MyocarditisNCT01395082
ACAM2000® Myopericarditis Registry
An observational study of Myocarditis and Pericarditis, run by Emergent BioSolutions at 1 site in United States.
Trial summary
The purpose of this registry is to study the natural history of vaccination-related myocarditis and pericarditis and to assess possible risk factors for these conditions. Primary Objective: To document the natural history of confirmed, probable, suspected, and subclinical myocarditis and pericarditis (myopericarditis)… Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocarditis, Pericarditis
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to 4 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Eligible participants will have received previous vaccination with ACAM2000® but will not receive any vaccination as part of the registry.
Who may be able to join
- Individuals who are current or former members of the active duty, Reserve, or National Guard, from any branch of service
- Documented vaccination with ACAM2000® vaccine
- Meet one of the case definitions for suspect, probable, confirmed or subclinical myopericarditis.
Who cannot join
- Individuals not meeting at least one of the case definitions for myopericarditis will not be entered into the Registry.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this registry is to study the natural history of vaccination-related myocarditis and pericarditis and to assess possible risk factors for these conditions.
Primary Objective:
- To document the natural history of confirmed, probable, suspected, and subclinical myocarditis and pericarditis (myopericarditis) following ACAM2000® vaccination.
Other Pre-defined Objective:
- To look for potential predictive factors for the prognosis of myopericarditis following ACAM2000® vaccination.
Read the detailed description
All participants will have received previous vaccination with ACAM2000 but will not receive any vaccination as part of the registry. All participants enrolled in the registry will be followed for 2 up to 5 years (depending on whether there are persisting signs and symptoms of myopericarditis).
- Conditions
- Myocarditis, Pericarditis
- Keywords
- Myocarditis, Pericarditis, Vaccinia virus, ACAM2000®, Smallpox vaccine
- Medical subject headings
- Myocarditis, Pericarditis, Vaccinia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Entire registry group | Participants with potential myopericarditis cases referred to the Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of confirmed, probable, suspected, and subclinical cases of myopericarditis, categorized by time since vaccination
Measured: 2 years after enrollment or after the last symptoms or positive findings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startApr 2011
- Primary completion4 Feb 2019
- Study completion4 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyocarditisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Emergent BioSolutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395082
- Sponsor's protocol ID
- H-406-003
- Other IDs
- U1111-1120-1721
- Status last verified
- Mar 2024
- First submitted
- 13 Jul 2011
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACAM2000® Myopericarditis Registry
- ClinicalTrials.gov ID
- NCT01395082
- Acronym / sponsor ID
- H-406-003
- Conditions
- Myocarditis, Pericarditis
- Keywords
- Myocarditis, Pericarditis, Vaccinia virus, ACAM2000®, Smallpox vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 4 Feb 2019 (actual)
- First posted
- 15 Jul 2011 (estimated)
- 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 purpose of this registry is to study the natural history of vaccination-related myocarditis and pericarditis and to assess possible risk factors for these conditions.
Primary Objective:
- To document the natural history of confirmed, probable, suspected, and subclinical myocarditis and pericarditis (myopericarditis) following ACAM2000® vaccination.
Other Pre-defined Objective:
- To look for potential predictive factors for the prognosis of myopericarditis following ACAM2000® vaccination.
Detailed description
All participants will have received previous vaccination with ACAM2000 but will not receive any vaccination as part of the registry. All participants enrolled in the registry will be followed for 2 up to 5 years (depending on whether there are persisting signs and symptoms of myopericarditis).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entire registry group | – | –Participants with potential myopericarditis cases referred to the Registry |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible participants will have received previous vaccination with ACAM2000® but will not receive any vaccination as part of the registry.
Key inclusion criteria (3 listed)
- Individuals who are current or former members of the active duty, Reserve, or National Guard, from any branch of service
- Documented vaccination with ACAM2000® vaccine
- Meet one of the case definitions for suspect, probable, confirmed or subclinical myopericarditis.
Key exclusion criteria (1 listed)
- Individuals not meeting at least one of the case definitions for myopericarditis will not be entered into the Registry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of confirmed, probable, suspected, and subclinical cases of myopericarditis, categorized by time since vaccination
Time frame: 2 years after enrollment or after the last symptoms or positive findings
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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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. This study is not recruiting at the moment.
Medical Director study director
Emergent BioSolutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis and Pericarditis, run by Emergent BioSolutions at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of confirmed, probable, suspected, and subclinical cases of myopericarditis, categorized by time since vaccination (time frame: 2 years after enrollment or after the last symptoms or positive findings). 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 18 Mar 2024.