Ciprofloxacin BioThrax Co-Administration Study - Full Text View

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® (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	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:

MedlinePlus related topics: Anthrax

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Anthrax Vaccine Adsorbed

Genetic and Rare Diseases Information Center resources: Anthrax

U.S. FDA Resources

Further study details as provided by Emergent BioSolutions:

Primary Outcome Measures:

Ratios of Ciprofloxacin Area Under the Curve and Cmax (Day 5/Day 44) [ Time Frame: Day 5 and Day 44 in Arm 1 ] [ Designated as safety issue: No ]
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 [ Time Frame: Two weeks after last vaccination ] [ Designated as safety issue: No ]
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.


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 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

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.

Eligibility


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

Department of Health and Human Services

Investigators


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

More Information


Responsible Party:	Emergent BioSolutions
ClinicalTrials.gov Identifier:	NCT01753115 History of Changes
Other Study ID Numbers:	EBS.AVA.009
Study First Received:	December 14, 2012
Results First Received:	October 22, 2014
Last Updated:	November 18, 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	Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 27, 2016