IM Recombinant Ricin Toxin Vaccine (RVEc) - 3-Dose Primary Series With Boost

Inclusion Criteria

• •Study participants must read and sign an approved informed consent.
• •Study participants must be at least 18 years old at time of screening and no older than 50 years old at time of first study vaccination.
• •Participants must weigh at least 110 pounds at time of screening.
• •Participants must be in good health as judged from medical history, physical examination, electrocardiogram, chest x-ray, hematology, clinical chemistries, urinalysis, hepatitis serology, and human immunodeficiency virus antibody test and must be medically cleared for participation by an investigator.
• •Females of childbearing potential must have a negative pregnancy test on screening and the morning of each vaccination prior to receipt of the vaccine and must agree to use a highly effective method of birth control from screening through 3 months following last study vaccination. A highly effective method of birth control is defined as one with a failure rate of less than 1% per year. Acceptable birth control methods that meet this criterion include hormonal implants and injectables, combined oral contraceptives, intrauterine devices (IUDs), female sterilization (tubal ligation), sexual abstinence, or a vasectomized partner.
• •Female participants must also agree not to breastfeed from screening through 3 months following last study vaccination.
• •Study participants must be willing to return for all follow-up visits.
• •Study participants must agree to report any adverse events (AE) that may or may not be associated with administration of the investigational product through duration of study participation.
• •Study participants must agree to abstain from excessive exercise (more than the usual routine) and excessive alcohol consumption (exceeds 2 drinks for males or exceeds 1 drink for females daily or binge drinking) for the duration of study participation.