NCT07268612

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started Nov 2035

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
9.9 years until next milestone

Study Start

First participant enrolled

November 1, 2035

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2036

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2037

Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

November 24, 2025

Last Update Submit

December 4, 2025

Conditions

Anthrax

Keywords

AnthraxAnthrax meningitiscutaneous anthraxgastrointestinal anthraxinhalational anthraxCYFENDUSAnthrax vaccine adsorbed adjuvanted

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

CYFENDUSBIOLOGICAL

Intramuscular administration of two doses of Anthrax Vaccine Adsorbed, Adjuvanted

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will include adults for which CYFENDUS is indicated (18 to 65 years of age), but it may include pediatric, pregnant, and geriatric populations if they are vaccinated with CYFENDUS based on public health recommendations as part of outbreak management.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AnthraxCutaneous anthraxGastrointestinal anthraxInhalation anthrax

Condition Hierarchy (Ancestors)

Bacillaceae InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 8, 2025

Study Start (Estimated)

November 1, 2035

Primary Completion (Estimated)

November 1, 2036

Study Completion (Estimated)

November 1, 2037

Last Updated

December 8, 2025

Record last verified: 2025-12