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

Inclusion Criteria

• •1. Be 18 to 65 years old at time of consent.
• •2. Have EEE virus plaque reduction neutralization 80% titers (PRNT80) \< 1:20 for primary series.
• •3. Have EEE virus PRNT80 \< 1:40 for booster series.
• •4. If female of childbearing potential, must agree to have a urine pregnancy test on the same day before each vaccine. (Exception: documented hysterectomy or ≥ 3 years of menopause.) The results must be negative. Females must agree not to become pregnant for 3 months after receipt of the last study treatment (vaccination).
• •5. Be considered at risk for exposure to EEE virus and who have submitted a Request for IND Vaccines for the EEE vaccine.
• •6. Sign and date the approved informed consent document and HIPAA Authorization.
• •7. Have in their charts:
• •* medical history (including concomitant medications) within 60 days of planned first administration of vaccine
• •* physical examination and laboratory tests within 1 year
• •* previous chest radiograph results and electrocardiogram
• •8. Be medically cleared for participation by an investigator. (Examinations and/or tests may be repeated at the discretion of the principal investigator \[PI\].)
• •9. Be willing to return for all follow-up visits.
• •10. Agree to report any adverse events (AEs) that may or may not be associated with administration of the vaccine for at least 28 days after administration and agree to report all serious adverse events (for example, resulting in hospitalization) for the duration of the subject's participation in the study. Subjects must agree to report any pregnancy that occurs within 3 months after a vaccination.
• •11. Agree to defer blood, bone marrow, and organ donation for 1 year after receipt of the vaccine.