Ciprofloxacin BioThrax Co-Administration Study
Primary Purpose
Anthrax
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BioThrax
Ciprofloxacin
Sponsored by
About this trial
This is an interventional treatment trial for Anthrax focused on measuring post-exposure prophylaxis, toxin neutralization assay
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.
Sites / Locations
- The Center for Pharmaceutical Research
- Meridian Clinical Research
- Research Across America
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
BioThrax + Ciprofloxacin PK
BioThrax + Ciprofloxacin no PK
BioThrax only
Arm Description
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).
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).
BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01753115
First Posted
December 14, 2012
Last Updated
November 18, 2014
Sponsor
Emergent BioSolutions
Collaborators
Department of Health and Human Services
1. Study Identification
Unique Protocol Identification Number
NCT01753115
Brief Title
Ciprofloxacin BioThrax Co-Administration Study
Official Title
A Study of The Effects of Co-Administering Ciprofloxacin and BioThrax on the Pharmacokinetics of Ciprofloxacin in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Emergent BioSolutions
Collaborators
Department of Health and Human Services
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anthrax
Keywords
post-exposure prophylaxis, toxin neutralization assay
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BioThrax + Ciprofloxacin PK
Arm Type
Experimental
Arm Description
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).
Arm Title
BioThrax + Ciprofloxacin no PK
Arm Type
Experimental
Arm Description
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).
Arm Title
BioThrax only
Arm Type
Experimental
Arm Description
BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule.
Intervention Type
Biological
Intervention Name(s)
BioThrax
Other Intervention Name(s)
Anthrax Vaccine Adsorbed, AVA
Intervention Description
route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Intervention Description
500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48).
Primary Outcome Measure Information:
Title
Ratios of Ciprofloxacin Area Under the Curve and Cmax (Day 5/Day 44)
Description
Ratios of Area Under the Curve from zero to 12 hours (AUC0-12h) and maximum concentration (Cmax) achieved for ciprofloxacin (Day 5/Day 44).
Time Frame
Day 5 and Day 44 in Arm 1
Secondary Outcome Measure Information:
Title
Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) Levels
Description
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.
Time Frame
Two weeks after last vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Hopkins, MD, MPH, TM
Organizational Affiliation
Emergent BioSolutions Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
12. IPD Sharing Statement
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Ciprofloxacin BioThrax Co-Administration Study
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