Ciprofloxacin BioThrax Co-Administration Study

Anthrax Clinical Trial

Official title:

A Study of The Effects of Co-Administering Ciprofloxacin and BioThrax on the Pharmacokinetics of Ciprofloxacin in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753115
• Other study ID #: EBS.AVA.009
• Status: Completed
• Phase: Phase 2
• Start date: December 2012
• Est. completion date: August 2013

Study information

• Verified date: March 2024
• Source: Emergent BioSolutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anthrax

Intervention

Biological:
• BioThrax
route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule

Drug:
• Ciprofloxacin
500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48).

Locations

Country	Name	City	State
United States	Research Across America	Dallas	Texas
United States	The Center for Pharmaceutical Research	Kansas City	Missouri
United States	Meridian Clinical Research	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Emergent BioSolutions	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratios of Ciprofloxacin Area Under the Curve and Cmax (Day 5/Day 44)	Ratios of Area Under the Curve from zero to 12 hours (AUC0-12h) and maximum concentration (Cmax) achieved for ciprofloxacin (Day 5/Day 44).	Day 5 and Day 44 in Arm 1
Secondary	Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) Levels	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.	Two weeks after last vaccination