ACAM2000® Myopericarditis Registry

NCT01395082 | Completed

• 2 other identifiers: H-406-003U1111-1120-1721
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocarditis; Pericarditis

Keywords

Myocarditis; Pericarditis; Vaccinia virus; ACAM2000®; Smallpox vaccine

Outcome Measures

Primary Outcomes (1)

• 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 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

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

Study Arms (1)

Entire registry group

Participants with potential myopericarditis cases referred to the Registry

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Emergent BioSolutions: lead

Study Sites (1)

Unknown Facility

San Diego, California, 92106, United States

Location

MeSH Terms

Conditions

Myocarditis; Pericarditis; Vaccinia

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Medical Director

  Emergent BioSolutions

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 15, 2011
• Study Start: April 1, 2011
• Primary Completion: February 4, 2019
• Study Completion: February 4, 2019
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

US (1)