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

NCT07268612 — Not yet recruiting, 250 participants, Emergent BioSolutions

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A Phase 4 Retrospective Observational Study of CYFENDUS™ Anthrax Vaccine Among Individuals Who Received Post-Exposure Prophylaxis Vaccination During a Bacillus Anthracis Mass Exposure Event

Registry	NCT07268612
Status	Not yet recruiting
Study type	Observational
Enrollment	250 (Estimated)
Sponsor	Emergent BioSolutions (Industry)
Conditions	Anthrax
Interventions	CYFENDUS (Biological)
Dates	start 2035-11-01 (estimated), primary completion 2036-11-01 (estimated), completion 2037-11-01 (estimated), first posted 2025-12-08, last updated 2025-12-08

-Summary

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.

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+Arms and interventions

CYFENDUS (Biological): Intramuscular administration of two doses of Anthrax Vaccine Adsorbed, Adjuvanted

+Outcome measures

Primary outcomes

Number of individuals who developed inhalational anthrax and/or anthrax meningitis and received CYFENDUS for post exposure prophylaxis divided by the total number reported to have received CYFENDUS for post exposure prophylaxis. [At least 12 months after containment of the mass exposure event]

+Eligibility

Sex: All

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.