Compatible co-administration of BioThrax® vaccine and ciprofloxacin-Results of a randomized open-label drug-vaccine interaction trial.

The recommended treatment for post-exposure prophylaxis (PEP) following known/suspected exposure to involves immunization with anthrax vaccine adsorbed (AVA, i.e., BioThrax® vaccine) and a course of antimicrobial therapy.

Phase 3 trial evaluating the immunogenicity and safety of a three-dose BioThrax® regimen for post-exposure prophylaxis in healthy adults.

Background: This study was conducted to support licensure of a post-exposure prophylaxis indication for BioThrax(®) (anthrax vaccine adsorbed) concurrent with antimicrobials for individuals exposed to aerosolized anthrax spores.

Methods: The immunogenicity and safety of a three-dose regimen (0, 2, and 4 weeks) of BioThrax administered subcutaneously (SC) were evaluated in 200 healthy adults 18-65 years of age. Toxin-neutralizing antibody (TNA) was expressed as 50% neutralization factor (NF50) at predetermined time points through Day 100.