physical examination, EKG, and/or laboratory screening test

- Pregnant or lactating female, or female who intends to become pregnant during the
study period

- Administration of immunoglobulins and/or any blood products within the 120 days
preceding study entry or planned administration during the study period

- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
HIV infection

- Administration of chronic (defined as more than 14 days) immunosuppressant's or other
immune-modifying drugs within 6 months of study entry

- For corticosteroids, this will mean prednisone, or equivalent, greater than or equal
to 0.5 mg/kg/day; Inhaled and topical steroids are allowed

- Any chronic or active neurologic disorder, including seizures and epilepsy, excluding
a single febrile seizure as a child

- Syncopal episode within 12 months of screening

- Suspected or known current alcohol abuse as defined by the American Psychiatric
Association in DSM IV (Diagnostic and Statistical Manual of Mental Disorders-4th
edition)

- Chronic or active illicit and/or intravenous drug use by history

- Unwilling to allow storage and use of blood for future alphavirus-related research

- Any other significant finding that in the opinion of the investigator would increase
the risk of the individual having an adverse outcome from participating in this study