Safety, Tolerability and Immunogenicity of Recombinant Anthrax Vaccine Compared With Anthrax Vaccine Adsorbed

Exclusion Criteria

• •1. Presence of any clinically significant medical condition as determined by the Investigator.
• •2. Medically significant hypersensitivity or idiosyncratic reaction related to any medical product including vaccines.
• •3. History or evidence of drug abuse 1 year prior to enrollment.
• •4. Participation in a clinical study of an investigational vaccine within 3 months prior to the start of the study or an investigational drug product within 30 days prior to the start of the study.
• •5. Use of any prescription or non-prescription medication within 7 days prior to the first dosing with the exception of over-the-counter (OTC) antihistamine, non-steroidal anti-inflammatory drugs (NSAID), acetaminophen, OTC decongestants or oral/injectable/transdermal contraceptives. Any medication taken within 7 days of the first dosing will be recorded.
• •6. History or suspicion of inability to co-operate adequately.
• •7. Donation of blood or blood products for a period of 4 weeks prior to participation in the study.
• •8. Immunodeficiency or clinically active autoimmune disease.
• •9. Positive urine alcohol and drug screen for drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, and barbiturates).
• •10. Positive test for human immunodeficiency virus (HIV), and/or hepatitis B and/or hepatitis C.
• •11. Vaccination(s) with a live vaccine in the previous 4 weeks or killed / inactivated vaccines in the previous 3 weeks.
• •12. Blood or plasma transfusions, or pooled gamma-globulin in the previous 3 months and need for blood or plasma transfusions during this study.
• •13. Received anthrax vaccine or anthrax immune globulin or been otherwise exposed to B. anthracis.
• •14. Clinically relevant abnormal findings on routine physical examination.
• •15. Clinically significant out-of-range laboratory tests at screening including: urinalysis, serum creatine, lactate dehydrogenase (LDH), potassium, glucose, liver function tests (LFT); absolute neutrophil count, platelet count, white blood cell count, electrolytes, clotting and blood hemoglobin.
• •16. Twelve-lead ECG recording with clinically relevant signs of pathology and conduction disturbances as judged by the investigator.
• •17. Presence of tattoos that cover or partially cover the injection sites on the upper arm.
• •18. Known sensitivity to Latex.