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mRNA-1468

Phase 1

Herpes Zoster | Monoclonal antibody | Infectious Disease |Moderna, Inc.|Last Updated: Aug 13, 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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment659
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05701800A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1468 in Healthy Adults ≥50 Years of AgePHASE1 ACTIVE NOT_RECRUITING 659 — — Jan 23, 2023Jun 30, 2026Aug 13, 202520 United States, Puerto Rico
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Study Endpoints
Primary Endpoints
Number Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions
Up to Day 64 (7 days after each injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Up to Day 85 (28 days after each injection)
Number of Participants with Serious AEs, AEs Leading to Discontinuation of Study Vaccine or Withdrawal From the Study, and AEs of Special Interest
Day 1 to End of Study (up to a maximum of Day 1113)
Number of Participants with Medically Attended AEs
Day 1 to Day 393 (12 months after last study injection)
Secondary Endpoints
Vaccine Seroresponse Rate of Participants
Day 85 and Day 225 (1 and 6 months after the last injection)
Geometric Mean Concentration of Anti-gE-specific bAb as Measured by Enzyme-linked Immunosorbent Assay
Day 85 and Day 225 (1 and 6 months after the last injection)
Change from Baseline in Geometric Mean Fold Rise of Anti-gE-specific bAb Concentration
Baseline, Day 85 and Day 225 (1 and 6 months after the last injection)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Part 1: mRNA-1468: Dose 1EXPERIMENTALParticipants will receive placebo by intramuscular (IM) injection on Day 1 followed with mRNA-1468 by IM injection on Day 57 in Part 1.
Part 1: mRNA-1468: Dose 2EXPERIMENTALParticipants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1.
Part 1: mRNA-1468: Dose 3EXPERIMENTALParticipants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1.
Part 1: mRNA-1468: Dose 4EXPERIMENTALParticipants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1.
Part 1: ShingrixACTIVE_COMPARATORParticipants will receive Shingrix by IM injection on Day 1 and Day 57 in Part 1.
Part 2: mRNA-1468: Dose 5EXPERIMENTALParticipants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 2.
Part 2: mRNA-1468: Dose 6EXPERIMENTALParticipants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 2.
Part 2: ShingrixACTIVE_COMPARATORParticipants will receive Shingrix by IM injection on Day 1 and Day 57 in Part 2.
Interventions
NameTypeDescription
mRNA-1468BIOLOGICALSterile liquid dispersion for injection
PlaceboBIOLOGICALSterile liquid for injection
ShingrixBIOLOGICALSterile suspension for injection
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites20

Inclusion Criteria: * Part 1: Is an adult 50 years of age or older at the time of consent. Part 2: Is an adult 50-69 years of age at the time of consent. * Has a body mass index of 18 to \<40 kilograms/meter squared at the Screening Visit. * Females of childbearing potential: have a negative pregna...

Countries:United StatesPuerto Rico
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05701800primaryCompletionDate: changed
LOWMay 24, 2026NCT05701800studyFirstPostDate: changed