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mRNA-1365

Phase 1

Respiratory Syncytial Virus (RSV) | Vaccine | Infectious Disease |Moderna, Inc.|Trials Updated: Aug 19, 2026

mRNA-1365 development status

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

mRNA-1365 target and mechanism

Molecular targetRSV prefusion F glycoprotein and hMPV F protein
Target classGlycoprotein
ModalityVaccine

Also known as mRNA-1365 (Profile 2)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment375

FDA Designations

No designations recorded

mRNA-1365 clinical trials

mRNA-1365 · 1 trial · 2 indications

Phase 1 1
NCT07764237A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy AdultsRespiratory Syncytial Virus (RSV)
RECRUITING375 Analytics
PHASE1RECRUITING
A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy Adults
Respiratory Syncytial Virus (RSV)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), Serious Adverse Events (SAEs), Any AEs Leading to Study Discontinuation, and AEs of Special Interest (AESIs)
Up to End of Study (EOS) (Day 181)

Secondary Endpoints

Geometric Mean Level of Serum Neutralizing Antibodies (nAbs)
Day 29
Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAbs)
Day 29
Percentage of Particpants with Seroresponse Based on Serum Neutralizing Antibodies (nAbs) Level
Day 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
mRNA-1365 (Profile 2) Dose Level 1EXPERIMENTALParticipants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 1 on Day 1.
mRNA-1365 (Profile 2) Dose Level 2EXPERIMENTALParticipants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 2 on Day 1.
mRNA-1365 (Profile 2) Dose Level 3EXPERIMENTALParticipants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 3 on Day 1.
mRNA-1345 (Profile 1)ACTIVE_COMPARATORParticipants will receive 1 injection of mRNA-1345 (Profile 1) on Day 1.
mRNA-1345 (Profile 3)ACTIVE_COMPARATORParticipants will receive 1 injection of mRNA-1345 (Profile 3) on Day 1.

Interventions

NameTypeDescription
mRNA-1365 (Profile 2)BIOLOGICALSterile liquid for injection
mRNA-1345 (Profile 1)BIOLOGICALSterile liquid for injection
mRNA-1345 (Profile 3)BIOLOGICALSterile liquid for injection
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Eligibility Criteria

Age Range60 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites10

Key Inclusion Criteria: * In good general health or with stable chronic medical conditions, as determined by medical evaluation including medical history and physical examination. * Body mass index within the range 18.5 to 35 kg/m2 (inclusive). Key Exclusion Criteria: * History of anaphylaxis or ...

Countries:CanadaUnited Kingdom
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Recent Changes (Last 90 Days)

LOWAug 20, 2026NCT07764237Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07764237Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07764237Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07764237Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 14, 2026NCT07764237NEW_TRIAL: changed
LOWAug 14, 2026NCT07764237NEW_TRIAL: changed
LOWAug 14, 2026NCT07764237NEW_TRIAL: changed

Frequently asked questions about mRNA-1365

What is mRNA-1365?

mRNA-1365 is an investigational vaccine developed by Moderna, Inc. for respiratory syncytial virus (RSV). It is also being studied against human metapneumovirus (hMPV). The vaccine is in Phase 1 clinical development and has not been approved by any regulatory agency.

What is mRNA-1365 used for in RSV?

mRNA-1365 is being developed to prevent respiratory syncytial virus (RSV) in older adults. The Phase 1 study enrolls healthy adults aged 60 years and older. It is also being evaluated against human metapneumovirus (hMPV), and it remains investigational.

What does mRNA-1365 target?

mRNA-1365 targets the RSV prefusion F glycoprotein and the hMPV F protein. Both are surface glycoproteins that the vaccine is designed to elicit immune responses against. Targeting the prefusion F conformation is intended to generate neutralizing antibodies against these respiratory viruses.

Who is developing mRNA-1365?

mRNA-1365 is being developed by Moderna, Inc., which trades on the Nasdaq under the ticker MRNA. Moderna is the sponsor of the Phase 1 clinical trial evaluating the vaccine in older healthy adults.

What phase is mRNA-1365 in?

mRNA-1365 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA or any other regulatory authority. The single Phase 1 trial is currently recruiting participants.

What clinical trials is mRNA-1365 in?

mRNA-1365 is being studied in one active Phase 1 trial, NCT07764237, titled a study to investigate safety, reactogenicity, and immunogenicity of mRNA-1365 (Profile 2) in older healthy adults. The trial is recruiting 375 participants across Canada and the United Kingdom.

Is mRNA-1365 the same as mRNA-1365 (Profile 2)?

Yes, mRNA-1365 (Profile 2) refers to the same investigational vaccine as mRNA-1365. The Profile 2 designation appears in the Phase 1 trial title, NCT07764237, which evaluates the vaccine in healthy adults aged 60 years and older.