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CompletedNCT01395082Updated Mar 18, 2024

ACAM2000® Myopericarditis Registry

An observational study in Myocarditis and Pericarditis, sponsored by Emergent BioSolutions. Completed at 1 site in United States. Open to participants aged 17 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-18.

Sponsored by Emergent BioSolutions · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
24
Ages
17 Years and older
Sex
All
01

Study 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) 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).

02

Conditions studied

  • Myocarditis
  • Pericarditis

Keywords

  • Myocarditis
  • Pericarditis
  • Vaccinia virus
  • ACAM2000®
  • Smallpox vaccine
03

In context

Myocarditis

174 studies on the registry are indexed under Myocarditis; 75 are open to participants now.

This study's enrollment of 24 is below the median of 208 across 120 observational studies indexed under Myocarditis.

Browse Myocarditis 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.

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

04

Who can participate

Ages eligible
17 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Eligible participants will have received previous vaccination with ACAM2000® but will not receive any vaccination as part of the registry.

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 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.

Exclusion criteria

Exclusion Criteria:

  • Individuals not meeting at least one of the case definitions for myopericarditis will not be entered into the Registry.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
24 participants (actual)

Groups and cohorts

  • Entire registry group

    Participants with potential myopericarditis cases referred to the Registry

06

What researchers measure

Primary outcomes

  1. 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

Other outcomes

  1. The natural history of myopericarditis in terms of time to resolution or change in status of myopericarditis and the pattern of changes in status of myopericarditis

    Time frame: 2 years after enrollment or after the last symptoms or positive findings

07

Study locations

1 site
  • San Diego, California 92106, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2011, a primary completion of Feb 2019 and a completion of Feb 2019. It does not say whether these dates are actual or estimated.

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

Registered
Jul 13, 2011
First posted
Jul 15, 2011
Start
Apr 2011
Primary completionActual
Feb 4, 2019
CompletionActual
Feb 4, 2019
Last update
Mar 18, 2024
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 Mar 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01395082
Responsible party
Sponsor
First posted
Jul 15, 2011
Start date
Apr 2011
Primary completion
Feb 4, 2019
Completion
Feb 4, 2019
Last update
Mar 18, 2024

Study contacts

Medical Director
study director · Emergent BioSolutions

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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