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New mRNA vaccine aims to shield teens and young adults from common virus

NCT ID NCT05575492

Vaccine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested an experimental mRNA vaccine (mRNA-1647) for cytomegalovirus (CMV) in healthy teens (9–15 years) and young women (16–25 years). The goal was to see if the vaccine is safe and triggers a strong immune response. Participants received either the vaccine or a placebo, and researchers monitored side effects and antibody levels.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

873 people

The number who actually took part.

Started

Nov 2022

Finished

May 2026

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

9 to 25 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.

Key Inclusion Criteria: * Is a female or male 9 to 15 years of age or is a female 16 to 25 years of age at the time of consent. * Is in good general health, in the opinion of the Investigator, and is capable of complying with study procedures. * For the CMV-seronegative cohorts: At the Screening visit, is CMV IgG-negative and CMV immunoglobulin M (IgM)-negative. * For the CMV-seropositive cohorts: At the Screening visit, is CMV IgG-positive and CMV IgM-negative, CMV IgG-positive and CMV IgM-positive, or CMV IgG-positive and CMV IgM-indeterminate. Participants with an isolated positive or indeterminate result for CMV IgM (that is, CMV IgG-negative and either CMV IgM-positive or CMV IgM-indeterminate) will not be eligible for enrollment but may be rescreened after at least 6 weeks from the initial CMV Screening. Participants with an indeterminate result for CMV IgG, regardless of IgM result, will not be eligible for enrollment but may be rescreened after at least 6 weeks from the initial CMV screening. * If 9 to 15 years of age, has a body mass index (BMI) at or above the third percentile according to World Health Organization (WHO) Child Growth Standards. If 16 to 25 years of age: has a BMI of 15 to 35 kilograms (kg)/square meter (m\^2). * For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 3 months following vaccine administration. Key Exclusion Criteria: * Has a history of a diagnosis or condition that, in the judgment of Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. Clinically unstable is defined as diagnosis or condition requiring significant changes in management or medication within the 2 months prior to Screening and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition. * Has received, or plans to receive, any nonstudy vaccine \< 28 days prior to or after any study injection. * Has a screening liver function test (aspartate aminotransferase, alanine aminotransferase, total bilirubin) or a screening creatinine result of Toxicity Grade ≥1. * Has a Screening hematology or coagulation result of Toxicity Grade ≥1. * Is acutely ill or febrile (body temperature ≥38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) at the Screening Visit. * Has received systemic immunosuppressants or immune-modifying drugs for \> 14 days in total within 6 months prior to the day of enrollment (for corticosteroids, ≥1 milligrams (mg)/kg/day or ≥10 mg/day prednisone equivalent). * Has received an antiviral with activity against CMV (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir, acyclovir, valacyclovir) \<2 weeks prior to the day of the first study injection (Day 1) or plans to do so during the course of the study. * Reports a history of myocarditis, pericarditis, or myopericarditis. * Has reported medical history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV); or a positive screening test for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV 1 or 2 antibodies. * Has previously received an investigational CMV vaccine. * Has received systemic immunoglobulins or blood products \<3 months prior to the day of the first study injection (Day 1). * Has donated ≥ 450 milliliter (mL) of blood products \<28 days prior to the day of the first study injection (Day 1). * Has participated in an interventional clinical study \<28 days prior to the day of the first study injection (Day 1) or plans to do so while enrolled in the study. Note: Other inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

cytomegalovirus infection prevention target

As listed by the trial registrant

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

Cytomegalovirus

Contacts and locations

Locations

  • ALTA Clinical Research Inc

    Edmonton, Alberta, Canada

  • Albuquerque Clinical Trials Inc - Clinedge - PPDS

    Albuquerque, New Mexico, 87102-2619, United States

  • Benchmark Research - Covington - HyperCore- PPDS

    Covington, Louisiana, 70433, United States

  • Benchmark Research - Fort Worth - HyperCore -PPDS

    Fort Worth, Texas, 76135, United States

  • Benchmark Research - Sacramento -Hypercore- PPDS

    Sacramento, California, 95864, United States

  • Benchmark Research - San Angelo - HyperCore - PPDS

    San Angelo, Texas, 76904, United States

  • Bluewater Clinical Research Group

    Sarnia, Ontario, Canada

  • CARe Clinic

    Red Deer, Alberta, Canada

  • Canadian Center for Vaccinology

    Halifax, Nova Scotia, Canada

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec, Canada

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322-1014, United States

  • Clinical Neurosciences Solutions Inc. (Orlando-East South St)

    Orlando, Florida, 32801-2987, United States

  • Clinical Research Prime - ClinEdge - PPDS

    Idaho Falls, Idaho, 83404-5305, United States

  • Crossroads Clinical Research (Victoria)

    Victoria, Texas, 77901, United States

  • DM Clinical Research - ERN- PPDS

    Tomball, Texas, 77375, United States

  • Hamilton Medical Research Group

    Hamilton, Ontario, Canada

  • JBR Clinical Research - CenExel JBR - PPDS

    Salt Lake City, Utah, 84107-4536, United States

  • Lakeside Healthcare

    Corby, Northamptonshire, United Kingdom

  • Lynn Institute of Norman - ERN - PPDS

    Norman, Oklahoma, 73072-3251, United States

  • M.A.G.I.C. Clinic Ltd. Metabolics and Genetics in Calgary

    Calgary, Alberta, Canada

  • Meharry Medical College

    Nashville, Tennessee, 37208, United States

  • Noah's Ark Children's Hospital for Wales

    Cardiff, United Kingdom

  • OnSite Clinical Solutions, LLC - ClinEdge - PPDS

    Charlotte, North Carolina, 28277-4859, United States

  • Palm Harbor Dermatology

    Tampa, Florida, 33609-2230, United States

  • Paradigm Clinical Research Institute Inc - ClinEdge - PPDS

    La Mesa, California, 91942-3189, United States

  • Prohealth Research Center

    Doral, Florida, 33166-6613, United States

  • Queen Elizabeth Hospital

    Birmingham, United Kingdom

  • Rochester Clinical Research, Inc

    Rochester, New York, 14609-3173, United States

  • Santos Research Center

    Tampa, Florida, 33615-3219, United States

  • Sheffield Children's Hospital

    Sheffield, South Yorkshire, United Kingdom

  • Southampton General Hospital

    Southampton, Hampshire, United Kingdom

  • St. George Hospital

    London, United Kingdom

  • Tekton Research - Beaumont - Platinum - PPDS

    Beaumont, Texas, 77706-3061, United States

  • Tekton Research - Fort Collins - Platinum - PPDS

    Fort Collins, Colorado, 80525-5752, United States

  • Tekton Research - Oklahoma- PPDS

    Edmond, Oklahoma, 73013, United States

  • Tekton Research - Texas - PPDS

    Austin, Texas, 78705, United States

  • Tekton Research - Texas - Platinum - PPDS

    San Antonio, Texas, 78229, United States

  • The Pediatric Centre

    Columbia, Maryland, 21045, United States

  • The Pediatric Centre of Frederick

    Frederick, Maryland, 21702, United States

  • Tulane Medical Center

    New Orleans, Louisiana, 70112-2632, United States

  • University of Florida Jacksonville

    Jacksonville, Florida, 32209, United States

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201-1509, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Texas Medical Branch (UTMB)

    Galveston, Texas, 77550, United States

  • Velocity Clinical Research (Binghamton - New York) - PPDS

    Binghamton, New York, 13901-1046, United States

  • Velocity Clinical Research (Lincoln-Nebraska) - PPDS

    Lincoln, Nebraska, 68510, United States

  • Velocity Clinical Research (Norfolk - Nebraska) - PPDS

    Norfolk, Nebraska, 68701-7701, United States

  • Velocity Clinical Research (Omaha-Nebraska) - Platinum - PPDS

    Omaha, Nebraska, 68134-3664, United States

  • Velocity Clinical Research (Washington)- PPDS

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

  • Velocity Clinical Research - Gulfport

    Gulfport, Mississippi, 39503, United States

  • Velocity Clinical Research - Medford - PPDS

    Medford, Oregon, 97504-7738, United States

  • Velocity Clinical Research - San Diego - PPDS

    La Mesa, California, 91942, United States

  • Velocity Clinical Research -Albuquerque -PPDS

    Albuquerque, New Mexico, 87102-3644, United States

  • Victoria Clinical Research Group

    Port Lavaca, Texas, 77979, United States

  • Wayne State University

    Detroit, Michigan, 48201, United States

  • West Houston Clinical Research - Hunt - PPDS

    Houston, Texas, 77055-1626, United States

  • iResearch Atlanta - CenExel - PPDS

    Decatur, Georgia, 30030-3438, United States

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