Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults
Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults
The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and
 immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and
 female subjects between 18 and 50 years of age will receive vaccinations via the
 intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via
 laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant
 medications, and local and systemic signs and symptoms of reactogenicity.
AV7909 is a new vaccine which is a combination of BioThrax (also called anthrax vaccine,
 adsorbed or AVA), a FDA-licensed vaccine, and CPG 7909. CPG 7909 is a synthetic short DNA
 sequence that has been shown to be an effective vaccine adjuvant, and one which increases the
 speed and the degree of the immune response to Protective Antigen (PA), the major vaccine
 antigen. In the current study, the safety, tolerability, and antibody response to PA will be
 studied for four different combinations of AVA and CPG 7909, and compared to both AVA and a
 saline placebo. All formulations of AV7909 have the same or less AVA than the licensed AVA
 vaccine and all have less CPG 7909 per dose than the formulation used in the first Phase I
 volunteer study of CPG 7909 combined with AVA.
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.