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mRNA-1975

Phase 1

Lyme Disease | Monoclonal antibody | Other |Moderna, Inc.|Last Updated: Aug 22, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment807
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05975099A Study to Evaluate the Safety and Immunogenicity of mRNA-1975 and mRNA-1982 Against Lyme Disease in Participants 18 Through 70 Years of AgePHASE1 COMPLETED 807 — — Jul 26, 2023May 30, 2025Aug 22, 202520 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Up to Day 175 (7 days after each study injection)
Number of Participants With Unsolicited Adverse Events (AEs)
Up to Day 196 (28 days after each study injection)
Number of Participants With Medically Attended AEs
Day 1 through Day 337 (6 months after the last study injection)
Number of Participants with AEs of Special Interest, Serious AEs, and AEs Leading to Discontinuation of Study Injection or Study Participation
Day 1 through Day 505 (End of Study)
Secondary Endpoints
Geometric Mean Concentration of Anti-outer Surface Protein A (anti-OspA) Binding Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay or a Similar Method
Days 1, 29, 85, and 197
Geometric Mean Fold Rise of anti-OspA Binding IgG Antibody Concentration at Days 29, 85, and 197 Compared to Day 1 (Baseline)
Days 29, 85, and 197
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
mRNA-1975: Dose 1EXPERIMENTALParticipants will receive 3 intramuscular (IM) injections of the mRNA-1975 vaccine at Dose Level 1 on Days 1, 57, and 169.
mRNA-1975: Dose 2EXPERIMENTALParticipants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 2 on Days 1, 57, and 169.
mRNA-1975: Dose 3EXPERIMENTALParticipants will receive 3 IM injections of the mRNA-1975 vaccine at Dose Level 3 on Days 1, 57, and 169.
mRNA-1975: Dose 4EXPERIMENTALParticipants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 4 on Days 1, 57, and 169.
mRNA-1982: Dose 1EXPERIMENTALParticipants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 1 on Days 1, 57, and 169.
mRNA-1982: Dose 2EXPERIMENTALParticipants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 2 on Days 1, 57, and 169.
mRNA-1982: Dose 3EXPERIMENTALParticipants will receive 3 IM injections of the mRNA-1982 vaccine at Dose level 3 on Days 1, 57, and 169.
PlaceboPLACEBO_COMPARATORParticipants will receive 3 IM injections of vaccine-matching placebo on Days 1, 57, and 169.
Interventions
NameTypeDescription
mRNA-1975BIOLOGICALDispersion delivered IM
mRNA-1982BIOLOGICALDispersion delivered IM
PlaceboBIOLOGICALSolution delivered IM
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites20

Inclusion Criteria: * Body mass index of 18 to 39 kilograms/square meter (inclusive) at the Screening Visit. * Participants of nonchildbearing potential may be enrolled in the study. * For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstaine...

Countries:United States
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