Application of Systems Biology for the evaluation of vaccine safety and quality

2021 Fiscal Year Final Research Report

• Project/Area Number: 19K12873
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Review Section: Basic Section 90140:Medical technology assessment-related
• Research Institution: National Institute of Infectious Diseases
• Principal Investigator: Mizukami Takuo 国立感染症研究所, 血液・安全性研究部, 室長 (60415487)
• Project Period (FY): 2019-04-01 – 2022-03-31
• Keywords: システムズバイオロジー / ワクチン / アジュバント / 安全性 / バイオマーカー / 肺 / インフルエンザ

Outline of Final Research Achievements

Vaccine is most effective tool for preventing the infectious diseases. Most of the vaccine components are derived from inactivated pathogens, thus, the safety and consistency in a lot-to-lot basis are needed to ensure in the preclinical phase and after the licensure. However, these evaluation methods using animal for vaccine and adjuvant safety has not changed for long time.
Here we show that application of systems biology approaches enable to evaluate vaccine and adjuvant safety. We focused on the influenza vaccine and some adjuvants. We obtained the global gene expression profile after the vaccination in animal model and found that some typical gene signatures in lung clearly differed in each vaccine and adjuvant, respectively. We identified universal gene set that can evaluate safety of vaccine and adjuvant. This system will improve future evaluation methods for vaccine and adjuvant safety.

Free Research Field

ワクチン学

Academic Significance and Societal Importance of the Research Achievements

我々の研究は，WHOや欧州，特にドイツのPaul-Ehrlich-Institutや英国のNational Institute for Biological Standards and Control，　European Vaccine Initiativeなどを中心に様々なコンソーシアムが作られ，研究開発されている。我々はワクチン安全性評価，品質評価等に関し，先端の研究を実施し，成果を発表し，　試験法の国際調和の観点からも非常に期待されている。またワクチンの有効性・安全性を評価するバイオマーカーが確定できれば，新規ワクチンやアジュバントの開発にも繋がると考えられ，多くの発展が期待されている。