This study is designed to determine safety of and immune response to Venezuelan Equine
Encephalomyelitis Vaccine, Live, Attenuated, Dried TC-83, NDBR-102 (TC-83).
- 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.
- 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.