Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study
Condition: Anthrax
MeSH terms: Anthrax
Intervention: Ciprofloxacin 500Mg Tablet; Doxycycline 100Mg Tablet; AV7909
Intervention description: Ciprofloxacin 500mg administered by mouth every 12 hours. The antibiotic will be administered orally on Study Days 4-9, 22-24 and 31-37.; Doxycycline 100mg administered by mouth every 12 hours. The antibiotic will be administered orally on Study Days 2-9, 22-24 and 32-38.; 0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose.The vaccine will be administered intramuscularly on Study Days 8 and 23.
Intervention MeSH terms: Doxycycline; Ciprofloxacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Antibiotics; Pharmacokinetics; Vaccine; Ciprofloxacin; Doxycycline; CPG 7909; Bacillus anthracis; Anthrax Vaccine Adsorbed; Post-exposure Prophylaxis; Adjuvant

Summary:

      This study is designed to evaluate the pharmacokinetic (PK) profiles of ciprofloxacin or
      doxycycline when administered orally, prior to, and following, the intramuscular (IM)
      administration of a two-dose schedule of AV7909 administered two weeks apart.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent obtained from the participant (dated, signed, and captured in
             the medical chart at the site).

          2. A male or female, aged 18 to 45 years of age, inclusive, at the time of informed
             consent.

          3. Healthy condition as established by medical history and clinical examination before
             entering into the study.

          4. Body mass index (BMI) less than or equal to 35.0 kg/m^2 at the Screening visit.

          5. Have adequate venous access for phlebotomies.

          6. For a woman of childbearing potential (WOCBP), negative pregnancy test at Screening
             and pre-randomization on Day 1, not currently breastfeeding, and no intention to
             become pregnant during the study period through 12 months after last receipt of any
             investigational product (IP). Every female participant is considered to be a WOCBP
             unless she is surgically sterile (hysterectomy, bilateral salpingectomy or bilateral
             oophorectomy) OR postmenopausal (defined as >12 consecutive months without menses and
             screen follicle-stimulating hormone > 30 mIU/mL). Women who are not of childbearing
             potential are allowed to enroll if they are surgically sterile or postmenopausal as
             defined above.

        Female participants randomized to Groups 1 or 2 must be willing to add a double-barrier
        method, IUD, or abstinence as back-up forms of birth control since ciprofloxacin and
        doxycycline may decrease the effectiveness of birth control pills, implantable or
        injectable contraceptives.

        Exclusion Criteria:

          1. A Screening clinical laboratory test result greater than the central laboratory's
             upper limit of normal (ULN) for aspartate aminotransferase (AST), alanine
             aminotransferase (ALT), random glucose, total bilirubin, blood urea nitrogen (BUN), or
             creatinine. Other serum chemistry parameters that are not within the reference range
             will not be considered exclusionary unless deemed clinically significant by the
             principal investigator.

          2. History of allergic reaction or intolerance to quinolone antimicrobials or any medical
             condition that would contraindicate the use of ciprofloxacin, including and not
             limited to vascular disorders, tendon disorders, certain genetic connective tissue
             disorders (e.g., Marfan and Ehlers-Danlos syndrome), prolongation of QT interval,
             seizures, peripheral neuropathy, increased risk of C. difficile infection.

          3. History of allergic reaction or intolerance to tetracycline antibiotics or any medical
             condition that would contraindicate the use of doxycycline including an increased risk
             of C. difficile infection, increases in BUN or an increased sensitivity to direct
             sunlight or ultraviolet radiation resulting in erythema.

          4. Has a need for any of the prohibited medications or requires the medications/foods
             within the prohibited times.

          5. Have a tattoo/scar/birthmark or any other skin condition affecting the deltoid area
             that may interfere with injection site assessments.

          6. History of anthrax disease, suspected exposure to anthrax, or previous vaccination
             with any anthrax vaccine.

          7. Have previously served in the military any time after 1990 or plan to enlist in the
             military any time from Screening through the final telephone contact.

          8. Previous anaphylactic reaction, severe systemic response, or serious hypersensitivity
             to a prior immunization or a known allergy to synthetic ODNs, aluminum, formaldehyde,
             benzethonium chloride (phemerol).

          9. Plan to have an elective surgery at any point during the study until after the final
             safety phone contact.

         10. Have donated or plan to donate blood within one month prior to enrollment or at any
             point during the study until after the final safety phone contact.

         11. Use of any investigational or non-registered product (drug, vaccine or biologic)
             within 30 days preceding the dose of study vaccine, or planned use during the study
             until after the final safety phone contact.

         12. Planned administration of any commercially-available vaccine from one week prior to
             the first study vaccination through two weeks after the last vaccination.

         13. Have experienced chronic dosing (defined as more than 14 days) with any
             immune-modifying drugs within six months of study enrollment. This includes oral,
             intramuscular, intra-articular, intravenous, or inhalation corticosteroids except in
             the case of inhaled or intranasal medications for seasonal allergies.

         14. Receipt of immunoglobulins and/or any blood products within the three months preceding
             study enrollment or at any point during the study period until after the final safety
             visit on Day 51.

         15. An abnormal electrocardiogram (ECG) at screening interpreted as 'Abnormal,
             Significant'. Inclusion of participants with 'Abnormal, Insignificant' ECGs will be
             based on the principal investigator's discretion.

         16. Have an active malignancy or history of metastatic or hematologic malignancy.

         17. Have a history of an autoimmune, inflammatory, vasculitic or rheumaticor rheumatic
             disease including but not limited to systemic lupus erythematosus, Guillain-Barré
             syndrome, myasthenia gravis, polymyalgia rheumatica, diabetes mellitus type I,
             rheumatoid arthritis or scleroderma.

         18. A positive laboratory evidence of hepatitis B, hepatitis C, or human immunodeficiency
             virus (HIV) HIV-1 or HIV-2 infection.

         19. Positive result on urine drug screen, any evidence of ongoing drug abuse or dependence
             (including alcohol), or recent history (over the past five years) of treatment for
             alcohol or drug abuse.

         20. Has an acute disease at the time of enrollment.

         21. Any medical condition that, in the opinion of the investigator, could adversely impact
             the participant's involvement or the conduct of the study.

         22. Have a significant chronic condition, e.g., serious cardiovascular, pulmonary,
             hepatic, type II diabetes mellitus or renal disease that, in the opinion of the
             investigator, would render treatment unsafe or would interfere with trial evaluations
             or completion of the study.

         23. An opinion of the investigator that it would be unwise to allow the participant to be
             randomized into the study.

         24. Member or immediate family member of an investigator site team.