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
Lyme Disease
About this trial
This is an interventional treatment trial for Lyme Disease focused on measuring mRNA-1975, mRNA-1982, Vaccine, Lyme Disease Vaccine, Messenger RNA, Moderna
Eligibility Criteria
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.
Sites / Locations
- Clinical Research Consulting, LLCRecruiting
- Stamford Therapeutics ConsortiumRecruiting
- Chase Medical Research, LLC
- Jacksonville Center for Clinical ResearchRecruiting
- University Clinical Research-DeLand, LLC d/b/a Accel Research SitesRecruiting
- Clinical Research Atlanta, headlands LLC
- Johnson County Clin-Trials, Inc. (JCCT)
- Centennial Medical Group
- Advanced Primary and Geriatric Care
- DM Clinical Research - Brookline
- Clinical Research Institute, Inc.
- Velocity Clinical Research Providence
- ActivMed Research LLC
- Rochester Clinical Research, Inc.
- Lynn Health Science Institute
- Hatboro Medical Associates/CCT Research
- Velocity Clinical Research Providence
- Benchmark Research
- DM Clinical ResearchRecruiting
- Charlottesville Medical Research Center, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
mRNA-1975: Dose 1
mRNA-1975: Dose 2
mRNA-1975: Dose 3
mRNA-1975: Dose 4
mRNA-1982: Dose 1
mRNA-1982: Dose 2
mRNA-1982: Dose 3
Placebo
Participants will receive 3 intramuscular (IM) injections of the mRNA-1975 vaccine at Dose Level 1 on Days 1, 57, and 169.
Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 2 on Days 1, 57, and 169.
Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose Level 3 on Days 1, 57, and 169.
Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 4 on Days 1, 57, and 169.
Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 1 on Days 1, 57, and 169.
Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 2 on Days 1, 57, and 169.
Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose level 3 on Days 1, 57, and 169.
Participants will receive 3 IM injections of vaccine-matching placebo on Days 1, 57, and 169.