The main objective of this study is to evaluate the safety, reactogenicity, and immunogenicity of the mRNA-1647 vaccine administered according to a 3-study injection schedule in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive Japanese adults 18 to 40 years of age in the United States.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
9
Velocity Clinical Research
North Hollywood, California, United States
California Research Foundation
San Diego, California, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 176 (7 days after each injection)
Number of Participants With Unsolicited Adverse Events (AEs)
Time frame: Up to Day 197 (28 days after each injection)
Number of Participants With Medically-Attended AEs (MAAEs)
Time frame: Day 1 through 6 months after the last injection (up to Day 347)
Number of Participants With Serious AEs (SAEs)
Time frame: Day 1 through End of Study (EOS) (up to Day 347)
Number of Participants With AEs of Special Interest (AESIs)
Time frame: Day 1 through EOS (up to Day 347)
Geometric Mean Titer (GMT) of Serum Neutralizing Anti-CMV Antibodies (nAbs) Against Epithelial Cell Infection and Against Fibroblast Infection
Time frame: Days 1, 29, 85, 169, 197, and 347
Geometric Mean Fold-Rise (GMFR) of nAb Against Epithelial Cell Infection and Against Fibroblast Infection
Time frame: Days 29, 85, 169, 197, and 347
Proportion of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases in nAb over Baseline Against Epithelial Cell Infection and Against Fibroblast Infection
Time frame: Days 29, 85, 169, 197, and 347
GMT of Anti-Glycoprotein B (gB) Specific Immunoglobulin G (IgG) and Anti-Pentamer Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Time frame: Days 1, 29, 85, 169, 197, and 347
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GMFR of Anti-gB and Anti-Pentamer Specific IgG
Time frame: Days 29, 85, 169, 197, and 347
Proportion of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases Over Baseline in Anti-gB and Anti-Pentamer Specific IgG
Time frame: Days 29, 85, 169, 197, and 347