A Study on the Clinical Course, Outcomes and Risk Factors of Myocarditis and Pericarditis After Moderna COVID-19 Vaccine

Clinical Course, Outcomes and Risk Factors of Myocarditis and Pericarditis Following Administration of mRNA- 1273 (ELASOMERAN)

The main goal of this study is to describe the clinical course, outcomes and risk factors for myocarditis and pericarditis associated with Moderna vaccination targeting SARS-CoV-2.

Study Overview

• Status: Active, not recruiting
• Conditions: Myocarditis, Pericarditis
• Intervention / Treatment: Biological: mRNA-1273

Detailed Description

This study will use an "Moderna vaccination targeting SARS-CoV-2 - exposed case cohort design" to assess the risk factors other than Moderna vaccination targeting SARS-CoV-2 vaccination for the development of myocarditis and pericarditis in Moderna vaccination targeting SARS-CoV-2 recipients, to understand which characteristics increase or decrease the risk for the development of myocarditis and pericarditis after Moderna vaccination targeting SARS-CoV-2 vaccination.

The second design "a myocarditis/pericarditis cohort study design" will be used to describe the prognostic factors for a severe clinical course in participants with myocarditis or pericarditis regardless of vaccination status. As most myocarditis and pericarditis cases are mild in disease severity, it is clinically relevant to identify the participants who are at increased risk for severe clinical outcomes (such as acute coronary syndrome, acute myocardial infarction, heart failure, atrial fibrillation/flutter, ventricular arrhythmias/cardiac arrest, pulmonary embolism or deep venous thrombosis, stroke outcomes, peripheral arterial embolism, hospital readmission, intensive care unit [ICU] admission or death) as early as possible in order to provide appropriate care in a timely manner. Therefore, information available at the onset of myocarditis or pericarditis could be used to predict the clinical course including long-term outcomes.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Aarhus University Hospital
• Norway
  • Oslo, Norway
    • University of Oslo
• Spain
  • Barcelona, Spain
    • IDIAP Jordi Gol
  • Valencia, Spain
    • FISABIO
• United Kingdom
  • Southampton, United Kingdom
    • Drug Safety Research Unit (DSRU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Information regarding participants is collected from multiple databases, utilizing routinely collected health and administrative data of four European countries: Denmark, Norway, Spain, and the United Kingdom. The study databases are representative of the source population in each country.

Description

Inclusion Criteria:

• For the Elasomeran-Moderna vaccination targeting SARS-CoV-2-exposed case-cohort study, a cohort will be defined including participants of all ages with (1) at least one dose of Moderna vaccination targeting SARS-CoV-2 administered during the study period, (2) at least one year of enrolment in the applicable database prior to the index vaccine dose to allow for ascertainment of baseline covariables and potential risk factors, and (3) no myocarditis or pericarditis events within 6 months prior to Moderna vaccination targeting SARS-CoV-2 receipt. Myocarditis and pericarditis cases are defined when adjudication criteria similar to Centers for Disease Control and Prevention (CDC) case definition for probable or definite myocarditis or pericarditis is fulfilled.
• For the cohort study, participants will be included if they: (1) meet the adjudication criteria similar to the CDC case definition for probable or definite myocarditis or pericarditis, (2) have at least one year of enrolment in the applicable database prior to the index myocarditis or pericarditis event to allow for ascertainment of baseline covariates and potential risk factors, and (3) have not received a COVID-19 vaccine other than Moderna vaccination targeting SARS-CoV-2 within 30 days prior to the index myocarditis or pericarditis event.

Exclusion Criteria:

• Participants who have evidence of myocarditis or pericarditis in structured data (for example: ICD-10 codes) where review of clinical data is incompatible with adjudication criteria similar to CDC case definition for myocarditis or pericarditis will be described but will not be included as cases in primary analyses.
• In the Moderna vaccination targeting SARS-CoV-2-exposed case-cohort design, these non-confirmed myocarditis/pericarditis cases will be censored at the onset of the false positive myocarditis/ pericarditis diagnosis.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Moderna vaccination targeting SARS-CoV-2-exposed Case Cohort; All participants with myocarditis are selected among the participants who received at least 1 dose of Moderna vaccination targeting SARS-CoV-2. Cases are those participants who develop myocarditis or pericarditis any time during the follow-up after Moderna vaccination targeting SARS-CoV-2 vaccination.	Biological: mRNA-1273; intramuscular injection; Other Names: Elasomeran; Spikevax; Imelasomeran; Davesomeran; Spikevax bivalent
Myocarditis/Pericarditis Cohort; All participants with myocarditis and/or pericarditis with or without prior Moderna vaccination targeting SARS-CoV-2 exposure will be selected from the available databases.	Biological: mRNA-1273; intramuscular injection; Other Names: Elasomeran; Spikevax; Imelasomeran; Davesomeran; Spikevax bivalent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Myocarditis and/or Pericarditis within 30 Days After Moderna vaccination targeting SARS-CoV-2		Up to 30 days post vaccination
Number of Participants With Severe Clinical Outcomes Within 30 Days After Onset of Myocarditis or Pericarditis	Clinical outcomes comprises of acute coronary syndrome, acute myocardial infarction, heart failure, atrial fibrillation/flutter, ventricular arrhythmias/cardiac arrest, pulmonary embolism or deep venous thrombosis, stroke outcomes, peripheral arterial embolism, hospital readmission, intensive care unit (ICU) admission or death.	Up to 30 days after onset of myocarditis or pericarditis
Number of Participants With Long Term Clinical Outcomes After Onset of Myocarditis and/or Pericarditis		Up to 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Severe Myocarditis or Pericarditis within 30 days After Moderna vaccination targeting SARS-CoV-2	Up to 30 days post vaccination

Collaborators and Investigators

• Sponsor: ModernaTX, Inc.
• Collaborators: Lead Scientific and Operating Center: Julius Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Coronavirus; COVID-19; SARS-CoV-2 Vaccine; Virus Diseases; Moderna; Messenger RNA; Pericarditis; COVID-19 Vaccine; mRNA-1273 vaccine; mRNA-1273; Myocarditis
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Cardiomyopathies; Disease Progression; Myocarditis; Pericarditis
• Other Study ID Numbers: mRNA-1273-P910