A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982 to Prevent Lyme Disease in Healthy Participants (18 to 70 Years of Age)
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
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
Key Inclusion Criteria:
* 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.
Key Exclusion Criteria:
* 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.
* Had a tick bite within 4 weeks prior to Day 1.
Note: Additional inclusion/exclusion criteria may apply, per protocol.
Primary outcome measure(s)
Both Phases: Number of Participants with Solicited Local and Systemic Adverse Reactions — Day 1 up to Day 7 (7 days post-injection)
Both Phases: Number of Participants with Unsolicited Adverse Events — Day 1 up to Day 28 (28 days post-injection)
Both Phases: Number of Participants with Medically Attended Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, and Adverse Events Leading to Discontinuation — Day 1 up to Month 21 (End of study)
Trial sites (8)
Facility
City
Region
Status
Colchester Research Group
Truro
Nova Scotia
Bluewater Clinical Research Group Inc.
Sarnia
Ontario
Stouffville Medical Research Institute Inc.
Stouffville
Ontario
Dr. Anil K. Gupta Medicine Professional Corporation Inc.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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