A Phase 2 interventional study of mRNA-1982 and Placebo in Lyme Disease, sponsored by ModernaTX, Inc.. Active, not recruiting at 8 sites in Canada. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by ModernaTX, Inc. · Phase 2, Interventional, and Prevention
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.
91 studies on the registry are indexed under Lyme Disease; 27 are open to participants now.
This study's enrollment of 366 is above the median of 100 across 49 interventional studies indexed under Lyme Disease.
Browse Lyme Disease studies →ModernaTX, Inc. is the lead sponsor of 112 studies on the registry; 14 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 32 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Additional inclusion/exclusion criteria may apply, per protocol.
Participants will receive mRNA-1982 or placebo as an intramuscular injection.
Biological: mRNA-1982 · Biological: Placebo
Participants will receive mRNA-1982 (as a booster) or placebo as an intramuscular injection.
Biological: mRNA-1982 · Biological: Placebo
Suspension for injection
Suspension for injection
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
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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ModernaTX, Inc.