A platform approach as a plausible option for nonclinical safety assessment of adjuvanted vaccines.

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.