Destexhe, E. A platform approach as a plausible option for nonclinical safety assessment of adjuvanted vaccines. NPJ Vaccines, 2025 Aug 13, 10(1):192.

Destexhe, E. A platform approach as a plausible option for nonclinical safety assessment of adjuvanted vaccines. NPJ Vaccines, 2025 Aug 13, 10(1):192. PMID: 40804241

• This study supports a platform-based approach for the nonclinical safety assessment of adjuvanted vaccines, specifically those using the AS01 adjuvant.
• It demonstrates that across multiple rabbit studies involving different recombinant proteins, AS01 consistently induces transient inflammatory responses, whereas the antigens alone cause minimal reactogenicity. These findings suggest that the adjuvant primarily drives the innate immune response and reactogenicity, allowing safety data from prior studies with similar adjuvants to be leveraged for new vaccine candidates. 
• This consistent and predictable reactogenicity supports the use of a platform-based approach for nonclinical safety assessment, which could reduce animal testing and streamline the development and regulatory approval of future adjuvanted vaccines without compromising safety. This methodology can effectively assess the safety of adjuvanted vaccines, especially when using well-characterized adjuvants and antigens, and facilitating the transition to human clinical trials.

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