Evaluation of Clinical Benefit and Safety Following CYFENDUS Administration for Post-Exposure Prophylaxis of Anthrax Disease.

Emergent BioSolutions

Status: Begins enrollment in a year or more

Conditions: Anthrax

Treatments: Biological: CYFENDUS

Study type: Observational

Funder types: Industry

Identifiers

NCT07268612

EBS-AVA-213

Details and patient eligibility

About

The goal of this observational study is to evaluate the safety and clinical benefit of two doses of CYFENDUS vaccine when used with the concurrent recommended antibacterial regimen for post-exposure prophylaxis to prevent inhalational anthrax and/or anthrax meningitis.

Enrollment: 250 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals who received any dose of CYFENDUS vaccine (with or without concurrent recommended antibacterial regimen) for anthrax post exposure prophylaxis during an identified mass B. anthracis exposure event in the United States.

Exclusion criteria

• Individuals who did not receive CYFENDUS for anthrax post exposure prophylaxis during an identified mass B. anthracis exposure event in the United States.