Ciprofloxacin BioThrax Co-Administration Study

Phase 2

Completed

• Conditions: Anthrax
• Interventions: Biological: BioThrax; Drug: Ciprofloxacin

• Registration Number: NCT01753115
• Lead Sponsor: Emergent BioSolutions

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-14
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-20
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Results First Submitted: 2014-10-22
• Results First Submitted QC: 2014-11-18
• Results First Posted: 2014-11-19
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BioThrax only	BioThrax	BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule.
BioThrax + Ciprofloxacin no PK	BioThrax	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 + Ciprofloxacin PK	BioThrax	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 + Ciprofloxacin PK	Ciprofloxacin	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 + Ciprofloxacin no PK	Ciprofloxacin	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).

Primary Outcome Measures

Name	Time	Method
Ratios of Ciprofloxacin Area Under the Curve and Cmax (Day 5/Day 44)	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

Name	Time	Method
Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) Levels	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.

Trial Locations

Locations (3)

The Center for Pharmaceutical Research; 🇺🇸 Kansas City, Missouri, United States

Research Across America; 🇺🇸 Dallas, Texas, United States

Meridian Clinical Research; 🇺🇸 Omaha, Nebraska, United States