Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine

A Phase 2 Open-Label, Safety and Immunogenicity Study of a Single Dose of Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried, TC-83, NDBR-102, as Primary Immunization in Healthy Adults At Risk for Exposure to Virulent Venezuelan Equine Encephalomyelitis Virus

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).

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.