Safety and immunogenicity of an investigational mRNA-lipid nanoparticle-based monovalent influenza vaccine: Results from a phase 1, randomized, dose-escalation study - PubMed
3 days ago
- #immunogenicity
- #mRNA vaccine
- #influenza
- Study evaluated safety and immunogenicity of an mRNA-based monovalent influenza vaccine (FLUmHA) in younger (18-45 y) and older adults (60-80 y).
- Solicited adverse events (AEs) increased with FLUmHA dose levels in younger adults (62.5%-100%), with severe AEs ranging 0.0%-20.8%. Older adults reported 62.5% AEs (FLUmHA) vs. 56.3% (Flu D-QIV).
- Unsolicited AEs within 28 days post-vaccination were reported by 50.0%-70.8% of younger adults (FLUmHA) vs. 68.6% (Flu D-QIV), and 43.8% (FLUmHA) vs. 50.0% (Flu D-QIV) in older adults.
- No safety concerns were identified. A/H1N1 hemagglutination inhibition titers increased post-vaccination, showing dose-dependent response, higher in FLUmHA (>1 µg) vs. Flu D-QIV recipients.
- FLUmHA elicited a higher hemagglutinin-specific CD4+ T-cell response (Th1 profile) than Flu D-QIV in both age groups.
- Results support progression to clinical development of a multivalent mRNA Flu vaccine candidate.