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)
A Phase 2, Randomized, Observer-blind, Dose-finding, Placebo-controlled Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982, an mRNA Vaccine to Prevent Lyme Disease in Healthy Adult Participants (18 to 70 Years of Age)
1 other identifier
interventional
350
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2026
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2026
CompletedStudy Start
First participant enrolled
April 27, 2026
CompletedFirst Posted
Study publicly available on registry
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 9, 2028
May 1, 2026
April 1, 2026
2.5 years
April 24, 2026
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
Secondary Outcomes (4)
Dose-finding Phase: Geometric Mean Concentration (GMC) of Anti-outer Surface Protein A (OspA) Serotype 1 (ST1) Binding Immunoglobulin G (IgG) Antibodies (Ab)
Days 1, 113, 197, 265, and 349
Dose-finding Phase: Geometric Mean Fold Rise (GMFR) of Anti-OspA ST1 Binding IgG Ab
Days 113, 197, 265, and 349
Booster Phase: GMC of Anti-OspA ST1 Binding IgG Ab
Days 1, 29, and 181 of Booster Phase
Booster Phase: GMFR of Anti-OspA ST1 Binding IgG Ab
Days 29 and 181 of Booster Phase
Study Arms (2)
Dose-finding Phase
EXPERIMENTALParticipants will receive mRNA-1982 or placebo as an intramuscular injection.
Booster Phase
EXPERIMENTALParticipants will receive mRNA-1982 (as a booster) or placebo as an intramuscular injection.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ModernaTX, Inc.lead
Study Sites (8)
Colchester Research Group
Truro, Nova Scotia, B2N 1L2, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, N7T 4X3, Canada
Stouffville Medical Research Institute Inc.
Stouffville, Ontario, L4A 1H2, Canada
Dr. Anil K. Gupta Medicine Professional Corporation Inc.
Toronto, Ontario, M9V 4B4, Canada
Diex Recherche Inc. - Division Joliette
Joliette, Quebec, J6E 6A9, Canada
Diex Recherche Inc. - Division Sherbrooke
Sherbrooke, Quebec, J1L 0H8, Canada
Diex Recherche Inc. - Division Victoriaville
Victoriaville, Quebec, G6P 3Z8, Canada
Diex Recherche Inc. - Division Quebec
Québec, G1V 4T3, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2026
First Posted
May 1, 2026
Study Start
April 27, 2026
Primary Completion (Estimated)
November 9, 2028
Study Completion (Estimated)
November 9, 2028
Last Updated
May 1, 2026
Record last verified: 2026-04