Ciprofloxacin BioThrax Co-Administration Study
Condition: Anthrax
MeSH terms: Anthrax
Intervention: BioThrax; Ciprofloxacin
Intervention description: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule; 500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48).
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: post-exposure prophylaxis; toxin neutralization assay

Summary:

      The purpose of this clinical trial is to determine whether there is any effect on the
      antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of
      BioThrax® (Anthrax Vaccine Adsorbed or AVA).

      This study will be conducted in the United States (US) in 154 healthy male and female
      volunteer subjects ages 18 to 45.

      The duration of study participation for each subject will be approximately 76 days
      (approximately 2.5 months)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be between 18 and 45 years of age, 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.

          -  Be willing and able to return for all follow-up visits and blood and urine collections
             for the duration of the trial

          -  Be willing and able to complete a web-enabled electronic diary and report concomitant
             medications, adverse events, and BioThrax reactogenicity events during the trial

          -  Be able to understand and communicate in English.

        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 30 days prior to study entry or 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 30 days
             prior to trial entry

          -  Have any other condition known to produce or be associated with immunosuppression

          -  Have received cytotoxic therapy in the previous 5 years

          -  A chronic condition that, in the opinion of the Investigator, would render vaccination
             unsafe or would interfere with trial evaluations or completion of the study.