This clinical study will evaluate the safety, reactogenicity, and immunogenicity of monovalent mRNA-1982, a messenger ribonucleic acid (mRNA) vaccine to prevent Lyme disease in healthy adults aged 18 to 70 years old.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
366
Colchester Research Group
Truro, Nova Scotia, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, Canada
Stouffville Medical Research Institute Inc.
Stouffville, Ontario, Canada
Dr. Anil K. Gupta Medicine Professional Corporation Inc.
Both Phases: Number of Participants with Solicited Local and Systemic Adverse Reactions
Time frame: Day 1 up to Day 7 (7 days post-injection)
Both Phases: Number of Participants with Unsolicited Adverse Events
Time frame: Day 1 up to Day 28 (28 days post-injection)
Both Phases: Number of Participants with Medically Attended Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, and Adverse Events Leading to Discontinuation
Time frame: Day 1 up to Month 21 (End of study)
Dose-finding Phase: Geometric Mean Concentration (GMC) of Anti-outer Surface Protein A (OspA) Serotype 1 (ST1) Binding Immunoglobulin G (IgG) Antibodies (Ab)
Time frame: Days 1, 113, 197, 265, and 349
Dose-finding Phase: Geometric Mean Fold Rise (GMFR) of Anti-OspA ST1 Binding IgG Ab
Time frame: Days 113, 197, 265, and 349
Booster Phase: GMC of Anti-OspA ST1 Binding IgG Ab
Time frame: Days 1, 29, and 181 of Booster Phase
Booster Phase: GMFR of Anti-OspA ST1 Binding IgG Ab
Time frame: Days 29 and 181 of Booster Phase
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