Safety and Immunogenicity Study of Eastern Equine Encephalitis (EEE) Vaccine

The primary objectives are to assess the safety of Eastern Equine Encephalitis Vaccine,
Inactivated, Dried EEE, TSI GSD 104, and to assess immunogenicity of Eastern Equine
Encephalitis Vaccine, Inactivated, Dried EEE, TSI GSD 104.

Inclusion Criteria:

- At least 18 years old.

- EEE PRNT80 ≤ 1:20.

- EEE PRNT80 ≤ 1:40 for booster series

- (females) Negative pregnancy test on the same day before vaccination.

- Not planning pregnancy for 3 months.

- At risk for exposure to virulent EEE 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 events (AE) up to 28 days after each vaccination.

Exclusion Criteria:

- Over 65 years of age (for Primary Immunization).

- Clinically significant abnormal lab results including evidence of Hepatitis C,
Hepatitis B carrier state, or elevated (2X normal) 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 or exposure to another Alphavirus).

- Administration of any IND product or live vaccine within 28 days of EEE.

- Any unresolved AEs resulting from a previous immunization.