ACAM2000® Myopericarditis Registry

Sponsor

Emergent BioSolutions (Industry)

Overall Status

Completed

CT.gov ID

NCT01395082

Collaborator

(none)

Enrollment

Location

94.2

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Myocarditis Pericarditis

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

Study Type:

Observational

Actual Enrollment :

24 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

ACAM2000® Myopericarditis Registry

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Feb 4, 2019

Actual Study Completion Date :

Feb 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Entire registry group Participants with potential myopericarditis cases referred to the Registry

Outcome Measures

Primary Outcome Measures

The number of confirmed, probable, suspected, and subclinical cases of myopericarditis, categorized by time since vaccination [2 years after enrollment or after the last symptoms or positive findings]

Other Outcome Measures

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 [2 years after enrollment or after the last symptoms or positive findings]

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.