Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
Condition: Anthrax
MeSH terms: Anthrax
Intervention: BioThrax
Intervention description: BioThrax, 0.5 mL administered subcutaneously on days 0, 14, and 28.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: post-exposure prophylaxis; toxin neutralization assay

Summary:

      The purpose of this Phase 3 clinical trial is to evaluate the immunogenicity and safety of
      BioThrax anthrax vaccine in healthy adults following 3 doses of BioThrax. Results of this
      study will be used to support a post-exposure prophylaxis (PEP) indication for BioThrax.

      This study will be conducted in the United States (U.S.), in 200 healthy male and female
      volunteer subjects ages 18 to 65 years.

      The duration of study participation for each individual subject will be approximately 128
      days (4.25 months), including a screening period of approximately 28 days followed by 100
      days on study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be between 18 and 65 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.

          -  Be willing and able to return for all visits and blood collections for the duration of
             the study.

          -  Have read, understood and signed an informed consent form.

        Exclusion Criteria:

          -  Prior immunization with anthrax vaccine or known exposure to anthrax organisms.

          -  Intend to enlist in the military during the study.

          -  Have a known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, or
             latex.

          -  Plan to receive experimental products at any time during the study.

          -  Have received a live vaccine in the 30 days before study entry.

          -  Plan to receive a live vaccine at any time during the study.

          -  Have ongoing drug abuse/dependence (including alcohol) issues and/or test positive in
             a urine drug screen for amphetamines, barbiturates, cocaine or opiates;

          -  Have received immunosuppressive therapy (including systemic steroids) within 3 months
             prior to study entry.

          -  Have a condition known to produce or be associated with immunosuppression.

          -  Have received cytotoxic therapy in the previous 5 years.

          -  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.