Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases , Tokyo, Japan.
Expert Opin Drug Metab Toxicol. 2020 Nov;16(11):1051-1061. doi: 10.1080/17425255.2020.1807936. Epub 2020 Aug 24.
A novel adjuvant evaluation system for safety and immunogenicity is needed. Vaccination is important for infection prevention, for example, from influenza viruses. Adjuvants are considered critical for improving the effectiveness of influenza vaccines. Adjuvant development is an important issue in influenza vaccine design.
A conventional evaluation method for vaccine safety has been limited in analyzing phenotypic and pathological changes. Therefore, it is difficult to obtain information on the changes at the molecular level. This review aims to explain the recently developed genomics analysis-based vaccine adjuvant safety evaluation tools verified by AddaVax and polyinosinic-polycytidylic acid (poly I:C) using 18 biomarker genes and whole-virion inactivated influenza vaccine as a toxicity control. Genomics analyzes would help provide safety and efficacy information regarding influenza vaccine design by facilitating appropriate adjuvant selection.
The efficacy and safety profiles of influenza vaccines and adjuvants using genomics technologies provide useful information regarding immunogenicity, which is related to safety and efficacy. This approach provides important information to select appropriate inoculation routes, combinations of vaccine antigens and adjuvants, and dosing amounts. The efficacy of vaccine adjuvant evaluation by genomics analysis should be verified by various studies using various vaccines in the future.
需要建立一个新的佐剂安全性和免疫原性评估体系。接种疫苗对于预防感染非常重要,例如预防流感病毒。佐剂被认为是提高流感疫苗效果的关键。佐剂的开发是流感疫苗设计中的一个重要问题。
传统的疫苗安全性评估方法在分析表型和病理变化方面受到限制。因此,很难获得分子水平变化的信息。本综述旨在解释最近开发的基于基因组学分析的疫苗佐剂安全性评估工具,该工具使用 AddaVax 和聚肌苷酸-聚胞苷酸(poly I:C)通过 18 个生物标志物基因和全病毒灭活流感疫苗进行了验证。基因组学分析将有助于通过选择合适的佐剂提供有关流感疫苗设计的安全性和有效性信息。
使用基因组学技术的流感疫苗和佐剂的功效和安全性概况提供了有关免疫原性的有用信息,而免疫原性与安全性和功效相关。这种方法提供了有关选择合适接种途径、疫苗抗原和佐剂组合以及剂量的重要信息。未来应通过使用各种疫苗的各种研究来验证基因组学分析评估疫苗佐剂的功效。