Ciprofloxacin BioThrax Co-Administration Study
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ClinicalTrials.gov Identifier: NCT01753115 |
Recruitment Status
:
Completed
First Posted
: December 20, 2012
Results First Posted
: November 19, 2014
Last Update Posted
: November 19, 2014
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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 |
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 |

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:
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:
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:
|
- 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).
- 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.

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753115
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 |
Principal Investigator: | Robert Hopkins, MD, MPH, TM | Emergent BioSolutions Inc. |
Responsible Party: | Emergent BioSolutions |
ClinicalTrials.gov Identifier: | NCT01753115 History of Changes |
Other Study ID Numbers: |
EBS.AVA.009 |
First Posted: | December 20, 2012 Key Record Dates |
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 |