Safety and Immunogenicity Study of Recombinant Ricin Toxin A-Chain Vaccine (RVEc™)

Inclusion Criteria

• •Study subjects must be 18-50 years old.
• •Subjects must weigh at least 110 pounds.
• •Subjects must be in good health as judged from medical history, physical examination, EKG and chest x-ray, complete blood count (CBC) with differential, clinical chemistries, urinalysis, hepatitis serology, and HIV antibody test, and be medically cleared for participation by an investigator. If any HIV or hepatitis testing is positive, the individual will be provided with counseling and referral for health care.
• •Females of childbearing potential must have a negative pregnancy test on vaccination day before each dose and agree to not become pregnant or breastfeed for 3 months after the last dose of the vaccine and be willing to use a reliable form of contraception during the study.
• •Study subjects must read and sign an approved informed consent.
• •Study subjects must be willing to complete a subject diary card after each vaccination.
• •Study subjects must be willing to return for all follow-up visits.
• •Study subjects must agree to report any adverse event (AE) that may or may not be associated with administration of the investigational product through the 9-month follow-up visit. Study subjects will report all serious adverse events for the duration of the study.