This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1647 and mRNA-1443 cytomegalovirus vaccines in healthy adults
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
181
Research Centers of America
Hollywood, Florida, United States
Advanced Clinical Research
Meridian, Idaho, United States
Optimal Research
Peoria, Illinois, United States
Johnson County Clinical Trials
Lenexa, Kansas, United States
Frequency of solicited AEs (local and systemic reactogenicity events)
Time frame: 7 days following each dose administration
Frequency of unsolicited adverse events
Time frame: 29 days following each dose administration
Frequency of medically-attended AEs, adverse events of special interest (AESI), and serious adverse events (SAE)
Time frame: one year following the last dose administration
Frequency of clinical laboratory adverse events
Time frame: 1 month following the last dose administration
Titers of anti-CMV neutralizing antibodies against epithelial cell infection measured by neutralization assay in comparison with baseline sample
Time frame: 6 months following the last dose administration
Titers of anti-CMV neutralizing antibodies against fibroblast cell infection measured by neutralization assay in comparison with baseline sample
Time frame: 6 months following the last dose administration
Titers of vaccine antigen-specific IgG antibodies as measured by ELISA assay in comparison with baseline sample
Time frame: 6 months following the last dose administration
Frequencies of vaccine antigen-specific CD4 and CD8 T cells secreting interferon gamma as determined by ELISPOT
Time frame: 6 months following the last dose administration
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