Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine

Exclusion Criteria

• •Prior history of, or known exposure to any form of B. anthracis or any anthrax immunization.
• •Member of the Armed Services (Active Duty or Reserve) since 1990, with history of previous anthrax vaccination.
• •Employment in an industry involved in contact with ruminant animals, veterinary sciences, or other exposure to B. anthracis.
• •Expected to be noncompliant with study visits or planning to move within 8 months.
• •Body mass index of \>35 or \<19.
• •Known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, latex, kanamycin, or any other aminoglycoside antibiotics (such as gentamycin).
• •Pregnancy (positive urine pregnancy test within 24 hours prior to vaccination), or lactation.
• •HIV positive (by history or screening ELISA).
• •Hepatitis B or C positive (by history or screening HBsAg/anti-HCV ELISA).
• •Active or past internal organ, hematologic malignancy, or metastatic cutaneous malignancy.
• •History of, or current autoimmune disease, including but not limited to systemic lupus erythematosus, scleroderma, and polyarteritis.
• •Immunodeficiency or unstable medical condition as determined by baseline medical history, physical exam, and laboratory assessment.
• •Received, or plans to receive, licensed live vaccines within 30 days of study vaccination.
• •Received, or plans to receive, licensed killed vaccines within 14 days of study vaccination.
• •Received, or plans to receive, immunoglobulin or other blood products within 60 days of study vaccination.
• •Received, or plans to receive, experimental drugs/vaccines within 30 days of study vaccination.
• •Received, or plans to receive, systemic immunosuppresive therapy, radiation therapy, or high-dose inhaled steroids within 30 days of study vaccination.
• •Use of systemic chemotherapy within 5 years prior to study.
• •History of Guillain-Barre Syndrome.
• •In addition to the conditions listed above, the following may qualify as a reason to exclude a volunteer from the study: fever along with moderate or serious illness within 3 days of vaccination or any condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the study evaluations. Pending resolution of these symptoms, a volunteer may be reconsidered for vaccination.