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mRNA-1519

Phase 1

Marburg Virus Disease (MVD) | Vaccines | Other |Moderna, Inc.|Trials Updated: Nov 5, 2026

mRNA-1519 development status

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

mRNA-1519 clinical trials

mRNA-1519 · 1 trial · 1 indication

Phase 1 1
NCT07919210A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of a Preventative Vaccine for Marburg Virus (mRNA-1519) in Healthy Adult ParticipantsMarburg Virus Disease (MVD)
NOT YET_RECRUITING64 Analytics
PHASE1NOT YET_RECRUITING
A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of a Preventative Vaccine for Marburg Virus (mRNA-1519) in Healthy Adult Participants
Marburg Virus Disease (MVD)
NCT0791921064
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Study Endpoints

Primary Endpoints

Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Through 7 days after each study intervention
Number of Participants with Unsolicited Adverse Events (AEs)
Through 28 days after each study intervention
Number of Participants with Medically Attended Adverse Events (MAAEs)
From Day 1 to 6 months after the last study intervention
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 Titer of Marburg Virus (MARV)-Specific Binding Antibodies (bAbs)
At Day 29 (Single Dose), at Day 85 (Two-Dose), and Up to EOS (Day 337)
Geometric Mean Titer of Marburg Virus (MARV)-Specific Neutralizing Antibodies (nAbs)
Throughout the study (Up to EOS/Day 337)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
mRNA-1519 Dose Level 1 Single DoseEXPERIMENTALParticipants will receive 1 injection of mRNA-1519 at Dose Level 1 on Day 1
Placebo Matching Dose Level 1 Single DosePLACEBO_COMPARATORParticipants will receive 1 injection of Placebo matching Dose Level 1 on Day 1
mRNA-1519 Dose Level 1 Two-DoseEXPERIMENTALParticipants will receive 2 injections of mRNA-1519 at Dose Level 1, on Day 1 and Day 57
Placebo Matching Dose Level 1 Two-DosePLACEBO_COMPARATORParticipants will receive 2 injections of Placebo matching Dose Level 1, on Day 1 and Day 57
mRNA-1519 Dose Level 2EXPERIMENTALParticipants will receive 1 injection of mRNA-1519 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-1519 Dose Level 3EXPERIMENTALParticipants will receive 1 injection of mRNA-1519 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-1519BIOLOGICALSterile liquid for injection
PlaceboBIOLOGICALSterile liquid for injection
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 to 39 kg/m2 (inclusive). * Female participants of childbearing...

Countries:United Kingdom
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Recent Changes (Last 90 Days)

LOWNov 5, 2026NCT07919210NEW_TRIAL: changed
LOWNov 5, 2026NCT07919210NEW_TRIAL: changed

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