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)

July 31, 2026 updated by: ModernaTX, Inc.

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)

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

366

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1V 4T3
        • Diex Recherche Inc. - Division Quebec
    • Nova Scotia
      • Truro, Nova Scotia, Canada, B2N 1L2
        • Colchester Research Group
    • Ontario
      • Sarnia, Ontario, Canada, N7T 4X3
        • Bluewater Clinical Research Group Inc.
      • Stouffville, Ontario, Canada, L4A 1H2
        • Stouffville Medical Research Institute Inc.
      • Toronto, Ontario, Canada, M9V 4B4
        • Dr. Anil K. Gupta Medicine Professional Corporation Inc.
    • Quebec
      • Joliette, Quebec, Canada, J6E 6A9
        • Diex Recherche Inc. - Division Joliette
      • Sherbrooke, Quebec, Canada, J1L 0H8
        • Diex Recherche Inc. - Division Sherbrooke
      • Victoriaville, Quebec, Canada, G6P 3Z8
        • Diex Recherche Inc. - Division Victoriaville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose-finding Phase
Participants will receive mRNA-1982 or placebo as an intramuscular injection.
Biological: mRNA-1982
Suspension for injection
Biological: Placebo
Suspension for injection
Experimental: Booster Phase
Participants will receive mRNA-1982 (as a booster) or placebo as an intramuscular injection.
Biological: mRNA-1982
Suspension for injection
Biological: Placebo
Suspension for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Both Phases: Number of Participants with Solicited Local and Systemic Adverse Reactions
Time Frame: Day 1 up to Day 7 (7 days post-injection)
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)
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)
Day 1 up to Month 21 (End of study)

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
Days 29 and 181 of Booster Phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModernaTX, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2026

Primary Completion (Estimated)

November 9, 2028

Study Completion (Estimated)

November 9, 2028

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

August 3, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mRNA-1982-P201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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