Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study

Phase 2 Completed 210 enrolled Emergent BioSolutions Biomedical Advanced Research and Development Authority · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

This study is designed to evaluate the pharmacokinetic (PK) profiles of ciprofloxacin or doxycycline when administered orally, prior to, and following, the intramuscular (IM) administration of a two-dose schedule of AV7909 administered two weeks apart.

Timeline

Start: 2019-08-12
Primary completion: 2020-03-05
Completion: 2020-03-19

Outcome

Mixed primary results

paper The PK endpoint was met for ciprofloxacin. PMID 41447782 ↗

paper The lower bound of the 90 % CI for Cmax [90 % CI: 0.7841,1.0271] was below the equivalence limits [0.80, 1.25] PMID 41447782 ↗

Publications

Drobic B, Akintunde G, Kim J, Mirceta M, Beach M, Komlenovic V. Effect of Co-administration of the anthrax vaccine adsorbed, adjuvanted with ciprofloxacin or doxycycline on antibiotic pharmacokinetics and the vaccine immunogenicity: A phase 2 drug-vaccine interaction study. Vaccine. 2026 Feb 15;73:128135. doi: 10.1016/j.vaccine.2025.128135. Epub 2025 Dec 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BACILLUS ANTHRACIS PROTECTIVE ANTIGEN, ADSORBED	Vaccine	0.5 ml	Intramuscular
Subject	Ciprofloxacin	Small molecule	500 mg	Oral
Subject	Doxycycline	Small molecule	100 mg	Oral