RecruitingPhase 2NCT07561294

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)

A Phase 2, Randomized, Observer-blind, Dose-finding, Placebo-controlled Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982, an mRNA Vaccine to Prevent Lyme Disease in Healthy Adult Participants (18 to 70 Years of Age)


Sponsor

ModernaTX, Inc.

Enrollment

350 participants

Start Date

Apr 29, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria2

  • In good general health in the opinion of the investigator as determined by medical evaluation including medical history and physical examination at screening.
  • Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria5

  • History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic.
  • Have chronic illness related to Lyme disease or an active symptomatic Lyme disease infection as suspected or diagnosed by a physician.
  • Received treatment for Lyme disease within the prior 3 months.
  • Previously vaccinated against Lyme disease or participated in the past in any vaccine study for Lyme disease.
  • Had a tick bite within 4 weeks prior to Day 1.

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Interventions

BIOLOGICALmRNA-1982

Suspension for injection

BIOLOGICALPlacebo

Suspension for injection


Locations(8)

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.

Toronto, Ontario, Canada

Diex Recherche Inc. - Division Joliette

Joliette, Quebec, Canada

Diex Recherche Inc. - Division Sherbrooke

Sherbrooke, Quebec, Canada

Diex Recherche Inc. - Division Victoriaville

Victoriaville, Quebec, Canada

Diex Recherche Inc. - Division Quebec

Québec, Canada

View Full Details on ClinicalTrials.gov

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NCT07561294


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