ACAM2000® Myopericarditis Registry

Emergent BioSolutions24 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Myocarditis Pericarditis

Eligibility

Sex: ALLMin age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

San Diego, California, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.