Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults

Inclusion Criteria:

• Be between 18 and 50 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.
• Have negative values for the following tests at Screening: Hepatitis C antibody, anti-Human Immunodeficiency Virus (Anti-HIV-1/-2/-O), and anti-Hepatitis B Core Antigen (Anti-HBc).
• Be willing and capable of complying with all aspects of the protocol through completion of the required visits.
• Have not donated blood in the preceding 8 weeks and are willing to not donate blood or plasma within 56 days after dosing.
• Have adequate venous access for repeat phlebotomies.
• Have read, understood and signed an informed consent form.

Exclusion Criteria:

Key Exclusion Criteria:

• A known anaphylactic response, severe systematic response, or serious hypersensitivity reaction to a prior immunization.
• Prior immunization with anthrax vaccine, recombinant Protective Antigen (rPA) vaccine, or known exposure to anthrax organisms.
• Have previously served in the military or plans to enlist in the military from Screening through Day 84.
• Have participated in anthrax therapeutic or vaccine trials (monoclonal anti-protective antigen (PA) or anthrax immune globulins or anthrax vaccines).
• Participation in any investigational clinical trial within 30 days preceding the Screening visit or planning to participate in a clinical trial requiring dosing through the Day 194 visit.
• A history of drug or alcohol abuse within 12 months prior to Screening, or a positive result on a urine drug screen for amphetamines, barbiturates, benzodiazepines, cocaine, marijuana, methylenedioxymethamphetamine opiates, oxycodone, phencyclidine, propoxyphene, or tricyclic antidepressants.
• Blood pressure greater than 145 millimeters of mercury (mmHg) systolic or 90 mmHg diastolic.
• Past history of significant autoimmune disease such as rheumatoid arthritis, lupus erythematous, psoriasis, glomerulonephritis, or autoimmune thyroiditis.
• 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.