A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age

Last updated: March 22, 2025
Sponsor: ModernaTX, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Hiv

Treatment

Placebo

mRNA-1647

Clinical Study ID

NCT05575492
mRNA-1647-P104
2022-001545-20
  • Ages 9-25
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The main purpose of study is to evaluate the safety and immunogenicity of different dose levels of mRNA-1647 versus control in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive female and male participants 9 to 15 years of age. In addition, mRNA-1647 will be evaluated in female participants 16 to 25 years as a comparator cohort.

Eligibility Criteria

Inclusion

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 thetime of consent.

  • Is in good general health, in the opinion of the Investigator, and is capable ofcomplying with study procedures.

  • For the CMV-seronegative cohorts: At the Screening visit, is CMV IgG-negative andCMV immunoglobulin M (IgM)-negative.

  • For CMV-seropositive cohorts: At the Screening visit, is CMV IgG-positive and CMVIgM-negative, CMV IgG-positive and CMV IgM-positive, or CMV IgG-positive and CMVIgM-indeterminate. Participants with an isolated positive or indeterminate resultfor CMV IgM (that is, CMV IgG-negative and either CMV IgM-positive or CMVIgM-indeterminate) will not be eligible for enrollment but may be rescreened afterat least 6 weeks from the initial CMV Screening. Participants with an indeterminateresult for CMV IgG, regardless of IgM result, will not be eligible for enrollmentbut 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 thirdpercentile 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, adequatecontraception or has abstained from all activities that could result in pregnancyfor at least 28 days prior to Day 1, agreement to continue adequate contraceptionthrough 3 months following vaccine administration.

Exclusion

Key Exclusion Criteria:

  • Has a history of a diagnosis or condition that, in the judgment of Investigator, isclinically unstable or may affect participant safety, assessment of safetyendpoints, assessment of immune response, or adherence to study procedures.Clinically unstable is defined as diagnosis or condition requiring significantchanges in management or medication within the 2 months prior to Screening andincludes ongoing workup of an undiagnosed illness that could lead to a new diagnosisor condition.

  • Has received, or plans to receive, any nonstudy vaccine < 28 days prior to or afterany study injection.

  • Has a screening liver function test (aspartate aminotransferase, alanineaminotransferase, total bilirubin) or a screening creatinine result of ToxicityGrade ≥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 degreesFahrenheit [°F]) at the Screening Visit.

  • Has received systemic immunosuppressants or immune-modifying drugs for > 14 days intotal within 6 months prior to the day of enrollment (for corticosteroids, ≥1milligrams (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 dayof the first study injection (Day 1) or plans to do so during the course of thestudy.

  • Reports a history of myocarditis, pericarditis, or myopericarditis.

  • Has reported medical history of hepatitis B, hepatitis C, or human immunodeficiencyvirus (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 dayof the first study injection (Day 1).

  • Has donated ≥ 450 milliliter (mL) of blood products <28 days prior to the day of thefirst study injection (Day 1).

  • Has participated in an interventional clinical study <28 days prior to the day ofthe first study injection (Day 1) or plans to do so while enrolled in the study.

Note: Other inclusion and exclusion criteria may apply.

Study Design

Total Participants: 770
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1/2
Study Start date:
November 07, 2022
Estimated Completion Date:
January 15, 2027

Study Description

The study will be conducted in 2 parts: Part 1 Dose-Ranging and Part 2 Safety Expansion.

Connect with a study center

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

    Calgary, Alberta
    Canada

    Active - Recruiting

  • ALTA Clinical Research Inc

    Edmonton, Alberta
    Canada

    Active - Recruiting

  • CARe Clinic

    Red Deer, Alberta
    Canada

    Active - Recruiting

  • Canadian Center for Vaccinology

    Halifax, Nova Scotia
    Canada

    Active - Recruiting

  • Hamilton Medical Research Group

    Hamilton, Ontario
    Canada

    Site Not Available

  • Bluewater Clinical Research Group

    Sarnia, Ontario
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec
    Canada

    Active - Recruiting

  • Medicentres Canada Incorporated

    Edmonton,
    Canada

    Active - Recruiting

  • Addenbrooke's Hospital

    Cambridge, Cambridgeshire
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, Hampshire
    United Kingdom

    Active - Recruiting

  • Manchester Royal Infirmary - PPDS

    Manchester, Lancashire
    United Kingdom

    Active - Recruiting

  • Lakeside Healthcare

    Corby, Northamptonshire
    United Kingdom

    Active - Recruiting

  • Sheffield Children's Hospital

    Sheffield, South Yorkshire
    United Kingdom

    Active - Recruiting

  • Queen Elizabeth Hospital

    Birmingham,
    United Kingdom

    Site Not Available

  • Noah's Ark Children's Hospital for Wales

    Cardiff,
    United Kingdom

    Active - Recruiting

  • St. George Hospital

    London,
    United Kingdom

    Active - Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Paradigm Clinical Research Institute Inc - ClinEdge - PPDS

    La Mesa, California 91942-3189
    United States

    Active - Recruiting

  • Velocity Clinical Research - San Diego - PPDS

    La Mesa, California 91942
    United States

    Active - Recruiting

  • Benchmark Research - Sacramento -Hypercore- PPDS

    Sacramento, California 95864
    United States

    Active - Recruiting

  • Tekton Research - Fort Collins - Platinum - PPDS

    Fort Collins, Colorado 80525-5752
    United States

    Active - Recruiting

  • Meridian Clinical Research, LLC - Washington - Platinum - PPDS

    Washington, District of Columbia 20016
    United States

    Site Not Available

  • Velocity Clinical Research (Washington)- PPDS

    Washington, District of Columbia 20016
    United States

    Active - Recruiting

  • Prohealth Research Center

    Doral, Florida 33166-6613
    United States

    Active - Recruiting

  • Clinical Neuroscience Solutions Inc (Jacksonville-Belfort Rd)

    Jacksonville, Florida 32256-6040
    United States

    Active - Recruiting

  • University of Florida Jacksonville

    Jacksonville, Florida 32209
    United States

    Active - Recruiting

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

    Orlando, Florida 32801-2987
    United States

    Active - Recruiting

  • Palm Harbor Dermatology

    Tampa, Florida 33609-2230
    United States

    Active - Recruiting

  • Santos Research Center

    Tampa, Florida 33615-3219
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta

    Atlanta, Georgia 30322-1014
    United States

    Active - Recruiting

  • Tekton Research - Georgia - Platinum - PPDS

    Chamblee, Georgia 30341
    United States

    Site Not Available

  • Centricity Research Roswell

    Columbus, Georgia 31904-8946
    United States

    Active - Recruiting

  • IACT Health - Roswell - IACT - HyperCore - PPDS

    Columbus, Georgia 31904-8946
    United States

    Site Not Available

  • iResearch Atlanta - CenExel - PPDS

    Decatur, Georgia 30030-3438
    United States

    Active - Recruiting

  • Clinical Research Prime - ClinEdge - PPDS

    Idaho Falls, Idaho 83404-5305
    United States

    Active - Recruiting

  • Benchmark Research - Covington - HyperCore- PPDS

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Tulane Medical Center

    New Orleans, Louisiana 70112-2632
    United States

    Active - Recruiting

  • University of Maryland School of Medicine

    Baltimore, Maryland 21201-1509
    United States

    Active - Recruiting

  • The Pediatric Centre

    Columbia, Maryland 21045
    United States

    Active - Recruiting

  • The Pediatric Centre of Frederick

    Frederick, Maryland 21702
    United States

    Active - Recruiting

  • Wayne State University

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Velocity Clinical Research - Gulfport

    Gulfport, Mississippi 39503
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research - Kansas City

    Kansas City, Missouri 64114-4859
    United States

    Site Not Available

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

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Velocity Clinical Research (Lincoln-Nebraska) - PPDS

    Lincoln, Nebraska 68510
    United States

    Active - Recruiting

  • Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDS

    Norfolk, Nebraska 68701-7701
    United States

    Site Not Available

  • Velocity Clinical Research (Norfolk - Nebraska) - PPDS

    Norfolk, Nebraska 68701-7701
    United States

    Active - Recruiting

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

    Omaha, Nebraska 68134-3664
    United States

    Site Not Available

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

    Omaha, Nebraska 68134-3664
    United States

    Active - Recruiting

  • Adekunle Adeoti LLC

    East Orange, New Jersey 07018-2012
    United States

    Site Not Available

  • Albuquerque Clinical Trials Inc - Clinedge - PPDS

    Albuquerque, New Mexico 87102-2619
    United States

    Active - Recruiting

  • MedPharmics, LLC. - Albuquerque - Platinum - PPDS

    Albuquerque, New Mexico 87102-3644
    United States

    Site Not Available

  • Velocity Clinical Research -Albuquerque -PPDS

    Albuquerque, New Mexico 87102-3644
    United States

    Active - Recruiting

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

    Binghamton, New York 13901-1046
    United States

    Active - Recruiting

  • Rochester Clinical Research, Inc

    Rochester, New York 14609-3173
    United States

    Active - Recruiting

  • Stony Brook University Medical Center

    Stony Brook, New York 11794-0001
    United States

    Active - Recruiting

  • Child Healthcare Associates - East Syracuse

    Syracuse, New York 13210-2306
    United States

    Site Not Available

  • OnSite Clinical Solutions, LLC - ClinEdge - PPDS

    Charlotte, North Carolina 28277-4859
    United States

    Active - Recruiting

  • Lucas Research - Morehead City - HyperCore - PPDS

    Morehead City, North Carolina 28557-3126
    United States

    Site Not Available

  • Tekton Research - Oklahoma- PPDS

    Edmond, Oklahoma 73013
    United States

    Active - Recruiting

  • Lynn Institute of Norman - ERN - PPDS

    Norman, Oklahoma 73072-3251
    United States

    Active - Recruiting

  • Velocity Clinical Research - Medford - PPDS

    Medford, Oregon 97504-7738
    United States

    Active - Recruiting

  • Coastal Carolina Research Center - PPDS

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Meharry Medical College

    Nashville, Tennessee 37208
    United States

    Active - Recruiting

  • Tekton Research - Texas - PPDS

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Tekton Research - Beaumont - Platinum - PPDS

    Beaumont, Texas 77706-3061
    United States

    Active - Recruiting

  • 3rd Coast Research Associates

    Corpus Christi, Texas 78414-4106
    United States

    Site Not Available

  • South Texas Clinical Research

    Corpus Christi, Texas 78404
    United States

    Site Not Available

  • BRCR Global Texas

    Edinburg, Texas 78539
    United States

    Site Not Available

  • Benchmark Research - Fort Worth - HyperCore -PPDS

    Fort Worth, Texas 76135
    United States

    Active - Recruiting

  • University of Texas Medical Branch (UTMB)

    Galveston, Texas 77550
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston, Texas 77030-3411
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    Houston, Texas 77043-2737
    United States

    Site Not Available

  • Bipharma Informatic -Cardiff Avenue - PPDS

    Houston, Texas 77084
    United States

    Site Not Available

  • West Houston Clinical Research - Hunt - PPDS

    Houston, Texas 77055-1626
    United States

    Active - Recruiting

  • Victoria Clinical Research Group

    Port Lavaca, Texas 77979
    United States

    Active - Recruiting

  • Benchmark Research - San Angelo - HyperCore - PPDS

    San Angelo, Texas 76904
    United States

    Active - Recruiting

  • Tekton Research - Texas - Platinum - PPDS

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • DM Clinical Research - ERN- PPDS

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • Crossroads Clinical Research (Victoria)

    Victoria, Texas 77901
    United States

    Active - Recruiting

  • JBR Clinical Research - CenExel JBR - PPDS

    Salt Lake City, Utah 84107-4536
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC - Norfolk

    Norfolk, Virginia 23502-3932
    United States

    Site Not Available

  • MultiCare Institute for Research and Innovation

    Spokane, Washington 99204-2803
    United States

    Active - Recruiting

  • University Of Wisconsin - Madison

    Madison, Wisconsin 53792-0001
    United States

    Site Not Available

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