A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age
- Registration Number
- NCT05575492
- Lead Sponsor
- ModernaTX, Inc.
- Brief 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.
- Detailed Description
The study will be conducted in 2 parts: Part 1 Dose-Ranging and Part 2 Safety Expansion.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 770
- 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 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description mRNA-1647 Dose B mRNA-1647 CMV-seronegative or CMV-seropositive participants 9 to 15 years of age will receive mRNA-1647 at Dose Level B by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6. Dose Expansion: Placebo Placebo Participants will receive placebo by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6. mRNA-1647 Dose A mRNA-1647 CMV-seronegative or CMV-seropositive participants 9 to 15 years of age will receive mRNA-1647 at Dose Level A by intramuscular (IM) injection given as a 3-injection series on Day 1, Month 2, and Month 6. mRNA-1647 Dose C mRNA-1647 CMV-seronegative or CMV-seropositive participants 9 to 15 years of age and 16 to 25 years of age will receive mRNA-1647 at Dose Level C by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6. Dose Expansion: mRNA-1647 mRNA-1647 CMV-seronegative or CMV-seropositive participants 9 to 15 years of age will receive mRNA-1647 at selected dose level by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6.
- Primary Outcome Measures
Name Time Method Number of Participants with ≥2-Fold, 3-Fold, and 4-Fold increases Over Baseline of Anti-CMV Antibodies Up to Day 527 (end of study) Serum functional antibody levels against vaccine antigens will be measured by nAb titer against epithelial cell infection and nAb titer against fibroblast infection.
Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Up to Day 176 (7 days after each study injection) Number of Medically Attended Adverse Events (MAAEs) Up to Day 347 (6 months after the last study injection) Geometric Mean Titer (GMT) of Anti-CMV Neutralizing Antibodies (nAbs) Up to Day 527 (end of study) Serum functional antibody levels against vaccine antigens will be measured by nAb titer against epithelial cell infection and nAb titer against fibroblast infection.
Geometric Mean Fold-Rise (GMFR) of Anti-CMV nAbs Up to Day 527 (end of study) Serum functional antibody levels against vaccine antigens will be measured by nAb titer against epithelial cell infection and nAb titer against fibroblast infection.
Number of Unsolicited Adverse Events (AEs) Up to Day 197 (28 days after each study injection) Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation Up to Day 527 (end of study)
- Secondary Outcome Measures
Name Time Method Number of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases Over Baseline of Binding Anti-gB and Anti-pentamer Specific IgG Up to Day 527 (end of study) Serum antigen-specific binding antibody titers against vaccine antigens will be measured by ELISA specific to the gB and pentamer proteins.
Geometric Mean Concentration (GMC) of Binding Anti-Glycoprotein B (gB) Specific Immunoglobulin G (IgG) and Anti-Pentamer Specific IgG Up to Day 527 (end of study) Serum antigen-specific binding antibody titers against vaccine antigens will be measured by enzyme-linked immunosorbent assay (ELISA) specific to the gB and pentamer proteins.
GMFR of Binding Anti-gB and Anti-pentamer Specific IgG Up to Day 527 (end of study) Serum antigen-specific binding antibody concentrations against vaccine antigens will be measured by ELISA specific to the gB and pentamer proteins.
Trial Locations
- Locations (71)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
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, District of Columbia, United States
Prohealth Research Center
🇺🇸Doral, Florida, United States
University of Florida Jacksonville
🇺🇸Jacksonville, Florida, United States
Clinical Neuroscience Solutions Inc (Jacksonville-Belfort Rd)
🇺🇸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
Tekton Research - Georgia - Platinum - PPDS
🇺🇸Chamblee, Georgia, United States
Centricity Research Roswell
🇺🇸Columbus, 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
Stony Brook University Medical Center
🇺🇸Stony Brook, 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
Coastal Carolina Research Center - PPDS
🇺🇸North Charleston, South Carolina, 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
South Texas Clinical Research
🇺🇸Corpus Christi, Texas, United States
BRCR Global Texas
🇺🇸Edinburg, Texas, United States
Benchmark Research - Fort Worth - HyperCore -PPDS
🇺🇸Fort Worth, Texas, United States
University of Texas Medical Branch (UTMB)
🇺🇸Galveston, Texas, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
West Houston Clinical Research - Hunt - PPDS
🇺🇸Houston, Texas, United States
Bipharma Informatic -Cardiff Avenue - 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
Alliance for Multispecialty Research, LLC - Norfolk
🇺🇸Norfolk, Virginia, United States
MultiCare Institute for Research and Innovation
🇺🇸Spokane, Washington, 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
Addenbrooke's Hospital
🇬🇧Cambridge, Cambridgeshire, United Kingdom
Southampton General Hospital
🇬🇧Southampton, Hampshire, United Kingdom
Manchester Royal Infirmary - PPDS
🇬🇧Manchester, Lancashire, 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