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ACTIVE NOT RECRUITING

NCT05575492

PHASE1/PHASE2

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

Sponsor: ModernaTX, Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase 1/2a Open-Label Dose-Ranging and Observer-Blind Placebo-Controlled, Safety and Immunogenicity Study of mRNA-1647 Cytomegalovirus Vaccine in Female and Male Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age

Key Details

Gender

All

Age Range

9 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

873

Start Date

2022-11-07

Completion Date

2027-01-15

Last Updated

2025-12-15

Healthy Volunteers

Yes

Conditions

Cytomegalovirus

Interventions

BIOLOGICAL

mRNA-1647

Sterile liquid for injection

OTHER

Placebo

0.9% sodium chloride injection (normal saline)

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.

Locations (57)

Paradigm Clinical Research Institute Inc - ClinEdge - PPDS

La Mesa, California, United States

Velocity Clinical Research - San Diego - PPDS

La Mesa, California, United States

Benchmark Research - Sacramento -Hypercore- PPDS

Sacramento, California, United States

Tekton Research - Fort Collins - Platinum - PPDS

Fort Collins, Colorado, United States

Velocity Clinical Research (Washington)- PPDS

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

Prohealth Research Center

Doral, Florida, United States

University of Florida Jacksonville

Jacksonville, Florida, United States

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

Orlando, Florida, United States

Palm Harbor Dermatology

Tampa, Florida, United States

Santos Research Center

Tampa, Florida, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

iResearch Atlanta - CenExel - PPDS

Decatur, Georgia, United States

Clinical Research Prime - ClinEdge - PPDS

Idaho Falls, Idaho, United States

Benchmark Research - Covington - HyperCore- PPDS

Covington, Louisiana, United States

Tulane Medical Center

New Orleans, Louisiana, United States

University of Maryland School of Medicine

Baltimore, Maryland, United States

The Pediatric Centre

Columbia, Maryland, United States

The Pediatric Centre of Frederick

Frederick, Maryland, United States

Wayne State University

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Velocity Clinical Research - Gulfport

Gulfport, Mississippi, United States

Velocity Clinical Research (Lincoln-Nebraska) - PPDS

Lincoln, Nebraska, United States

Velocity Clinical Research (Norfolk - Nebraska) - PPDS

Norfolk, Nebraska, United States

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

Omaha, Nebraska, United States

Albuquerque Clinical Trials Inc - Clinedge - PPDS

Albuquerque, New Mexico, United States

Velocity Clinical Research -Albuquerque -PPDS

Albuquerque, New Mexico, United States

Velocity Clinical Research (Binghamton - New York) - PPDS

Binghamton, New York, United States

Rochester Clinical Research, Inc

Rochester, New York, United States

OnSite Clinical Solutions, LLC - ClinEdge - PPDS

Charlotte, North Carolina, United States

Tekton Research - Oklahoma- PPDS

Edmond, Oklahoma, United States

Lynn Institute of Norman - ERN - PPDS

Norman, Oklahoma, United States

Velocity Clinical Research - Medford - PPDS

Medford, Oregon, United States

Meharry Medical College

Nashville, Tennessee, United States

Tekton Research - Texas - PPDS

Austin, Texas, United States

Tekton Research - Beaumont - Platinum - PPDS

Beaumont, Texas, United States

Benchmark Research - Fort Worth - HyperCore -PPDS

Fort Worth, Texas, United States

University of Texas Medical Branch (UTMB)

Galveston, Texas, United States

West Houston Clinical Research - Hunt - PPDS

Houston, Texas, United States

Victoria Clinical Research Group

Port Lavaca, Texas, United States

Benchmark Research - San Angelo - HyperCore - PPDS

San Angelo, Texas, United States

Tekton Research - Texas - Platinum - PPDS

San Antonio, Texas, United States

DM Clinical Research - ERN- PPDS

Tomball, Texas, United States

Crossroads Clinical Research (Victoria)

Victoria, Texas, United States

JBR Clinical Research - CenExel JBR - PPDS

Salt Lake City, Utah, United States

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

Calgary, Alberta, Canada

ALTA Clinical Research Inc

Edmonton, Alberta, Canada

CARe Clinic

Red Deer, Alberta, Canada

Canadian Center for Vaccinology

Halifax, Nova Scotia, Canada

Hamilton Medical Research Group

Hamilton, Ontario, Canada

Bluewater Clinical Research Group

Sarnia, Ontario, Canada

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

Southampton General Hospital

Southampton, Hampshire, United Kingdom

Lakeside Healthcare

Corby, Northamptonshire, United Kingdom

Sheffield Children's Hospital

Sheffield, South Yorkshire, United Kingdom

Queen Elizabeth Hospital

Birmingham, United Kingdom

Noah's Ark Children's Hospital for Wales

Cardiff, United Kingdom

St. George Hospital

London, United Kingdom