Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine (VEE C-84) as a Booster to VEE TC-83

Study Objectives:

Primary:

To assess safety of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84,
TSI GSD 205, as a booster vaccination as a single dose or a three-dose series, and To assess
immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI
GSD 205, as a booster vaccination as a single dose or a three-dose series

Secondary:

To assess incidence of VEE infection in C-84 boosted personnel.

Inclusion Criteria:

- At least 18 years old.

- VEE PRNT80 < 1:20 before immunization.

- (females) Negative urine pregnancy test on the 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).

- Previous TC-83 vaccination

- 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.

- 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 C-84.

- Any unresolved AEs resulting from a previous immunization.