A Study to Evaluate the Safety and Immunogenicity of mRNA-1975 and mRNA-1982 Against Lyme Disease in Participants 18 Through 70 Years of Age

Last updated: March 3, 2025
Sponsor: ModernaTX, Inc.
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Rash

Lyme Disease

Treatment

mRNA-1982

Placebo

mRNA-1975

Clinical Study ID

NCT05975099
mRNA-1975/1982-P101
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the safety and immunogenicity in parallel of heptavalent mRNA-1975 and monovalent mRNA-1982 against Lyme disease in healthy adult participants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body mass index of 18 to 39 kilograms/square meter (inclusive) at the ScreeningVisit.

  • Participants of nonchildbearing potential may be enrolled in the study.

  • For female participants of childbearing potential: negative pregnancy test, adequatecontraception or has abstained from all activities that could result in pregnancyduring the study intervention period, and agreement to continue adequatecontraception or abstinence through 3 months following last study injection.

Exclusion

Exclusion Criteria:

  • Have chronic illness related to Lyme disease or an active symptomatic Lyme diseaseinfection as suspected or diagnosed by a physician.

  • Received treatment for Lyme disease within the prior 3 months.

  • Had previous vaccination against Lyme disease or participated in the past in anyvaccine study for Lyme disease.

  • Had a tick bite within 4 weeks prior to the study injection visit.

  • Dermatologic conditions that could affect local solicited AR assessments (forexample, tattoos; psoriasis patches affecting skin over the deltoid areas).

  • Received systemic immunosuppressants for >14 days in total within 180 days prior tothe Screening Visit (for corticosteroids, ≥10 milligrams/day of prednisone orequivalent) or is anticipating the need for systemic immunosuppressive treatment atany time during participation in the study.

  • History of myocarditis, pericarditis, or myopericarditis regardless of the timing ofpast medical history.

  • History of anaphylaxis, urticaria, or other significant adverse reaction requiringmedical intervention after receipt of a vaccine or intervention that includes one ormore of the same components contained in the study injection.

  • Has received systemic immunoglobulins, long-acting biological therapies that affectimmune responses (for example, infliximab) or blood products within 90 days prior tothe Screening Visit or plans to receive them during the study.

Note: Other inclusion and exclusion criteria may apply.

Study Design

Total Participants: 807
Treatment Group(s): 3
Primary Treatment: mRNA-1982
Phase: 1/2
Study Start date:
July 26, 2023
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Clinical Research Consulting, LLC

    Milford, Connecticut 06460
    United States

    Site Not Available

  • Stamford Therapeutics Consortium

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Chase Medical Research, LLC

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Encore Research Group-Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • University Clinical Research-DeLand, LLC d/b/a Accel Research Sites

    Lake Mary, Florida 32746
    United States

    Site Not Available

  • Clinical Research Atlanta, headlands LLC

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Johnson County Clin-Trials, Inc. (JCCT)

    Lenexa, Kansas 66219
    United States

    Site Not Available

  • Centennial Medical Group

    Columbia, Maryland 21045
    United States

    Site Not Available

  • Centennial Medical Group

    Elkridge, Maryland 21075
    United States

    Site Not Available

  • Advanced Primary and Geriatric Care

    Rockville, Maryland 20850
    United States

    Site Not Available

  • DM Clinical Research - Brookline

    Brookline, Massachusetts 02445
    United States

    Site Not Available

  • Clinical Research Institute, Inc.

    Minneapolis, Minnesota 55402
    United States

    Site Not Available

  • Meridian Clinical Research - Omaha

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • Velocity Clinical Research Providence

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • ActivMed Research LLC

    Newington, New Hampshire 03801
    United States

    Site Not Available

  • ActivMed Research LLC

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Rochester Clinical Research, Inc.

    Rochester, New York 14609
    United States

    Site Not Available

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Hatboro Medical Associates/CCT Research

    Hatboro, Pennsylvania 19040
    United States

    Site Not Available

  • Velocity Clinical Research Providence

    East Greenwich, Rhode Island 02818
    United States

    Site Not Available

  • Velocity Clinical Research Providence

    Providence, Rhode Island 02886
    United States

    Site Not Available

  • Benchmark Research

    Fort Worth, Texas 76135
    United States

    Site Not Available

  • DM Clinical Research

    Tomball, Texas 77375
    United States

    Site Not Available

  • Charlottesville Medical Research Center, LLC

    Charlottesville, Virginia 22911
    United States

    Site Not Available

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