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
NCT ID: NCT05975099
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
807 participants
INTERVENTIONAL
2023-07-26
2025-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
mRNA-1975
Dispersion delivered IM
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.
mRNA-1975
Dispersion delivered IM
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.
mRNA-1975
Dispersion delivered IM
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.
mRNA-1975
Dispersion delivered IM
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.
mRNA-1982
Dispersion delivered IM
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.
mRNA-1982
Dispersion delivered IM
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.
mRNA-1982
Dispersion delivered IM
Placebo
Participants will receive 3 IM injections of vaccine-matching placebo on Days 1, 57, and 169.
Placebo
Solution delivered IM
Interventions
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mRNA-1975
Dispersion delivered IM
mRNA-1982
Dispersion delivered IM
Placebo
Solution delivered IM
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Research Consulting, LLC
Milford, Connecticut, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Encore Research Group-Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
University Clinical Research-DeLand, LLC d/b/a Accel Research Sites
Lake Mary, Florida, United States
Clinical Research Atlanta, headlands LLC
Stockbridge, Georgia, United States
Johnson County Clin-Trials, Inc. (JCCT)
Lenexa, Kansas, United States
Centennial Medical Group
Columbia, Maryland, United States
Advanced Primary and Geriatric Care
Rockville, Maryland, United States
DM Clinical Research - Brookline
Brookline, Massachusetts, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States
Meridian Clinical Research - Omaha
Omaha, Nebraska, United States
ActivMed Research LLC
Newington, New Hampshire, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Hatboro Medical Associates/CCT Research
Hatboro, Pennsylvania, United States
Velocity Clinical Research Providence
Providence, Rhode Island, United States
Benchmark Research
Fort Worth, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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mRNA-1975/1982-P101
Identifier Type: -
Identifier Source: org_study_id
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