Immunogenicity and safety of AS03-adjuvanted A/Astrakhan/3212/2020 (H5N8)-like influenza vaccine in adults: Phase 1/2, observer-blinded, randomized trial.
Hum Vaccin ImmunotherJun 11, 2026 (epub)
Andrew Hastie, Vinay Gupta, Patricia Lese et al.
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In 30 seconds
This phase 1/2 randomized trial evaluated the immunogenicity and safety of GSK's AS03-adjuvanted H5N8 influenza vaccine in 518 healthy adults. The vaccine met FDA immunogenicity criteria, with higher immune responses observed in younger adults. Notably, seroprotection rates and geometric mean titers were greater in the AS03 A group compared to AS03 B.
Key findings
- On day 43, the vaccine met FDA immunogenicity criteria for influenza vaccines.
- Higher seroprotection rates and geometric mean titers were observed in the AS03 A group compared to AS03 B.
- Younger adults (18-64 years) exhibited stronger immune responses than older adults (≥65 years).
- The vaccine demonstrated an acceptable safety profile with no increase in adverse events post-dose 2.
Why it matters
Understanding the immunogenicity and safety of new influenza vaccines is crucial for pandemic preparedness. This study highlights a promising candidate that could enhance protection against emerging influenza strains, particularly in vulnerable populations.