Clinical trial NCT01753115: Ciprofloxacin BioThrax Co-Administration Study
Official title: A Study of The Effects of Co-Administering Ciprofloxacin and BioThrax on the Pharmacokinetics of Ciprofloxacin in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anthrax
Keywords: post-exposure prophylaxis
toxin neutralization assay
Lead sponsor: Emergent BioSolutions
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
First posted: 2012-12-20
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Ratios of Ciprofloxacin Area Under the Curve and Cmax (Day 5/Day 44)
timeFrame: Day 5 and Day 44 in Arm 1
Secondary outcomes:
measure: Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) Levels
timeFrame: Two weeks after last vaccination
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Dallas
country: United States
facility: Research Across America
state: Texas
Study officials:
affiliation: Emergent BioSolutions Inc.
name: Robert Hopkins, MD, MPH, TM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cassie D, Longstreth J, Hopkins R, Hunter-Stitt E, Drobic B, Bellani M. Compatible co-administration of BioThrax(R) vaccine and ciprofloxacin-Results of a randomized open-label drug-vaccine interaction trial. Vaccine X. 2024 Jan 7;17:100431. doi: 10.1016/j.jvacx.2024.100431. eCollection 2024 Mar.