ACTIVE_NOT_RECRUITING

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

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Conditions

CytomegalovirusmRNA-1647 VaccineCMVModerna

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-11-07
Study Completion:2027-01-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05575492

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:9 Years to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Is in good general health, in the opinion of the Investigator, and is capable of complying with study procedures.
  3. * For the CMV-seronegative cohorts: At the Screening visit, is CMV IgG-negative and CMV immunoglobulin M (IgM)-negative.
  4. * 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.
  5. * 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).
  6. * 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.
  1. * 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.
  2. * Has received, or plans to receive, any nonstudy vaccine \< 28 days prior to or after any study injection.
  3. * Has a screening liver function test (aspartate aminotransferase, alanine aminotransferase, total bilirubin) or a screening creatinine result of Toxicity Grade ≥1.
  4. * Has a Screening hematology or coagulation result of Toxicity Grade ≥1.
  5. * Is acutely ill or febrile (body temperature ≥38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) at the Screening Visit.
  6. * 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).
  7. * 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.
  8. * Reports a history of myocarditis, pericarditis, or myopericarditis.
  9. * 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.
  10. * Has previously received an investigational CMV vaccine.
  11. * Has received systemic immunoglobulins or blood products \<3 months prior to the day of the first study injection (Day 1).
  12. * Has donated ≥ 450 milliliter (mL) of blood products \<28 days prior to the day of the first study injection (Day 1).
  13. * 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.

Contacts and Locations

Study Locations (Sites)

Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
La Mesa, California, 91942-3189
United States
Velocity Clinical Research - San Diego - PPDS
La Mesa, California, 91942
United States
Benchmark Research - Sacramento -Hypercore- PPDS
Sacramento, California, 95864
United States
Tekton Research - Fort Collins - Platinum - PPDS
Fort Collins, Colorado, 80525-5752
United States
Velocity Clinical Research (Washington)- PPDS
Washington D.C., District of Columbia, 20016
United States
Prohealth Research Center
Doral, Florida, 33166-6613
United States
University of Florida Jacksonville
Jacksonville, Florida, 32209
United States
Clinical Neuroscience Solutions Inc (Jacksonville-Belfort Rd)
Jacksonville, Florida, 32256-6040
United States
Clinical Neurosciences Solutions Inc. (Orlando-East South St)
Orlando, Florida, 32801-2987
United States
Palm Harbor Dermatology
Tampa, Florida, 33609-2230
United States
Santos Research Center
Tampa, Florida, 33615-3219
United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322-1014
United States
Centricity Research Roswell
Columbus, Georgia, 31904-8946
United States
iResearch Atlanta - CenExel - PPDS
Decatur, Georgia, 30030-3438
United States
Clinical Research Prime - ClinEdge - PPDS
Idaho Falls, Idaho, 83404-5305
United States
Benchmark Research - Covington - HyperCore- PPDS
Covington, Louisiana, 70433
United States
Tulane Medical Center
New Orleans, Louisiana, 70112-2632
United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201-1509
United States
The Pediatric Centre
Columbia, Maryland, 21045
United States
The Pediatric Centre of Frederick
Frederick, Maryland, 21702
United States
Wayne State University
Detroit, Michigan, 48201
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Velocity Clinical Research - Gulfport
Gulfport, Mississippi, 39503
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
Albuquerque Clinical Trials Inc - Clinedge - PPDS
Albuquerque, New Mexico, 87102-2619
United States
Velocity Clinical Research -Albuquerque -PPDS
Albuquerque, New Mexico, 87102-3644
United States
Velocity Clinical Research (Binghamton - New York) - PPDS
Binghamton, New York, 13901-1046
United States
Rochester Clinical Research, Inc
Rochester, New York, 14609-3173
United States
OnSite Clinical Solutions, LLC - ClinEdge - PPDS
Charlotte, North Carolina, 28277-4859
United States
Tekton Research - Oklahoma- PPDS
Edmond, Oklahoma, 73013
United States
Lynn Institute of Norman - ERN - PPDS
Norman, Oklahoma, 73072-3251
United States
Velocity Clinical Research - Medford - PPDS
Medford, Oregon, 97504-7738
United States
Meharry Medical College
Nashville, Tennessee, 37208
United States
Tekton Research - Texas - PPDS
Austin, Texas, 78705
United States
Tekton Research - Beaumont - Platinum - PPDS
Beaumont, Texas, 77706-3061
United States
Benchmark Research - Fort Worth - HyperCore -PPDS
Fort Worth, Texas, 76135
United States
University of Texas Medical Branch (UTMB)
Galveston, Texas, 77550
United States
West Houston Clinical Research - Hunt - PPDS
Houston, Texas, 77055-1626
United States
Victoria Clinical Research Group
Port Lavaca, Texas, 77979
United States
Benchmark Research - San Angelo - HyperCore - PPDS
San Angelo, Texas, 76904
United States
Tekton Research - Texas - Platinum - PPDS
San Antonio, Texas, 78229
United States
DM Clinical Research - ERN- PPDS
Tomball, Texas, 77375
United States
Crossroads Clinical Research (Victoria)
Victoria, Texas, 77901
United States
JBR Clinical Research - CenExel JBR - PPDS
Salt Lake City, Utah, 84107-4536
United States
MultiCare Institute for Research and Innovation
Spokane, Washington, 99204-2803
United States

Collaborators and Investigators

Sponsor: ModernaTX, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-07
Study Completion Date2027-01-15

Study Record Updates

Study Start Date2022-11-07
Study Completion Date2027-01-15

Terms related to this study

Keywords Provided by Researchers

  • mRNA-1647 Vaccine
  • CMV
  • Moderna

Additional Relevant MeSH Terms

  • Cytomegalovirus