Assessment of the Immunogenicity and Safety of a Dose-Sparing BioThrax® AVA Schedule

Inclusion Criteria

• Subject able to provide informed consent;
• Female or male, 18 through 65 years of age, inclusive;
• If the subject is female and of childbearing potential, she agrees to practice abstinence from sexual intercourse with men (vaginal penetration by a penis, coitus) or use acceptable contraception, initiated at least 30 days prior to the first study vaccination through 56 days after the 6 month boost vaccination in order to avoid pregnancy:
• A woman is considered of childbearing potential unless post-menopausal (>/= 1 year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)
• Acceptable contraception methods are restricted to effective devices (IUDs, NuvaRing®) or licensed hormonal products with use of method for a minimum of 30 days prior to vaccination, condoms with spermicidal agents, monogamous relationship with a vasectomized partner who has been vasectomized for 6 months or more prior to study entry, or successful Essure placement with documented confirmation test at least 3 months after the procedure, and any other Food and Drug Administration (FDA)-approved contraceptive method
• Be willing and able to return for all visits and blood collections for the duration of the study;
• Be able to understand and comply with planned study procedures;
• Agree to complete the memory aid and to report concomitant medications and Adverse Events during the study period.

Further clarification of inclusion/exclusion criteria:

Provided a subject meets all study inclusion criteria and none of the study exclusion criteria, the following conditions will not exclude the subject from study participation:

• History of gestational diabetes;
• Type II diabetes controlled with diet or oral hypoglycemic medications;
• Treated, controlled, uncomplicated hypertension;
• History of coronary artery disease, asymptomatic (New York Heart Association [NYHA] Function Class I), on a stable medical regimen. Persons meeting these criteria must be at least two years post-myocardial infarction, cardiac bypass surgery and/or percutaneous coronary interventions (e.g., angioplasty, stent placement) in order to qualify. Persons with a history of cardiac disease must be under the care of a physician;
• Cured, non-metastatic cancer (excluding hematologic malignancies), disease-free for five years;
• Localized skin cancer, resected (including squamous cell and basal cell carcinomas). Participants with a history of melanoma must be disease-free for five years;
• Exercise-induced bronchospasm controlled with inhaled medication(s) only;
• Mild asthma: Subjects who have not been hospitalized for asthma in the past two years and use only inhalers to control their symptoms will be eligible. Only low to medium doses of inhaled steroids, defined as 100.4 F within 3 days prior to vaccination;
• Have a blood pressure, heart rate or respiratory rate of Grade 2 or higher;
• Have any chronic condition that, in the opinion of the Investigator, would render vaccination unsafe or would interfere with study evaluations or completion of the study;
• Have a total White Blood Cell (WBC) count, Absolute Neutrophil Count (ANC), hemoglobin or platelet count that is Grade 2 or higher;
• Have a creatinine higher than the normal range;
• Have an Alanine Aminotransferase (ALT) of >/= 1.2 x Upper Limit of Normal;
• Have a value higher than trace for glucose and/or protein on urinalysis;
• Have a history of hospitalization for psychiatric illness, suicide attempt, or confinement for danger to self or others, within the past 10 years. (Subjects with a psychiatric disorder [not meeting exclusion criteria, e.g. attention-deficit hyperactivity disorder] that is controlled for a minimum of 3 months and the investigator has determined that the subject's mental status will not compromise the subject's ability to comply with protocol requirements may be enrolled);
• Be taking any of the following psychiatric drugs: aripiprazole,