4.5 Review

Pharmacodynamic and safety considerations for influenza vaccine and adjuvant design

Journal

EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY
Volume 16, Issue 11, Pages 1051-1061

Publisher

TAYLOR & FRANCIS LTD
DOI: 10.1080/17425255.2020.1807936

Keywords

Adjuvant; biomarker; genomics; immunotoxicity; influenza vaccine; preclinical test; pharmacodynamics; safety evaluation

Funding

  1. Japan Agency for Medical Research and Development (AMED) [JP19fk0108051, JP19fk0108100, JP18ak0101071]
  2. Ministry of Education, Culture, Sports, Science and Technology, Japan Society for the Promotion of Science [19K12873]
  3. Grants-in-Aid for Scientific Research [19K12873] Funding Source: KAKEN

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Introduction 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. Areas covered A conventionalin vivoevaluation 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(TM)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. Expert opinion 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.

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