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
Key facts
- Who runs it
- ModernaTX, Inc.
- Where
- Brookline, Charlottesville, Columbia, Fort Worth, Hatboro, Jacksonville, Lake Mary, Lenexa, Milford, Minneapolis, Newington, Oklahoma City, Omaha, Providence, Rochester, Rockville, Stamford, Stockbridge, Tomball, and Waterbury, United StatesSee the 20 sites
- Trial code
- Status
- Completed
- Phase
- Phase 1/2
- People taking part
- 807 people enrolled
- Started
- 26 Jul 2023
- Ended
- 30 May 2025
- Type of study
- Interventional, 8 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- mRNA-1975
- mRNA-1982
- Placebo
- Record updated
- 30 July 2026
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- 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
- Have chronic illness related to Lyme disease or an active symptomatic Lyme disease infection as suspected or diagnosed by a physician
- Dermatologic conditions that could affect local solicited AR assessments (for example, tattoos; psoriasis patches affecting skin over the deltoid areas)
- 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
Where in United States
- DM Clinical Research - BrooklineBrookline, United States
- Charlottesville Medical Research Center, LLCCharlottesville, United States
- Centennial Medical GroupColumbia, United States
- Benchmark ResearchFort Worth, United States
- Hatboro Medical Associates/CCT ResearchHatboro, United States
- Encore Research Group- Jacksonville Center for Clinical ResearchJacksonville, United States
- University Clinical Research-DeLand, LLC d/b/a Accel Research SitesLake Mary, United States
- Johnson County Clin-Trials, Inc. (JCCT)Lenexa, United States
- Clinical Research Consulting, LLCMilford, United States
- Clinical Research Institute, Inc.Minneapolis, United States
- ActivMed Research LLCNewington, United States
- Lynn Health Science InstituteOklahoma City, United States
- Meridian Clinical Research - OmahaOmaha, United States
- Velocity Clinical Research, ProvidenceProvidence, United States
- Rochester Clinical Research, IncRochester, United States
- Advanced Primary and Geriatric CareRockville, United States
- Stamford Therapeutics ConsortiumStamford, United States
- Clinical Research Atlanta, headlands LLCStockbridge, United States
- DM Clinical ResearchTomball, United States
- Chase Medical Research, LLCWaterbury, United States
About the trial
What the trial wants to find out
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.
The 8 groups in the trial
- mRNA-1975: Dose 1Treatment being tested
Participants will receive 3 intramuscular (IM) injections of the mRNA-1975 vaccine at Dose Level 1 on Days 1, 57, and 169.
Treatment: mRNA-1975
- mRNA-1975: Dose 2Treatment being tested
Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 2 on Days 1, 57, and 169.
Treatment: mRNA-1975
- mRNA-1975: Dose 3Treatment being tested
Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose Level 3 on Days 1, 57, and 169.
Treatment: mRNA-1975
- mRNA-1975: Dose 4Treatment being tested
Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 4 on Days 1, 57, and 169.
Treatment: mRNA-1975
- mRNA-1982: Dose 1Treatment being tested
Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 1 on Days 1, 57, and 169.
Treatment: mRNA-1982
- mRNA-1982: Dose 2Treatment being tested
Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 2 on Days 1, 57, and 169.
Treatment: mRNA-1982
- mRNA-1982: Dose 3Treatment being tested
Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose level 3 on Days 1, 57, and 169.
Treatment: mRNA-1982
- PlaceboPlacebo, for comparison
Participants will receive 3 IM injections of vaccine-matching placebo on Days 1, 57, and 169.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Publications
- Record updated
- 30 July 2026