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mRNA-1769

Phase 1

Smallpox | Vaccine | Infectious Disease |Moderna, Inc.|Trials Updated: Jul 16, 2025

mRNA-1769 development status

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment351

FDA Designations

No designations recorded

mRNA-1769 clinical trials

mRNA-1769 · 1 trial · 2 indications

Phase 1 1
NCT05995275A Study to Investigate The Safety, Tolerability, And Immune Response of a Range of Doses of mRNA-1769 Compared With Placebo in Healthy Participants From ≥18 Years of Age to <50 Years of AgeSmallpox
COMPLETED351 Analytics
PHASE1COMPLETED
A Study to Investigate The Safety, Tolerability, And Immune Response of a Range of Doses of mRNA-1769 Compared With Placebo in Healthy Participants From ≥18 Years of Age to <50 Years of Age
SmallpoxUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Through 7 Days After Each Investigational Medicinal Product (IMP)
Up to Day 35
Number of Unsolicited Adverse Events (AEs) Through 7 Days After Each IMP
Up to Day 57
Number of Participants with Medically-Attended AEs (MAAEs)
Day 1 up to Day 395
Number of Participants with Adverse Events of Special Interest (AESIs)
Day 1 up to Day 395
Number of Participants with Serious Adverse Events (SAEs)
Day 1 up to Day 395
Number of Participants with AEs Leading to Study and/or Treatment Discontinuation
Day 1 up to Day 395

Secondary Endpoints

Geometric Mean Titer (GMT) of Neutralising Antibody (nAb) against Mpox Virus (MPXV) by Plaque reduction neutralisation test (PRNT)
Days 1 and 43
Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against MPXV
Days 1 and 43
Geometric Mean Concentration of Binding Antibodies (bAbs) Against MPXV Antigens by Meso Scale Discovery (MSD) Assay
Days 1, 29, 43, and 57
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
mRNA-1769 Dose AEXPERIMENTALParticipants will receive intramuscular (IM) injection of mRNA-1769 at Dose A on Day 1 and Day 29.
mRNA-1769 Dose BEXPERIMENTALParticipants will receive IM injection of mRNA-1769 at Dose B on Day 1 and Day 29.
mRNA-1769 Dose CEXPERIMENTALParticipants will receive IM injection of mRNA-1769 at Dose C on Day 1 and Day 29.
PlaceboPLACEBO_COMPARATORParticipants will receive IM injection of placebo matched to mRNA-1769 on Day 1 and Day 29.

Interventions

NameTypeDescription
mRNA-1769BIOLOGICALSterile liquid for injection
PlaceboOTHER0.9% sodium chloride injection (normal saline)
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Eligibility Criteria

Age Range18 Years to 49 Years
SexALL
Healthy VolunteersYes
Study Sites12

Inclusion Criteria: * Has a body mass index (BMI) between ≥18 kilogram per square meter (kg/m\^2) to ≤39 kg/m\^2. * For female participants of childbearing potential: must have a negative highly sensitive pregnancy test with 28 days before the first dose of study drug, uses approved contraception d...

Countries:United Kingdom
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Frequently asked questions about mRNA-1769

What is mRNA-1769?

mRNA-1769 is an investigational mRNA vaccine developed by Moderna, Inc. for the prevention of smallpox. It is in Phase 1 clinical development and has been studied in healthy adult participants. It is a vaccine candidate and is not approved for use.

What is mRNA-1769 used for?

mRNA-1769 is being developed for smallpox, with the related condition mpox also listed among the conditions studied in its clinical trial. It is an investigational vaccine candidate and has not been approved for any indication.

Who makes mRNA-1769?

mRNA-1769 is developed by Moderna, Inc., which trades on the Nasdaq under the ticker MRNA. Moderna is the sponsor of the clinical program evaluating the vaccine candidate.

What phase is mRNA-1769 in?

mRNA-1769 is in Phase 1 clinical development. Its single Phase 1 trial has been completed. The vaccine candidate is investigational and has not been approved by the FDA or any other regulatory agency.

What clinical trials is mRNA-1769 in?

mRNA-1769 has been evaluated in one Phase 1 trial, NCT05995275, titled a study of the safety, tolerability, and immune response of a range of doses of mRNA-1769 compared with placebo in healthy participants. The trial enrolled 351 participants in the United Kingdom and is completed.

How was the mRNA-1769 Phase 1 trial designed?

The Phase 1 trial NCT05995275 was a randomized, double-blind, placebo-controlled study of a range of doses of mRNA-1769 in healthy participants aged 18 to under 50 years. It enrolled 351 participants in the United Kingdom and has been completed.