Ciprofloxacin BioThrax Co-Administration Study

A Study of The Effects of Co-Administering Ciprofloxacin and BioThrax on the Pharmacokinetics of Ciprofloxacin in Healthy Adults

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)

Study Overview

• Status: Completed
• Conditions: Anthrax
• Intervention / Treatment: Biological: BioThrax; Drug: Ciprofloxacin

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.

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • The Center for Pharmaceutical Research
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research
  • Texas
    • Dallas, Texas, United States, 75234
      • Research Across America

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Biological: BioThrax; route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule; Other Names: Anthrax Vaccine Adsorbed; AVA; Drug: 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).	Biological: BioThrax; route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule; Other Names: Anthrax Vaccine Adsorbed; AVA; Drug: 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.	Biological: BioThrax; route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule; Other Names: Anthrax Vaccine Adsorbed; AVA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) Levels	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.	Two weeks after last vaccination

Collaborators and Investigators

• Sponsor: Emergent BioSolutions
• Collaborators: Department of Health and Human Services
• Investigators: Principal Investigator: Robert Hopkins, MD, MPH, TM, Emergent BioSolutions Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: December 14, 2012
• First Submitted That Met QC Criteria: December 19, 2012
• First Posted (Estimated): December 20, 2012

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: post-exposure prophylaxis; toxin neutralization assay
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Bacillaceae Infections; Anthrax; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: EBS.AVA.009