A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels
Condition: Anthrax
MeSH terms: Anthrax
Intervention: AV7909; BioThrax
Intervention description: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 168.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: post-exposure prophylaxis; toxin neutralization assay

Summary:

      The purpose of this study is to assess the safety and immunogenicity of an anthrax vaccine.
      The vaccine schedule and dose will also be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be 18-50 years old

          -  Be in good health

          -  Have access to a computer and the internet so you can complete a diary

          -  Agree to abstain from sex the first 84 days of the study or practice birth control if
             you are a woman who is able to get pregnant

          -  Have not donated blood for the previous 8 weeks

        Exclusion Criteria:

          -  A known anaphylactic response, severe systemic response, or serious hypersensitivity
             reaction to a prior immunization.

          -  A history of latex allergy.

          -  Have received a shot (vaccine), including flu shots, in the past 6 weeks or plan to
             get a shot for 4 weeks after the last study shot is given.

          -  Have previously served in the military any time after 1990 or plan to enlist in the
             military from Screening through Day 84.

          -  Prior immunization with anthrax vaccine, recombinant protective antigen (rPA) vaccine,
             or known exposure to anthrax organisms.

          -  Have participated in anthrax therapeutic or vaccine studies (monoclonal anti-PA or
             anthrax immune globulins or anthrax vaccines).

          -  Participation in any investigational study involving use of a pharmacological
             intervention within 30 days before the Screening visit or planning to participate in a
             study requiring dosing through the 12-month safety follow-up telephone call.

          -  Have a known diagnosis of any immunodeficiency disease including but not limited to:
             acquired immune deficiency syndrome (AIDS), common variable immunodeficiency disease,
             immunoglobulin A (IgA) deficiency, or hypogammaglobulinemia.

          -  Past history of significant autoimmune disease such as rheumatoid arthritis, lupus
             erythematous, psoriasis in the area of vaccinations, or requires immunotherapy,
             glomerulonephritis, or autoimmune thyroiditis.

          -  Have received immunosuppressive therapy with cytotoxic drugs or Rituximab within the
             past 2 years.

          -  A history of cytotoxic chemotherapy or radiation therapy.

          -  Chronic (>10 days) daily oral or parenteral corticosteroid therapy in the past 12
             months.

          -  Any lung disease, including reactive airway disease, which requires the daily use of
             medications.

          -  A female currently breastfeeding or with a positive pregnancy test.

          -  A history of drug or alcohol abuse within 12 months prior to Screening, or a positive
             result on a urine drug screen for cocaine, marijuana, opiates, methamphetamines,
             benzodiazepines, or oxycodone.

          -  Any tattoo or other skin condition in the deltoid region on either arm that may
             obscure the assessment of the injection sites.

          -  A medical condition that, in the opinion of the PI or designee, could adversely impact
             the subject's participation or safety or the conduct of the study.

          -  Any planned elective in-patient surgery during the study period.