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Heart enzyme levels tracked after updated mRNA shot in 1,000 youth

NCT ID NCT06634797

Knowledge-focused Sponsor: ModernaTX, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 4 study tested whether an updated COVID-19 vaccine (mRNA-1273.712) affects heart muscle in healthy people aged 12 to 30. Researchers measured a heart enzyme called troponin in 1,000 participants who received either the vaccine or a placebo. The goal was to see if the vaccine causes any temporary heart stress, helping to understand its safety profile in younger populations.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mRNA-1273.712 vaccine
What this could lead to
If successful, this could provide reassurance that the updated mRNA vaccine does not cause heart muscle injury in young people.
What could go wrong
This is a completed safety study, not designed to prove the vaccine works. Results may not apply to other age groups or vaccine types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1,000 people

The number who actually took part.

Started

Oct 2024

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 30 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Investigator's assessment that participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures. 2. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF). 3. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: 1. History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic. 2. Has known history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 3 months prior to enrollment. 3. Has a documented history of myocarditis or pericarditis. 4. Is acutely ill or febrile (temperature ≥38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) less than 72 hours prior to or at the Screening Visit or Day 1. 5. Has known conditions that may cause elevated cTnI. * Cardiac disease/conditions including rhythm disorders and congenital heart disease * Diabetes * Uncontrolled hypertension (defined as systolic blood pressure \>140 millimeter of mercury (mmHg) or diastolic blood pressure \>90 mmHg) * Alcohol or substance abuse * Kidney disease * Severe obesity, defined as body mass index (BMI) ≥40 kilograms per square meter (kg/m\^2) (\>20 years) or severe obesity defined as BMI for sex and age ≥120% of the 95th percentile \[BMI ≥35 kg/m\^2\] (for 12 to 20 years) 6. Currently has symptomatic acute or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization for worsening disease, at the discretion of the Investigator. 7. Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment. 8. Reported history of congenital or acquired immunodeficiency (eg, human immunodeficiency virus \[HIV\]), immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections disease. 9. History of Guillain-Barré syndrome. 10. Receipt of the following: * Coronavirus disease 2019 (COVID-19) vaccine within 3 months prior to the first injection or if planning to receive at any time during the study (except for study intervention). * Any other licensed vaccine within 28 days before the study injection or planned receipt prior to end of study (EOS). * Systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to Screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. * Systemic immunoglobulins or blood products within 3 months prior to the Screening/Baseline Visit or plans for receipt during the study.

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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers

Contacts and locations

Locations

  • Velocity Clinical Research, Abilene

    Abilene, Texas, 79606, United States

  • Velocity Clinical Research, Albuquerque

    Albuquerque, New Mexico, 87107, United States

  • Velocity Clinical Research, Anderson

    Anderson, South Carolina, 29621, United States

  • Velocity Clinical Research, Banning

    San Bernardino, California, 82408, United States

  • Velocity Clinical Research, Boise

    Meridian, Idaho, 83642, United States

  • Velocity Clinical Research, Cincinnati

    Cincinnati, Ohio, 45246, United States

  • Velocity Clinical Research, Cincinnati, Blue Ash

    Blue Ash, Ohio, 45242, United States

  • Velocity Clinical Research, Cleveland

    Beachwood, Ohio, 44122, United States

  • Velocity Clinical Research, Covington

    Covington, Louisiana, 70433, United States

  • Velocity Clinical Research, Durham

    Durham, North Carolina, 27701, United States

  • Velocity Clinical Research, Grand Island

    Grand Island, Nebraska, 68803, United States

  • Velocity Clinical Research, Gulfport

    Gulfport, Mississippi, 39503, United States

  • Velocity Clinical Research, Huntington Park

    Huntington Park, California, 90255, United States

  • Velocity Clinical Research, Lafayette

    Lafayette, Louisiana, 70508, United States

  • Velocity Clinical Research, Lincoln

    Lincoln, Nebraska, 68510, United States

  • Velocity Clinical Research, New Orleans

    New Orleans, Louisiana, 70119, United States

  • Velocity Clinical Research, Omaha

    Omaha, Nebraska, 68134, United States

  • Velocity Clinical Research, Phoenix

    Phoenix, Arizona, 85006, United States

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088, United States

  • Velocity Clinical Research, San Diego

    La Mesa, California, 91942, United States

  • Velocity Clinical Research, Savannah

    Savannah, Georgia, 31406, United States

  • Velocity Clinical Research, Syracuse

    East Syracuse, New York, 13057, United States

  • Velocity Clinical Research, Valparaiso

    Valparaiso, Indiana, 46383, United States

  • Velocity Clinical Research, Washington DC

    Washington D.C., District of Columbia, 20016, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.