TY - JOUR
T1 - Establishment of a novel safety assessment method for vaccine adjuvant development
AU - Sasaki, Eita
AU - Momose, Haruka
AU - Hiradate, Yuki
AU - Mizukami, Takuo
AU - Hamaguchi, Isao
N1 - Funding Information:
The work discussed in this review was supported by a Health and Labor Sciences Research Grant (‘Adjuvant Database Project’) from the Japanese Ministry of Health, Labor, and Welfare, and by the Japan Agency for Medical Research and Development (AMED) under Grant Number JP18ak0101071 and JP18fk0108051.
Publisher Copyright:
© 2018 Elsevier Ltd
PY - 2018/11/12
Y1 - 2018/11/12
N2 - Vaccines effectively prevent infectious diseases. Many types of vaccines against various pathogens that threaten humans are currently in widespread use. Recently, adjuvant adaptation has been attempted to activate innate immunity to enhance the effectiveness of vaccines. The effectiveness of adjuvants for vaccinations has been demonstrated in many animal models and clinical trials. Although a highly potent adjuvant tends to have high effectiveness, it also has the potential to increase the risk of side effects such as pain, edema, and fever. Indeed, highly effective adjuvants, such as poly(I:C), have not been clinically applied due to their high risks of toxicity in humans. Therefore, the task in the field of adjuvant development is to clinically apply highly effective and non- or low-toxic adjuvant-containing vaccines. To resolve this issue, it is essential to ensure a low risk of side effects and the high efficacy of an adjuvant in the early developmental phases. This review summarizes the theory and history of the current safety assessment methods for adjuvants, using the inactivated influenza vaccine as a model. Our novel method was developed as a system to judge the safety of a candidate compound using biomarkers identified by genomic technology and statistical tools. A systematic safety assessment tool for adjuvants would be of great use for predicting toxicity during novel adjuvant development, screening, and quality control.
AB - Vaccines effectively prevent infectious diseases. Many types of vaccines against various pathogens that threaten humans are currently in widespread use. Recently, adjuvant adaptation has been attempted to activate innate immunity to enhance the effectiveness of vaccines. The effectiveness of adjuvants for vaccinations has been demonstrated in many animal models and clinical trials. Although a highly potent adjuvant tends to have high effectiveness, it also has the potential to increase the risk of side effects such as pain, edema, and fever. Indeed, highly effective adjuvants, such as poly(I:C), have not been clinically applied due to their high risks of toxicity in humans. Therefore, the task in the field of adjuvant development is to clinically apply highly effective and non- or low-toxic adjuvant-containing vaccines. To resolve this issue, it is essential to ensure a low risk of side effects and the high efficacy of an adjuvant in the early developmental phases. This review summarizes the theory and history of the current safety assessment methods for adjuvants, using the inactivated influenza vaccine as a model. Our novel method was developed as a system to judge the safety of a candidate compound using biomarkers identified by genomic technology and statistical tools. A systematic safety assessment tool for adjuvants would be of great use for predicting toxicity during novel adjuvant development, screening, and quality control.
KW - Adjuvant
KW - Biomarker
KW - Genomics
KW - Influenza vaccine
KW - Preclinical test
KW - Safety evaluation
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U2 - 10.1016/j.vaccine.2018.10.009
DO - 10.1016/j.vaccine.2018.10.009
M3 - Review article
C2 - 30318166
AN - SCOPUS:85054569742
VL - 36
SP - 7112
EP - 7118
JO - Vaccine
JF - Vaccine
SN - 0264-410X
IS - 46
ER -