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Not yet recruitingNCT07268612Updated Dec 8, 2025

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

An observational study in Anthrax, sponsored by Emergent BioSolutions. Not yet recruiting. Per ClinicalTrials.gov, last updated 2025-12-08.

Sponsored by Emergent BioSolutions · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
250
Sex
All
01

Study 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.

02

Conditions studied

  • Anthrax

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Keywords

  • Anthrax
  • Anthrax meningitis
  • cutaneous anthrax
  • gastrointestinal anthrax
  • inhalational anthrax
  • CYFENDUS
  • Anthrax vaccine adsorbed adjuvanted
03

In context

Anthrax

75 studies on the registry are indexed under Anthrax; 12 are open to participants now.

This study's planned enrollment of 250 is above the median of 99 across 16 observational studies indexed under Anthrax.

Browse Anthrax studies →

Lead sponsor

Emergent BioSolutions is the lead sponsor of 47 studies on the registry; 7 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.

Browse Emergent BioSolutions studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
250 participants (estimated)
Patient registry
No

Interventions

  • BiologicalCYFENDUS

    Intramuscular administration of two doses of Anthrax Vaccine Adsorbed, Adjuvanted

06

What researchers measure

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.

    Time frame: At least 12 months after containment of the mass exposure event

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2035; primary completion for Nov 2036, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 24, 2025
First posted
Dec 8, 2025
StartEst.
Nov 2035
Primary completionEst.
Nov 2036
CompletionEst.
Nov 2037
Last update
Dec 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07268612
Lead sponsor
Emergent BioSolutions
Responsible party
Sponsor
First posted
Dec 8, 2025
Start date
Nov 2035 (estimated)
Primary completion
Nov 2036 (estimated)
Completion
Nov 2037 (estimated)
Last update
Dec 8, 2025

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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