Ciprofloxacin BioThrax Co-Administration Study

Study Description

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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)

Condition or disease	Intervention/treatment	Phase
Anthrax	Biological: BioThrax; Drug: Ciprofloxacin	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	154 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	December 2012
Actual Primary Completion Date :	August 2013
Actual Study Completion Date :	August 2013

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
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

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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

Department of Health and Human Services

Investigators

Principal Investigator:	Robert Hopkins, MD, MPH, TM	Emergent BioSolutions Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Emergent BioSolutions
ClinicalTrials.gov Identifier:	NCT01753115 History of Changes
Other Study ID Numbers:	EBS.AVA.009
First Posted:	December 20, 2012
Results First Posted:	November 19, 2014
Last Update Posted:	November 19, 2014
Last Verified:	November 2014

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	Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 Enzyme Inhibitors