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Establishment of a novel safety assessment method for vaccine adjuvant development

机译：建立一种疫苗辅助开发的新型安全评估方法

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摘要

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.
机译：疫苗有效预防传染病。威胁人类威胁人类的各种病原体的许多类型的疫苗目前普遍使用。最近，已经试图激活先天免疫以增强疫苗的有效性。在许多动物模型和临床试验中，已经证明了佐剂对疫苗接种的有效性。尽管高效的佐剂趋于具有高效性，但它也有可能增加疼痛，水肿和发烧等副作用的风险。实际上，由于人类毒性的高风险，因此，高效的佐剂，例如聚（i：c），尚未临床应用。因此，佐剂开发领域的任务是临床上施加高效和非含量或低毒的含助剂的疫苗。为了解决这个问题，必须确保副作用的低风险和佐剂在早期发育阶段的高效性。本综述总结了使用作为模型的灭活流感疫苗的佐剂当前安全评估方法的理论和历史。我们的新方法是用基因组技术和统计工具鉴定的生物标志物判断候选化合物的安全性的系统。用于佐剂的系统安全评估工具对于在新型佐剂开发，筛选和质量控制期间预测毒性很大。

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  • 来源
    《Vaccine》 |2018年第46期|共7页
  • 作者

    Eita Sasaki; Haruka Momose; Yuki Hiradate; Takuo Mizukami; Isao Hamaguchi;

  • 作者单位

    Department of Safety Research on Blood and Biological Products National Institute of Infectious Diseases;

    Department of Safety Research on Blood and Biological Products National Institute of Infectious Diseases;

    Department of Safety Research on Blood and Biological Products National Institute of Infectious Diseases;

    Department of Safety Research on Blood and Biological Products National Institute of Infectious Diseases;

    Department of Safety Research on Blood and Biological Products National Institute of Infectious Diseases;

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  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 医学免疫学;
  • 关键词

    Adjuvant; Influenza vaccine; Safety evaluation; Genomics; Biomarker; Preclinical test;

    机译：佐剂;流感疫苗;安全评估;基因组学;生物标志物;临床前测试;

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