mRNA Tolerogenic Vaccine for T1D Prevention — Phase I First-in-Human

Type: immunotherapy

Status: Early Development — First Patients Enrolled

Developer: Moderna / Academic Collaborators

Breakthrough Summary

Leveraging mRNA-LNP technology from COVID-19 vaccines, researchers encode tolerogenic antigens to retrain the immune system and halt autoimmune beta cell destruction. Preclinical data in NOD mice showed 60-80% prevention of diabetes onset. First-in-human trials targeting at-risk Stage 1 T1D individuals began enrollment late 2025.

Mechanism of Action

mRNA encodes autoantigens (GAD65, proinsulin) in a tolerogenic context, delivered via lipid nanoparticles to antigen-presenting cells. This induces regulatory T cells specific to islet antigens, suppressing the autoimmune cascade without broad immunosuppression.

Year: 2025-2026