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Completed
NCT05975099
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
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: Yes
Phase: PHASE1, PHASE2
Enrollment: 807
Sponsor: ModernaTX, Inc.
Location: Clinical Research Consulting, LLC Milford Connecticut
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 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.
Source: ClinicalTrials.gov (NCT05975099). StuddyBuddy aggregates publicly available trial information.