Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults

Inclusion Criteria:

• Be between 18 and 65 years of age, inclusive, at the time of enrollment.
• Be in good health as determined by the investigator from medical history and a physical examination.
• If a pre-menopausal female, must be using acceptable methods of birth control.
• Have all hematology and chemistry parameters (measured at Screening) within the laboratory's normal range.
• Be willing and able to return for all visits and blood collections for the duration of the study.
• Have read, understood and signed an informed consent form.

Exclusion Criteria:

• Prior immunization with anthrax vaccine or known exposure to anthrax organisms.
• Intend to enlist in the military during the study.
• Have a known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, or latex.
• Plan to receive experimental products at any time during the study.
• Have received a live vaccine in the 30 days before study entry.
• Plan to receive a live vaccine at any time during the study.
• Have ongoing drug abuse/dependence (including alcohol) issues and/or test positive in a urine drug screen for amphetamines, barbiturates, cocaine or opiates;
• Have received immunosuppressive therapy (including systemic steroids) within 3 months prior to study entry.
• Have a condition known to produce or be associated with immunosuppression.
• Have received cytotoxic therapy in the previous 5 years.
• A medical condition that, in the opinion of the Principal Investigator (PI), could adversely impact the subject's participation, safety, or conduct of the study.