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mRNA-1982

Phase 2

Lyme Disease | Vaccine | Infectious Disease |Moderna, Inc.|Trials Updated: Aug 3, 2026

mRNA-1982 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Aug 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment366

FDA Designations

No designations recorded

mRNA-1982 clinical trials

mRNA-1982 · 1 trial · 1 indication

Phase 2 1
NCT07561294A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982 to Prevent Lyme Disease in Healthy Participants (18 to 70 Years of Age)Lyme Disease
ACTIVE NOT_RECRUITING366 Analytics
PHASE2ACTIVE NOT_RECRUITING
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)
Lyme DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelSEQUENTIAL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Dose-finding PhaseEXPERIMENTALParticipants will receive mRNA-1982 or placebo as an intramuscular injection.
Booster PhaseEXPERIMENTALParticipants will receive mRNA-1982 (as a booster) or placebo as an intramuscular injection.

Interventions

NameTypeDescription
mRNA-1982BIOLOGICALSuspension for injection
PlaceboBIOLOGICALSuspension for injection
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites8

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 contracep...

Countries:Canada
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Recent Changes (Last 90 Days)

MEDIUMAug 3, 2026NCT07561294Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMAug 3, 2026NCT07561294Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about mRNA-1982

What is mRNA-1982 used for?

mRNA-1982 is an investigational vaccine being developed to prevent Lyme disease. It is designed for use in healthy adults aged 18 to 70 years. The vaccine is currently in Phase 2 clinical development and has not been approved for any indication.

Who is developing mRNA-1982?

mRNA-1982 is being developed by Moderna, Inc., which trades on the Nasdaq under the ticker symbol MRNA. Moderna is the sponsor of the clinical program evaluating the vaccine for the prevention of Lyme disease.

What phase is mRNA-1982 in?

mRNA-1982 is in Phase 2 clinical development. The only trial listed for this vaccine is a Phase 2 study, and it is currently active but not recruiting. The vaccine remains investigational and has not been approved by the FDA or any other regulatory agency.

What clinical trials is mRNA-1982 in?

mRNA-1982 is being evaluated in one clinical trial: NCT07561294, titled "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)." The trial is a controlled Phase 2 study with 366 participants, conducted in Canada, and is currently active but not recruiting.

Is mRNA-1982 a vaccine?

Yes, mRNA-1982 is an mRNA-based vaccine candidate intended to prevent Lyme disease. It is being tested in healthy volunteers aged 18 to 70 years to assess safety, reactogenicity, and immune response. The vaccine is still in clinical development and is not yet approved for use.