Ciprofloxacin BioThrax Co-Administration Study

Phase 2 Completed 154 enrolled Emergent BioSolutions Department of Health and Human Services · collab

RandomizedParallel-groupOpen-labelTreatment

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)

Timeline

Start: 2012-12
Primary completion: 2013-08
Completion: 2013-08

Outcome

Met primary endpoint

paper The trial met all prospectively defined success criteria for the primary PK endpoint PMID 38352727 ↗

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BioThrax	Vaccine	0.5 ml	Subcutaneous
Subject	Ciprofloxacin	Small molecule	500 mg	Oral