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METHOD FOR ASSESSING SIDE REACTION RISK OF VACCINE

Foreign code F200010166
File No. (S2018-0905-N0)
Posted date Jun 3, 2020
Country WIPO
International application number 2019JP033742
International publication number WO 2020045509
Date of international filing Aug 28, 2019
Date of international publication Mar 5, 2020
Priority data
  • P2018-158968 (Aug 28, 2018) JP
Title METHOD FOR ASSESSING SIDE REACTION RISK OF VACCINE
Abstract To provide a method for assessing the likelihood of a side reaction of a vaccine. A method for assessing the likelihood of a side reaction of a vaccine, said method comprising: (a) a step for measuring microRNA expression level and snRNA expression level in extracellular vesicles sampled from a biological specimen, or measuring the ratio of expression levels of two different microRNAs or snRNAs; and (b) a step for predicting the onset risk of an autoimmune disease from the expression levels or ratio measured above, wherein the microRNA(s) and snRNA(s) are at least one member selected from among miR-16, miR-21, miR-451a and U6.
Outline of related art and contending technology BACKGROUND ART
Autoimmune disorders, immune system to recognize the extraneous foreign matter, recognizing its own component caused by the attack. To the central nervous system of an autoimmune disease or acute disseminated encephalomyelitis and such as multiple sclerosis, autoimmune diseases of the peripheral nerves guillain, the valleys of the syndrome and the like. Other tissue as autoimmune diseases, such as rheumatoid arthritis and I diabetes mellitus has been known.
Acute disseminated encephalomyelitis and guillain, autoimmune diseases of the nervous system such as a valley with respect to the syndrome, virus infection or may occur after vaccination. For example, dicaprate guillain virus infection, the valleys of the development of the causal relationship has been reported, as a side effect of the influenza vaccine or vaccine cervical cancer, acute disseminated encephalomyelitis and guillain, the valleys of the syndrome are reported to occur.
After infection and vaccination is an autoimmune disease, produced within the IL-1β, IL-6, such as inflammatory cytokine TNF-α, the blood-brain barrier disruption, T cells or dendritic cells immune cells and the like, from entering into the central nervous system is the main cause. This to the central nervous system as an animal model of autoimmune disease, experimental autoimmune encephalomyelitis (Experimental Autoimmune Encephalomyelitis: EAE) has been known (Non-Patent Document 1, Non-Patent Document 2). Mouse EAE model of autoimmune disease is an experimental system of the general experimental system has been widely used in the study as a.
Extracellular vesicles, vesicle release from various cells and, from the functional cell is transmitted to the cells of the microRNA. In vivo, various extracellular vesicles released from the cells, are enriched in bodily fluids such as blood. From cell to cell and the microRNA is transmitted, is taken into the cytoplasm and to inhibit target gene function, and cytokine production, by changing the amount of expression of other proteins, controls the functions of the various cells. Therefore, an extracellular vesicles, dendritic cells and T cells such as control the function of the immune system have been reported.
Acute disseminated encephalomyelitis and guillain, the risk of autoimmune diseases such as the valleys of the syndrome can be predicted, such as a vaccine of influenza vaccine or vaccination cervical cancer can be refrained. Also, like treatment with early viral infection, autoimmune disease can be preventing the onset.
Scope of claims (In Japanese)[請求項1]
  ワクチンの副反応の可能性を検査する方法であって、以下の工程:
  (a) 生体試料から採取された細胞外小胞内に含まれるマイクロRNA又はsnRNAの発現量、又は当該細胞外小胞内に含まれる異なる2つのマイクロRNA又はsnRNAの発現量の比を測定する工程、及び
  (b) 前記測定された発現量又は比から、前記副反応の発症リスクを予測する工程、
  を含み、
  前記マイクロRNA及びsnRNAが、miR-16、miR-21、miR-451a及びU6からなる群から選ばれる少なくとも1つである、前記方法。

[請求項2]
  ワクチンが、インフルエンザワクチン、子宮頸がんワクチン、肝炎ワクチン、日本脳炎ワクチン、狂犬病ワクチン及びウイルスの抗原を用いた不活化ワクチンからなる群から選ばれる少なくとも1つである、請求項1に記載の方法。

[請求項3]
  ワクチンの副反応が自己免疫疾患である、請求項1又は2に記載の方法。

[請求項4]
  自己免疫疾患が、急性散在性脳脊髄炎又はギラン・バレー症候群である、請求項3に記載の方法。

[請求項5]
  生体試料が血液、尿、汗又は唾液である請求項1~4のいずれか1項に記載の方法。

[請求項6]
  マイクロRNA及びsnRNAの発現量の比が、U6/miR-21及びmiR-16/miR-451aである、請求項1~5のいずれか1項に記載の方法。

[請求項7]
  U6/miR-21の値が高いときは、ワクチンの副反応のリスクが高いと判定し、及び/又はU6/miR-21の値が低いときは、ワクチンの副反応のリスクが少ないと判定する、請求項6に記載の方法。

[請求項8]
  miR-16/miR-451aの値が低いときは、ワクチンの副反応のリスクが高いと判定し、及び/又はmiR-16/miR-451aが高いときは、ワクチンの副反応のリスクが少ないと判定する、請求項6に記載の方法。

[請求項9]
miR-16、miR-21、miR-451a及びU6から選ばれる少なくとも1つのマイクロRNA又はsnRNAを含む、ワクチンの副反応マーカー。
  • Applicant
  • ※All designated countries except for US in the data before July 2012
  • NATIONAL UNIVERSITY CORPORATION KUMAMOTO UNIVERSITY
  • Inventor
  • OSHIUMI HIROYUKI
  • ISHIKAWA KANA
IPC(International Patent Classification)
Specified countries National States: AE AG AL AM AO AT AU AZ BA BB BG BH BN BR BW BY BZ CA CH CL CN CO CR CU CZ DE DJ DK DM DO DZ EC EE EG ES FI GB GD GE GH GM GT HN HR HU ID IL IN IR IS JO JP KE KG KH KN KP KR KW KZ LA LC LK LR LS LU LY MA MD ME MG MK MN MW MX MY MZ NA NG NI NO NZ OM PA PE PG PH PL PT QA RO RS RU RW SA SC SD SE SG SK SL SM ST SV SY TH TJ TM TN TR TT TZ UA UG US UZ VC VN ZA ZM ZW
ARIPO: BW GH GM KE LR LS MW MZ NA RW SD SL SZ TZ UG ZM ZW
EAPO: AM AZ BY KG KZ RU TJ TM
EPO: AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
OAPI: BF BJ CF CG CI CM GA GN GQ GW KM ML MR NE SN ST TD TG
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