Ciprofloxacin BioThrax Co-Administration Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Emergent BioSolutions
ClinicalTrials.gov Identifier:
NCT01753115
First received: December 14, 2012
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.

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)


Condition Intervention Phase
Anthrax
Biological: BioThrax
Drug: Ciprofloxacin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of The Effects of Co-Administering Ciprofloxacin and BioThrax on the Pharmacokinetics of Ciprofloxacin in Healthy Adults

Resource links provided by NLM:


Further study details as provided by Emergent BioSolutions:

Primary Outcome Measures:
  • Ciprofloxacin area under the curve [ Time Frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours postdose on Days 1, 5, 40, and 44 in Arm 1. ] [ Designated as safety issue: No ]
    Area under the curve from zero to 12 hours (AUC0-12h) and maximum concentration (Cmax) achieved for ciprofloxacin


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: Days 1 and Day 48 (Arms 1 and 2); Days 1 and 43 (Arm 3) ] [ Designated as safety issue: No ]
    Toxin Neutralizing Antibody (TNA) levels expressed as Geometric Mean Titer (GMT) 2 weeks after last vaccination.


Other Outcome Measures:
  • Safety and tolerability, as evaluated by adverse events and clinical laboratory tests [ Time Frame: Up to 48 days ] [ Designated as safety issue: Yes ]
    Monitoring treatment emergent adverse events (TEAEs), Serious adverse events (SAEs) and clinically significant changes in laboratory parameters from Day 0 to 48 (Arms 1 and 2) or from Day 0 to 43 (Arm 3)


Enrollment: 154
Study Start Date: December 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BioThrax + Ciprofloxacin PK 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
Other Name: Cipro
Experimental: BioThrax + Ciprofloxacin no PK 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
Other Name: Cipro
Experimental: BioThrax only Biological: BioThrax
route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Other Names:
  • Anthrax Vaccine Adsorbed
  • AVA

Detailed Description:

BioThrax® (also called Anthrax Vaccine Adsorbed or AVA) 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 (Cipro) and BioThrax.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753115

Locations
United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, Nebraska
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, Texas
Research Across America
Dallas, Texas, United States, 75234
Sponsors and Collaborators
Emergent BioSolutions
Investigators
Principal Investigator: Robert Hopkins, MD, MPH, TM Emergent BioSolutions Inc.
  More Information

No publications provided

Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT01753115     History of Changes
Other Study ID Numbers: EBS.AVA.009
Study First Received: December 14, 2012
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Emergent BioSolutions:
post-exposure prophylaxis
toxin neutralization assay

Additional relevant MeSH terms:
Anthrax
Bacillaceae Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 19, 2014