Ciprofloxacin BioThrax Co-Administration Study

Overview

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)

Full Title of Study: “A Study of The Effects of Co-Administering Ciprofloxacin and BioThrax on the Pharmacokinetics of Ciprofloxacin in Healthy Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2013

Detailed Description

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. This is a randomized, open-label, Phase 2, multi-center trial to investigate the potential interactions of ciprofloxacin and BioThrax.

Interventions

  • Biological: BioThrax
    • route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
  • Drug: Ciprofloxacin
    • 500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48).

Arms, Groups and Cohorts

  • Experimental: BioThrax + Ciprofloxacin PK
    • BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule. Ciprofloxacin: 500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48).
  • Experimental: BioThrax + Ciprofloxacin no PK
    • BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule. Ciprofloxacin: 500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48).
  • Experimental: BioThrax only
    • BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule.

Clinical Trial Outcome Measures

Primary Measures

  • Ratios of Ciprofloxacin Area Under the Curve and Cmax (Day 5/Day 44)
    • Time Frame: Day 5 and Day 44 in Arm 1
    • Ratios of Area Under the Curve from zero to 12 hours (AUC0-12h) and maximum concentration (Cmax) achieved for ciprofloxacin (Day 5/Day 44).

Secondary Measures

  • Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) Levels
    • Time Frame: Two weeks after last vaccination
    • Blood was collected in arms 1 and 2 at day 48 ( 2 weeks following last vaccination) and in arm 3 at day 43 ( 2 weeks following last vaccination) for TNA assay to determine the NF50 antibody titer for calculating GMT.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Emergent BioSolutions
  • Collaborator
    • Department of Health and Human Services
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Robert Hopkins, MD, MPH, TM, Principal Investigator, Emergent BioSolutions Inc.

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