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OpenTrials
Completed

NCT Number: NCT01395082

ACAM2000® Myopericarditis Registry

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.

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Key information

Conditions

Myocarditis Cardiomyopathies Cardiovascular Diseases DNA Virus Infections Heart Diseases Infections Pericarditis Poxviridae Infections Vaccinia Virus Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Diego, California, 92106, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Emergent BioSolutions

Industry

Registry information

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Jul 15, 2011
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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