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mRNA-1982

Phase 2

Lyme Disease | Monoclonal antibody | Infectious Disease |Moderna, Inc.|Last Updated: Aug 3, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment366

FDA Designations

No designations recorded

Clinical trial landscape

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 Disease
NCT07561294366
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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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Competitive Landscape -Alzheimer's Disease 66 trials (matched to "Lyme Disease")

Top 20 of 24 competitors

CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY9PHASE3KarXT, KarX-EC
Eli Lilly and CompanyLLY12PHASE3Donanemab, Dexamethasone
Biogen Inc.BIIB2PHASE3Lecanemab
Annovis Bio IncANVS1PHASE3buntanetap/posiphen
ACADIA Pharmaceuticals Inc.ACAD2PHASE3ACP-204
Novartis AG Sponsored ADRNVS2PHASE2VHB937
GSK plc Sponsored ADRGSK2PHASE2GSK4527226
Cognition Therapeutics, Inc.CGTX2PHASE2CT1812
Johnson & JohnsonJNJ1PHASE2JNJ-64042056
Merck & Co., Inc.MRK1PHASE2MK-2214
Lantheus Holdings IncLNTH2PHASE3Nilotinib BE
Acumen Pharmaceuticals, Inc.ABOS1PHASE2sabirnetug
Aclaris Therapeutics, Inc.ACRS1PHASE2ATI-045
IGC Pharma, Inc.IGC1PHASE2IGC-AD1-Active
Alnylam Pharmaceuticals, IncALNY2PHASE1ALN-5288
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE1ARO-MAPT
AC Immune SAACIU2PHASE1ACI-24.060 at Dose A in Study Part 1a, ACI-24.060 at Dose B in Study Part 1a, ACI-24.060 at Dose C in Study Part 1a, ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b, ACI-24.060 at Dose A in Study Part 2
Denali Therapeutics Inc.DNLI1PHASE1DNL628
Alzamend Neuro, Inc.ALZN1PHASE1ALZN002
Voyager Therapeutics, Inc.VYGR1PHASE1VY7523
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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 in healthy adults. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes mRNA-1982?

mRNA-1982 is being developed by Moderna, Inc., a biotechnology company traded on the NASDAQ under the ticker symbol MRNA.

What phase is mRNA-1982 in?

mRNA-1982 is currently in Phase 2 clinical development. It is an investigational vaccine 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 a Phase 2 clinical trial with the identifier NCT07561294. This study is assessing the safety, reactogenicity, and immunogenicity of the vaccine in healthy participants aged 18 to 70 years.

Is mRNA-1982 the same as a Lyme disease vaccine?

mRNA-1982 is a vaccine candidate specifically designed to prevent Lyme disease. It is being studied in a controlled clinical trial with 366 participants in Canada.