Ciprofloxacin BioThrax Co-Administration Study
This study has been completed.
Sponsor:
Emergent BioSolutions
Collaborator:
Information provided by (Responsible Party):
Emergent BioSolutions
ClinicalTrials.gov Identifier:
NCT01753115
First received: December 14, 2012
Last updated: November 18, 2014
Last verified: November 2014
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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:
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:
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:
|
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 |
| 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
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 |
| 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:
|
Ciprofloxacin Anti-Bacterial Agents Anti-Infective Agents Antineoplastic Agents Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Topoisomerase II Inhibitors Topoisomerase Inhibitors |
ClinicalTrials.gov processed this record on February 27, 2015