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mRNA-1469

Phase 1

Ebola-Bundibugyo Virus Disease (Ebola-BDBV) | Monoclonal antibody | Infectious Disease |Moderna, Inc.|Last Updated: Aug 11, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

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)
RECRUITING84 Analytics
PHASE1RECRUITING
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)
NCT0773771784
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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)

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 used for?

mRNA-1469 is an investigational vaccine being developed to prevent Ebola-Bundibugyo Virus Disease (Ebola-BDBV), a viral illness caused by the Bundibugyo ebolavirus. It is currently in Phase 1 clinical development and is not yet approved for use.

Who makes mRNA-1469?

mRNA-1469 is being developed by Moderna, Inc., a biotechnology company traded on the Nasdaq under the ticker symbol MRNA. The company is conducting a Phase 1 clinical trial to evaluate the vaccine's safety, reactogenicity, and immunogenicity in healthy adults.

What phase is mRNA-1469 in?

mRNA-1469 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants in Canada to assess the vaccine's safety and immune response.

What clinical trials is mRNA-1469 in?

mRNA-1469 is being studied in a Phase 1 clinical trial registered as NCT07737717. This randomized, double-blind, placebo-controlled study is evaluating the safety, reactogenicity, and immunogenicity of the vaccine in healthy adult participants aged 18 years and older in Canada.

How does mRNA-1469 work?

mRNA-1469 is a messenger RNA (mRNA) vaccine designed to instruct cells to produce a viral protein that triggers an immune response against the Bundibugyo ebolavirus. This approach aims to generate protective antibodies and immune memory to prevent Ebola-Bundibugyo Virus Disease.