The main purpose of the study is to evaluate the efficacy and safety of mRNA-1647 compared to placebo to prevent first clinically significant cytomegalovirus infection (CS-CMVi) in the period following cessation of CMV prophylactic treatment (for example, letermovir) on Day 100 post-HCT through Month 9 post-HCT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
84
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Time to the First Occurrence of an CS-CMVi Event as Measured by initiation of anti-CMV Antiviral Therapy
Time frame: Day 100 to Month 9
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time frame: Up to Day 187 (7 days after last study injection)
Number of Unsolicited Adverse Events (AEs)
Time frame: Up to Day 205 (25 days after last study injection)
Number of Participants with Severe AEs
Time frame: Up to Day 365
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to Day 365
Number of Participants with Grade ≥3 Acute Graft-Versus-Host Disease (GVHD)
Time frame: Up to Day 365
Number of Participants with First Occurrence of All CS-CMVi Events as Measured by Initiation of Anti-CMV Antiviral and/or End-Organ Disease
Time frame: Day 100 to Month 9
Number of Participants with an Occurrence of CMV Viremia
CMV Viremia is defined as ≥300 international units/milliliters (IU/mL).
Time frame: Day 100 to Month 9
Number of Participants with CMV End-Organ Disease
Time frame: Day 100 to Month 9
Duration of CMV Viremia
Time frame: Day 100 to Month 9
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Duration of CMV Treatment
Time frame: Day 100 to Month 9
Number of Participants with Non-Relapse Mortality at 9 Months Post-HCT.
Time frame: Month 9
Titer of CMV-Specific Neutralizing Antibody (nAb)
Time frame: Days 42, 67, 92, 117, 180, 205 and 270
Geometric Mean Titer (GMT) of Anti-gB-Specific Immunoglobulin G (IgG) and Anti-Pentamer-Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Time frame: Days 42, 67, 92, 117, 180, 205 and 270
Geometric Mean Concentration (GMC) of Anti-gB-Specific Immunoglobulin G (IgG) and Anti-Pentamer-Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Time frame: Days 42, 67, 92, 117, 180, 205 and 270
Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline GMTs or GMCs
Time frame: Days 42, 67, 92, 117, 180, 205 and 270