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

NOT_YET_RECRUITING

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

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

NCT07268612•Emergent BioSolutions

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

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.

Key Dates

Start Date

November 1, 2035

Primary Completion Date

November 1, 2036

Completion Date

November 1, 2037

Last Updated

December 8, 2025

Enrollment

250

ESTIMATED participants

Conditions

Anthrax

Interventions

CYFENDUS

BIOLOGICAL

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AnthraxBacillus Infections

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Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Natural History of Anthrax: a Study of Primary Infected, Recovered, and Exposed Individuals (SPoRE); and Evaluation of AVA-Vaccinated Recipients

Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax

Evaluation of the SRI B. Anthracis Lethal Factor Diagnostic System

An Open Label Field Study of Anthim (Obiltoxaximab) in Subjects Exposed to B. Anthracis

Safety, Tolerability and PK of Intravenous (IV) ETI-204 Alone and in Presence of Ciprofloxacin in Adult Volunteers

Monoclonal Antibody for Treatment of Inhalation Anthrax