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
- Conditions
- Lyme Disease
- Interventions
- Registration Number
- NCT05975099
- Lead Sponsor
- ModernaTX, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 807
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mRNA-1975: Dose 4 mRNA-1975 Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 4 on Days 1, 57, and 169. mRNA-1982: Dose 3 mRNA-1982 Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose level 3 on Days 1, 57, and 169. mRNA-1975: Dose 1 mRNA-1975 Participants will receive 3 intramuscular (IM) injections of the mRNA-1975 vaccine at Dose Level 1 on Days 1, 57, and 169. Placebo Placebo Participants will receive 3 IM injections of vaccine-matching placebo on Days 1, 57, and 169. mRNA-1982: Dose 1 mRNA-1982 Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 1 on Days 1, 57, and 169. mRNA-1975: Dose 3 mRNA-1975 Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose Level 3 on Days 1, 57, and 169. mRNA-1975: Dose 2 mRNA-1975 Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 2 on Days 1, 57, and 169. mRNA-1982: Dose 2 mRNA-1982 Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 2 on Days 1, 57, and 169.
- Primary Outcome Measures
Name Time Method Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Up to Day 175 (7 days after each study injection) Number of Participants With Unsolicited Adverse Events (AEs) Up to Day 196 (28 days after each study injection) Number of Participants With Medically Attended AEs 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 Day 1 through Day 505 (End of Study)
- Secondary Outcome Measures
Name Time Method Geometric Mean Titer of Anti-outer Surface Protein A (anti-OspA) Binding Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay or a Similar Method Days 1, 29, 85, and 197 Geometric Mean Fold Rise of anti-OspA Binding IgG Antibody Titer at Days 29, 85, and 197 Compared to Day 1 (Baseline) Days 29, 85, and 197
Trial Locations
- Locations (20)
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
Meridian Clinical Research - Omaha
🇺🇸Omaha, Nebraska, 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
ActivMed Research LLC
🇺🇸Newington, New Hampshire, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
Hatboro Medical Associates/CCT Research
🇺🇸Hatboro, Pennsylvania, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, 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