Destexhe Eric
GSK, Rue de l'Institut 89, 1330, Rixensart, Belgium.
NPJ Vaccines. 2025 Aug 13;10(1):192. doi: 10.1038/s41541-025-01245-3.
Vaccine platform technologies are reproducible, standardized manufacturing and development methods that may be leveraged to streamline regulatory approval of new vaccines. To evaluate the plausibility of a platform approach for the nonclinical safety assessment of adjuvanted recombinant-protein vaccine candidates, a comparative analysis was performed on repeat-dose toxicity data of four AS01 adjuvanted candidate vaccines from five rabbit studies. Groups of animals received AS01-adjuvanted vaccines, AS01 alone, or antigens alone on multiple occasions. All vaccines were well-tolerated, showing mainly transient signs of inflammation after the administrations, consistent across all vaccines and similar to AS01. The antigens alone induced only minimal signs of inflammation, indicating that AS01 mainly drives the innate immune response. These findings support the plausibility of a platform approach for the nonclinical safety assessment of adjuvanted vaccines, potentially reducing animal use and expediting first-in-human trials by streamlining or eliminating some nonclinical studies.
疫苗平台技术是可重复、标准化的制造和开发方法，可用于简化新疫苗的监管审批。为评估平台方法用于佐剂重组蛋白候选疫苗非临床安全性评估的合理性，对五项兔研究中四种AS01佐剂候选疫苗的重复剂量毒性数据进行了比较分析。动物组多次接受AS01佐剂疫苗、单独的AS01或单独的抗原。所有疫苗耐受性良好，给药后主要表现为短暂的炎症迹象，所有疫苗一致且与AS01相似。单独的抗原仅引起轻微的炎症迹象，表明AS01主要驱动先天免疫反应。这些发现支持了平台方法用于佐剂疫苗非临床安全性评估的合理性，有可能通过简化或消除一些非临床研究来减少动物使用并加快首次人体试验。
