A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982 to Prevent Lyme Disease in Healthy Participants (18 to 70 Years of Age)

Sponsor
ModernaTX, Inc.
Study ID
NCT07561294
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • mRNA-1982 — BIOLOGICAL
    Suspension for injection
  • Placebo — BIOLOGICAL
    Suspension for injection

Study Details

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.

Key Dates

Start date
Apr 29, 2026
Status verified
May 2026
Primary completion
Nov 9, 2028
Completion
Nov 9, 2028

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Dose-finding Phase
    Participants will receive mRNA-1982 or placebo as an intramuscular injection.
  • Experimental: Booster Phase
    Participants will receive mRNA-1982 (as a booster) or placebo as an intramuscular injection.

Primary Outcome Measure

Both Phases: Number of Participants with Solicited Local and Systemic Adverse Reactions [ Time Frame: Day 1 up to Day 7 (7 days post-injection) ]

Central Contacts

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