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mRNA-1469

Phase 1

Ebola-Bundibugyo Virus Disease (Ebola-BDBV) | Vaccine | Infectious Disease |Moderna, Inc.|Trials Updated: Sep 24, 2026

mRNA-1469 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment84

FDA Designations

No designations recorded

mRNA-1469 clinical trials

mRNA-1469 · 1 trial · 1 indication

Phase 1 1
NCT07737717A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult ParticipantsEbola-Bundibugyo Virus Disease (Ebola-BDBV)
ACTIVE NOT_RECRUITING84 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult Participants
Ebola-Bundibugyo Virus Disease (Ebola-BDBV)Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Up to Day 7 (the day of study intervention and 6 subsequent days)
Number of Participants with Unsolicited Adverse Events (AEs)
Up to Day 28 (the day of study intervention and 27 subsequent days)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Up to Day 169 (6 months follow-up after injection)
Number of Participants with Serious Adverse Events (SAEs), Any AEs Leading to Discontinuation From Study Participation and/or Study Vaccination, and AEs of Special Interest (AESIs)
Up to End of Study (EOS) (Day 337)

Secondary Endpoints

Geometric Mean of Bundibugyo Ebolavirus (BDBV)-Specific Binding Antibodies (bAbs)
At Day 29 and Up to Day 337
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
mRNA-1469 Dose Level 1EXPERIMENTALParticipants will receive 1 injection of mRNA-1469 at Dose Level 1 on Day 1.
Placebo Matching Dose Level 1PLACEBO_COMPARATORParticipants will receive 1 injection of Placebo matching Dose Level 1 on Day 1.
mRNA-1469 Dose Level 2EXPERIMENTALParticipants will receive 1 injection of mRNA-1469 at Dose Level 2 on Day 1.
Placebo Matching Dose Level 2PLACEBO_COMPARATORParticipants will receive 1 injection of Placebo matching Dose Level 2 on Day 1.
mRNA-1469 Dose Level 3EXPERIMENTALParticipants will receive 1 injection of mRNA-1469 at Dose Level 3 on Day 1.
Placebo Matching Dose Level 3PLACEBO_COMPARATORParticipants will receive 1 injection of Placebo matching Dose Level 3 on Day 1.

Interventions

NameTypeDescription
mRNA-1469BIOLOGICALSterile liquid for injection
PlaceboBIOLOGICALSterile liquid for injection
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

Key Inclusion Criteria: * In good general health or with stable chronic medical conditions, as determined by medical evaluation including medical history, physical examination, and laboratory tests. * Body mass index within the range 18.5 to 39 kg/m2 (inclusive). * Female participants of childbeari...

Countries:Canada
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Recent Changes (Last 90 Days)

MEDIUMSep 24, 2026NCT07737717Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMSep 24, 2026NCT07737717Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWSep 10, 2026NCT07737717lastUpdatePostDate: changed
LOWSep 10, 2026NCT07737717lastUpdatePostDate: changed
LOWAug 11, 2026NCT07737717Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 11, 2026NCT07737717Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 30, 2026NCT07737717NEW_TRIAL: changed
LOWJul 30, 2026NCT07737717NEW_TRIAL: changed

Frequently asked questions about mRNA-1469

What is mRNA-1469?

mRNA-1469 is an investigational mRNA vaccine developed by Moderna, Inc. (ticker MRNA) for the prevention of Ebola-Bundibugyo Virus Disease, also known as Ebola-BDBV. It is in Phase 1 clinical development and is designed to be given to healthy adult volunteers to prevent infection with the Bundibugyo strain of Ebola virus.

What is mRNA-1469 used for in Ebola-Bundibugyo Virus Disease?

mRNA-1469 is being developed to prevent Ebola-Bundibugyo Virus Disease (Ebola-BDBV) in healthy adults. It is a preventive vaccine candidate, not a treatment for people already infected. The Phase 1 study is evaluating whether the vaccine is safe and generates an immune response against the Bundibugyo virus.

Who makes mRNA-1469?

mRNA-1469 is developed by Moderna, Inc., which trades on the Nasdaq under the ticker MRNA. Moderna is running the Phase 1 clinical program for the vaccine candidate, which is being studied in Canada in healthy adult participants aged 18 years and older.

What phase is mRNA-1469 in?

mRNA-1469 is in Phase 1 clinical development. It is an investigational vaccine candidate and has not been approved by the FDA or any other regulatory agency. One Phase 1 trial is currently active, and no trials of mRNA-1469 have been completed to date.

What clinical trials is mRNA-1469 in?

mRNA-1469 is being studied in one Phase 1 trial, NCT07737717, titled a study to investigate the safety, reactogenicity, and immunogenicity of mRNA-1469 vaccine to prevent Ebola-Bundibugyo Virus Disease in healthy adult participants. The trial is active but not recruiting, is placebo-controlled and double-blind, and has enrolled 84 participants in Canada.

How is the mRNA-1469 trial designed?

The Phase 1 trial of mRNA-1469, NCT07737717, is a randomized, double-blind, placebo-controlled study enrolling 84 healthy adult participants of all sexes, aged 18 years and older, in Canada. It is assessing safety, reactogenicity, and immunogenicity of the vaccine candidate against Ebola-Bundibugyo Virus Disease. The trial is active and no longer recruiting.