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

August 21, 2025 updated by: ModernaTX, Inc.

A Phase 1/2, Randomized, Observer-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety and Immunogenicity of Heptavalent mRNA-1975 (SR1-7) and Monovalent mRNA-1982 (SR1) in Parallel Against Lyme Disease in Healthy Participants 18 Through 70 Years of Age

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

807

Phase

  • Phase 2
  • Phase 1

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

  • United States
    • Connecticut
      • Milford, Connecticut, United States, 06460
        • Clinical Research Consulting, LLC
      • Stamford, Connecticut, United States, 06905
        • Stamford Therapeutics Consortium
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Encore Research Group-Jacksonville Center for Clinical Research
      • Lake Mary, Florida, United States, 32746
        • University Clinical Research-DeLand, LLC d/b/a Accel Research Sites
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Atlanta, headlands LLC
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Johnson County Clin-Trials, Inc. (JCCT)
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Centennial Medical Group
      • Rockville, Maryland, United States, 20850
        • Advanced Primary and Geriatric Care
    • Massachusetts
      • Brookline, Massachusetts, United States, 02445
        • DM Clinical Research - Brookline
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute, Inc.
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Meridian Clinical Research - Omaha
    • New Hampshire
      • Newington, New Hampshire, United States, 03801
        • ActivMed Research LLC
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
    • Pennsylvania
      • Hatboro, Pennsylvania, United States, 19040
        • Hatboro Medical Associates/CCT Research
    • Rhode Island
      • Providence, Rhode Island, United States, 02886
        • Velocity Clinical Research Providence
    • Texas
      • Fort Worth, Texas, United States, 76135
        • Benchmark Research
      • Tomball, Texas, United States, 77375
        • DM Clinical Research
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research Center, LLC

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

Inclusion Criteria:

  • Body mass index of 18 to 39 kilograms/square meter (inclusive) at the Screening Visit.
  • Participants of nonchildbearing potential may be enrolled in the study.
  • For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy during the study intervention period, and agreement to continue adequate contraception or abstinence through 3 months following last study injection.

Exclusion Criteria:

  • 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.
  • Had previous vaccination against Lyme disease or participated in the past in any vaccine 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 (for example, tattoos; psoriasis patches affecting skin over the deltoid areas).
  • Received systemic immunosuppressants for >14 days in total within 180 days prior to the Screening Visit (for corticosteroids, ≥10 milligrams/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study.
  • History of myocarditis, pericarditis, or myopericarditis regardless of the timing of past medical history.
  • History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine or intervention that includes one or more of the same components contained in the study injection.
  • Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, infliximab) or blood products within 90 days prior to the Screening Visit or plans to receive them during the study.

Note: Other inclusion and exclusion criteria may apply.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mRNA-1975: Dose 1
Participants will receive 3 intramuscular (IM) injections of the mRNA-1975 vaccine at Dose Level 1 on Days 1, 57, and 169.
Biological: mRNA-1975
Dispersion delivered IM
Other Names:
  • SR1-7
Experimental: mRNA-1975: Dose 2
Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 2 on Days 1, 57, and 169.
Biological: mRNA-1975
Dispersion delivered IM
Other Names:
  • SR1-7
Experimental: mRNA-1975: Dose 3
Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose Level 3 on Days 1, 57, and 169.
Biological: mRNA-1975
Dispersion delivered IM
Other Names:
  • SR1-7
Experimental: mRNA-1975: Dose 4
Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 4 on Days 1, 57, and 169.
Biological: mRNA-1975
Dispersion delivered IM
Other Names:
  • SR1-7
Experimental: mRNA-1982: Dose 1
Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 1 on Days 1, 57, and 169.
Biological: mRNA-1982
Dispersion delivered IM
Other Names:
  • SR1
Experimental: mRNA-1982: Dose 2
Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 2 on Days 1, 57, and 169.
Biological: mRNA-1982
Dispersion delivered IM
Other Names:
  • SR1
Experimental: mRNA-1982: Dose 3
Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose level 3 on Days 1, 57, and 169.
Biological: mRNA-1982
Dispersion delivered IM
Other Names:
  • SR1
Placebo Comparator: Placebo
Participants will receive 3 IM injections of vaccine-matching placebo on Days 1, 57, and 169.
Biological: Placebo
Solution delivered IM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame: Up to Day 175 (7 days after each study injection)
Up to Day 175 (7 days after each study injection)
Number of Participants With Unsolicited Adverse Events (AEs)
Time Frame: Up to Day 196 (28 days after each study injection)
Up to Day 196 (28 days after each study injection)
Number of Participants With Medically Attended AEs
Time Frame: Day 1 through Day 337 (6 months after the last study injection)
Day 1 through Day 337 (6 months after the last study injection)
Number of Participants with AEs of Special Interest, Serious AEs, and AEs Leading to Discontinuation of Study Injection or Study Participation
Time Frame: Day 1 through Day 505 (End of Study)
Day 1 through Day 505 (End of Study)

Secondary Outcome Measures

Outcome Measure
Time Frame
Geometric Mean Concentration of Anti-outer Surface Protein A (anti-OspA) Binding Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay or a Similar Method
Time Frame: Days 1, 29, 85, and 197
Days 1, 29, 85, and 197
Geometric Mean Fold Rise of anti-OspA Binding IgG Antibody Concentration at Days 29, 85, and 197 Compared to Day 1 (Baseline)
Time Frame: Days 29, 85, and 197
Days 29, 85, and 197

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)

July 26, 2023

Primary Completion (Actual)

May 30, 2025

Study Completion (Actual)

May 30, 2025

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 21, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mRNA-1975/1982-P101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Lyme Disease

Clinical Trials on mRNA-1975

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe