ACAM2000® Myopericarditis Registry

March 15, 2024 updated by: Emergent BioSolutions

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Entire registry group
Participants with potential myopericarditis cases referred to the Registry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years after enrollment or after the last symptoms or positive findings

Other Outcome Measures

Outcome Measure
Time Frame
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
2 years after enrollment or after the last symptoms or positive findings

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emergent BioSolutions

Investigators

  • Study Director: Medical Director, Emergent BioSolutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

February 4, 2019

Study Completion (Actual)

February 4, 2019

Study Registration Dates

First Submitted

July 13, 2011

First Submitted That Met QC Criteria

July 13, 2011

First Posted (Estimated)

July 15, 2011

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-406-003
  • U1111-1120-1721 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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