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mRNA-1769

Phase 1

Smallpox | Monoclonal antibody | Infectious Disease |Moderna, Inc.|Last Updated: Jul 16, 2025

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

Clinical trial landscape

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
Smallpox
NCT05995275351
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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 used for?

mRNA-1769 is an investigational vaccine being studied for the prevention of smallpox and mpox. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes mRNA-1769?

mRNA-1769 is being developed by Moderna, Inc., a biotechnology company traded on the NASDAQ under the ticker symbol MRNA.

What phase is mRNA-1769 in?

mRNA-1769 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved for use outside of clinical trials.

What clinical trials is mRNA-1769 in?

mRNA-1769 is being evaluated in a Phase 1 clinical trial with the identifier NCT05995275. This randomized, double-blind, placebo-controlled study is investigating the safety, tolerability, and immune response of multiple doses of mRNA-1769 in healthy adults aged 18 to under 50 years.

Is mRNA-1769 the same as a smallpox vaccine?

mRNA-1769 is an investigational vaccine designed to target smallpox and mpox. It is not the same as traditional smallpox vaccines, as it uses mRNA technology rather than a live or attenuated virus.