Ciprofloxacin BioThrax Co-Administration Study

NCT ID: NCT01753115

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-08-31

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.

Conditions

Anthrax

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

BioThrax

Intervention Type: BIOLOGICAL

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

Ciprofloxacin

Intervention Type: DRUG

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

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).

Group Type: EXPERIMENTAL

BioThrax

Intervention Type: BIOLOGICAL

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

Ciprofloxacin

Intervention Type: DRUG

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

BioThrax only

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

Group Type: EXPERIMENTAL

BioThrax

Intervention Type: BIOLOGICAL

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

Interventions

BioThrax

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

Intervention Type: BIOLOGICAL

Ciprofloxacin

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

Intervention Type: DRUG

Other Intervention Names

Anthrax Vaccine Adsorbed; AVA

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Department of Health and Human Services

FED

Sponsor Role: collaborator

Emergent BioSolutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Hopkins, MD, MPH, TM

Role: PRINCIPAL_INVESTIGATOR

Emergent BioSolutions Inc.

Locations

The Center for Pharmaceutical Research

Kansas City, Missouri, United States

Meridian Clinical Research

Omaha, Nebraska, United States

Research Across America

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 38352727 (View on PubMed)

Other Identifiers

EBS.AVA.009

Identifier Type: -

Identifier Source: org_study_id