Drug intelligence / Profile preview

mRNA-1365

Development stage
Phase 1
Lead developer
Moderna
Modality
mRNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

**mRNA-1365** is Moderna's investigational, fixed-combination mRNA vaccine designed to prevent disease caused by respiratory syncytial virus and human metapneumovirus. It contains mRNA components encoding the respiratory syncytial virus prefusion fusion glycoprotein and the human metapneumovirus fusion glycoprotein, with the aim of eliciting neutralizing and cellular immune responses against both respiratory pathogens. The program has been evaluated in a Phase 1 pediatric study and is being evaluated in a Phase 1 study in healthy adults aged 60 years and older. Pediatric dosing in the earlier study was paused in July 2024 after a potential imbalance in severe respiratory syncytial virus lower respiratory tract illness was identified among vaccine recipients.

Other names
mRNA 1365mRNA1365mRNA-1365
02

Targets

HMPV F (Human metapneumovirus fusion protein)RSV F (Respiratory syncytial virus fusion protein)

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