Ciprofloxacin BioThrax Co-Administration Study

NCT01753115 | Completed Phase 2 Results

• 1 other identifier: EBS.AVA.009
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 3

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)

Conditions

Anthrax

Keywords

post-exposure prophylaxis; toxin neutralization assay

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) Levels

  Two weeks after last vaccination

Study Arms (3)

BioThrax + Ciprofloxacin PK

EXPERIMENTAL

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; Drug: Ciprofloxacin

BioThrax + Ciprofloxacin no PK

EXPERIMENTAL

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; Drug: Ciprofloxacin

BioThrax only

EXPERIMENTAL

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

Biological: BioThrax

Interventions

BioThrax BIOLOGICAL

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

Also known as: Anthrax Vaccine Adsorbed, AVA

BioThrax + Ciprofloxacin PK; BioThrax + Ciprofloxacin no PK; BioThrax only

Ciprofloxacin DRUG

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

BioThrax + Ciprofloxacin PK; BioThrax + Ciprofloxacin no PK

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emergent BioSolutions: lead
• Department of Health and Human Services: collaborator

Study Sites (3)

The Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Meridian Clinical Research

Omaha, Nebraska, 68134, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Related Publications (1)

• 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.

  PMID: 38352727 RESULT

MeSH Terms

Conditions

Anthrax

Interventions

Biothrax; Anthrax Vaccines; Ciprofloxacin

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Robert Hopkins, MD, MPH & TM, FACP, FIDSA, Medical Monitor
• Organization: Emergent BioSolutions

HopkinsR@ebsi.com

301-944-0136

Study Officials

• Robert Hopkins, MD, MPH, TM

  Emergent BioSolutions Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 20, 2012
• Study Start: December 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 15, 2025
• Results First Posted: November 19, 2014

Record last verified: 2025-05

Locations

US (3)