Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine

Inclusion Criteria:

- At least 18 years old

- VEE PRNT80 < 1:10 before immunization.

- (females) Negative serum pregnancy test on same day before vaccination. Not planning
pregnancy for 3 months.

- Actively enrolled in the SIP

- At risk for exposure to virulent VEE virus (with up-to-date risk assessment).

- Up-to-date (within 1 year) physical examination/tests.

- Sign and date the approved informed consent.

- Willing to return for all follow-up visits.

- Agree to report adverse event (AE) up to 28 days after vaccination.

Exclusion Criteria:

- Over age of 65 years.

- Clinically significant abnormal lab results including evidence of Hepatitis C,
Hepatitis B carrier state, or elevated liver function tests.

- History of immunodeficiency or current treatment with immunosuppressive medication.

- (females) Currently breastfeeding.

- Confirmed human immunodeficiency virus (HIV) titer.

- Family history (first degree relative, but not elderly parent with late onset)
diabetes, personal history gestational diabetes, or confirmed elevated fasting serum
glucose (> 125 mg/dL).

- Serious allergic reaction to guinea pigs/guinea pig products.

- Any known allergies to components of the vaccine.

- A medical condition that in the judgment of the Principal Investigator (PI) would
impact subject safety (i.e-vaccination and or exposure to another alphavirus).

- Administration of any vaccine within 28 days of TC-83.

- Any unresolved AEs resulting from a previous immunization.