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mRNA-1468

Phase 1

Herpes Zoster | Monoclonal antibody | Infectious Disease |Moderna, Inc.|Last Updated: Aug 13, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment659

FDA Designations

No designations recorded

Clinical trial landscape

mRNA-1468 · 1 trial · 1 indication

Phase 1 1
NCT05701800A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1468 in Healthy Adults ≥50 Years of AgeHerpes Zoster
ACTIVE NOT_RECRUITING659 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1468 in Healthy Adults ≥50 Years of Age
Herpes ZosterUnlock trial analytics

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 to 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

Frequently asked questions about mRNA-1468

What is mRNA-1468 used for?

mRNA-1468 is an investigational vaccine being developed for the prevention of Herpes Zoster, commonly known as shingles. It is currently in Phase 1 clinical development and is intended for use in healthy adults aged 50 years and older.

Who is developing mRNA-1468?

mRNA-1468 is being developed by Moderna, Inc., a biotechnology company publicly traded under the ticker symbol MRNA on the NASDAQ stock exchange. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational vaccine.

What phase is mRNA-1468 in?

mRNA-1468 is currently in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The ongoing Phase 1 study is evaluating its safety, reactogenicity, and immunogenicity in healthy adults aged 50 years and older.

What clinical trials is mRNA-1468 in?

mRNA-1468 is being studied in a Phase 1 clinical trial registered as NCT05701800. This trial is titled 'A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1468 in Healthy Adults ≥50 Years of Age' and is being conducted in the United States and Puerto Rico.

Is mRNA-1468 the same as any other vaccine?

mRNA-1468 is a distinct investigational vaccine candidate developed by Moderna. It is not known to be the same as any other vaccine product. Its specific formulation and mechanism are proprietary to Moderna and are being evaluated in clinical trials for the prevention of Herpes Zoster.