About this trial
This clinical study will evaluate the safety, reactogenicity, and immunogenicity of monovalent mRNA-1982, a messenger ribonucleic acid (mRNA) vaccine to prevent Lyme disease in healthy adults aged 18 to 70 years old.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
In good general health in the opinion of the investigator as determined by medical evaluation including medical history and physical examination at screening.
Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Disqualifiers
History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic.
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.
Previously vaccinated against Lyme disease or participated in the past in any vaccine study for Lyme disease.
Trial design
Sequential
Treatments tested in this trial
mRNA-1982
Biological/VaccineSuspension for injection
Placebo
Biological/VaccineSuspension for injection
Treatment groups
Trial outcomes
Primary outcomes
Both Phases: Number of Participants with Solicited Local and Systemic Adverse Reactions
Both Phases: Number of Participants with Unsolicited Adverse Events
Both Phases: Number of Participants with Medically Attended Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, and Adverse Events Leading to Discontinuation
Secondary outcomes
Dose-finding Phase: Geometric Mean Concentration (GMC) of Anti-outer Surface Protein A (OspA) Serotype 1 (ST1) Binding Immunoglobulin G (IgG) Antibodies (Ab)
Dose-finding Phase: Geometric Mean Fold Rise (GMFR) of Anti-OspA ST1 Binding IgG Ab
Booster Phase: GMC of Anti-OspA ST1 Binding IgG Ab
Booster Phase: GMFR of Anti-OspA ST1 Binding IgG Ab
Sponsors and contacts
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