Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults
Condition: Bacillus Anthracis (Anthrax) Infection
MeSH terms: Anthrax
Intervention: BioThrax; AV7909 Formulation 1; AV7909 Formulation 2; AV7909 Formulation 3; AV7909 Formulation 4; Control
Intervention description: BioThrax; AV7909 Formulation 1; AV7909 Formulation 2; AV7909 Formulation 3; AV7909 Formulation 4; Saline control
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: AVA; AV7909; Anthrax vaccine

Summary:

      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.
    

Eligibility criteria:

        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.