Status:
COMPLETED
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
Lead Sponsor:
ModernaTX, Inc.
Conditions:
Lyme Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
807 Patients enrolled
Trial Details
Trial ID
NCT05975099
Start Date
July 26 2023
End Date
May 30 2025
Last Update
August 22 2025
Active Locations (20)
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1
Clinical Research Consulting, LLC
Milford, Connecticut, United States, 06460
2
Stamford Therapeutics Consortium
Stamford, Connecticut, United States, 06905
3
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
4
Encore Research Group-Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216