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
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Lyme Disease
In brief
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.
Key facts
- Study ID
- NCT05975099
- Run by
- ModernaTX, Inc.
- People needed
- 807
- Starts
- 2023-07-26
- Expected to finish
- 2025-05-30
- Last updated by the study team
- 2026-07-30
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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