AnthraxNCT07268612
Evaluation of Clinical Benefit and Safety Following CYFENDUS Administration for Post-Exposure Prophylaxis of Anthrax Disease.
An observational study of Anthrax, run by Emergent BioSolutions.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anthrax
- What is being tested?
- CYFENDUS
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Nov 2035to Nov 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Individuals who did not receive CYFENDUS for anthrax post exposure prophylaxis during an identified mass B. anthracis exposure event in the United States.
About this study
Official title: 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
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.
- Conditions
- Anthrax
- Being tested
- CYFENDUS
- Keywords
- Anthrax, Anthrax meningitis, cutaneous anthrax, gastrointestinal anthrax, inhalational anthrax, CYFENDUS, Anthrax vaccine adsorbed adjuvanted
- Medical subject headings
- Anthrax, Cutaneous anthrax, Gastrointestinal anthrax, Inhalation anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYFENDUSBiological
Intramuscular administration of two doses of Anthrax Vaccine Adsorbed, Adjuvanted
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At least 12 months after containment of the mass exposure event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study startNov 2035 (estimated)
- Primary completionNov 2036 (estimated)
- Study completionNov 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnthraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268612
- Sponsor's protocol ID
- EBS-AVA-213
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07268612
- Acronym / sponsor ID
- EBS-AVA-213
- Conditions
- Anthrax
- Keywords
- Anthrax, Anthrax meningitis, cutaneous anthrax, gastrointestinal anthrax, inhalational anthrax, CYFENDUS, Anthrax vaccine adsorbed adjuvanted
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Study start
- Nov 2035 (estimated)
- Primary completion
- Nov 2036 (estimated)
- Study completion
- Nov 2037 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Individuals who did not receive CYFENDUS for anthrax post exposure prophylaxis during an identified mass B. anthracis exposure event in the United States.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYFENDUSIntramuscular administration of two doses of Anthrax Vaccine Adsorbed, Adjuvanted | Biological | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anthrax, run by Emergent BioSolutions.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.