Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine in Healthy Adults

Exclusion Criteria

• •1. Have received VEE vaccine.
• •2. Have family history (first degree relative) of diabetes mellitus (any type), a personal or family history of gestational diabetes, a confirmed elevated fasting serum glucose test (\> 125 mg/dL), or a hemoglobin A1c \> 5.6%. (At the principal investigator's discretion, a subject may participate if the family history of diabetes is only of late onset in an elderly parent.)
• •3. Have clinically significant abnormal laboratory results (including evidence of hepatitis C, hepatitis B carrier state) or elevated liver function tests (two times the normal range or at the discretion of the PI).
• •4. Have a personal history of an immunodeficiency or received treatment with an immunosuppressive medication, such as systemically administered glucocorticoids (eg prednisone) within 1 month before planned administration of the vaccine or with other immunosuppressive therapies within 6 months of planned administration of the vaccine. Other immunosuppressive therapies include all cancer chemotherapeutic agents, drugs to prevent transplant rejection, interferons, monoclonal antibodies, protein kinase inhibitors, methotrexate, TNF (tumor necrosis factor) inhibitors, and any other drug determined to be immunosuppressive by the PI. Current administration of topical, inhalational, or intranasal glucocorticoids is not excluded.
• •5. Have confirmed HIV infection (antibody positivity).
• •6. Have a positive pregnancy test or a breastfeeding female.
• •7. Have any known allergies to components of the vaccine:
• •* Neomycin sulfate
• •* Guinea pig heart cells
• •* Streptomycin
• •* Human serum albumin
• •8. History of serious allergic reaction to guinea pigs or guinea pig products. (Subjects who have known allergies to guinea pigs will be evaluated. The vast majority of individuals who are allergic to guinea pigs are allergic to the dander from the animals. An individual with a past serious allergic reaction to guinea pigs will be excluded.)
• •9. Have administration of another vaccine or investigational product within 28 days of VEE vaccination.
• •10. Have any unresolved AE resulting from a previous immunization.
• •11. Have a medical condition that, in the judgment of the PI, would impact subject safety.