JP2022153501A - 免疫不全患者の結核に関する皮膚検査 - Google Patents
免疫不全患者の結核に関する皮膚検査 Download PDFInfo
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Abstract
Description
1908年のロベルト・コッホによる発見以来、ツベルクリン精製タンパク質誘導物(PPD)は、潜在性Mtb感染症の診断検査として用いられてきた。
PPD TSTの使用に対する別の大きな課題は免疫不全者における信頼性の欠如である。特にヒト免疫不全ウイルス(HIV)感染者において、PPD TSTは無反応および偽陰性となることが多いか、もしくはあまりに低いカットオフ値の適用が原因で偽陽性になる場合がある。
上述のようにBCGと環境マイコバクテリアに対する交差反応性はPPD TSTの大きな制約となる。交差反応性は特異性を損ない、偽陽性反応による過剰治療をもたらす可能性がある。この特異性の問題は、TSTのカットオフ値を5mmから10mmもしくはさらに15mmの硬結に大きくすることによってある程度まで対処することができるが完全ではなく、カットオフ値を大きくすると検査の感度が損なわれる。
Mtb特異的免疫優性抗原の発見によってMtb感染症の診断のための重要な新規手段がもたらされた。初期の研究によって、PPD TSTをMtb抗原に対する反応におけるT細胞によるインターフェロンガンマ(IFN-γ)のin vitro産生を評価する検査で置き換える可能性が示された。同時期に、特異性を著しく改善した高い免疫原性を示す抗原、すなわち初期分泌抗原性標的-6(ESAT-6)および培養濾液タンパク質10(CFP-10)が発見されたことが大きな進歩であった。これらの抗原は病原体の変異領域1(region of difference 1)(RD1)内でコード化され、その結果全てのカルメット-ゲラン桿菌(BCG)ワクチン系統およびほとんどの非結核性マイコバクテリア(例外としてMycobacterium kansasii、Mycobacterium marinum、Mycobacterium szulgaiなどがある)に存在しない。
しかし、IGRAは特異性がTSTと比較して明らかに優れているにも関わらず、IGRAにはいくつか限界がある。
本発明は、免疫不全者もしくはHIVとの重感染者におけるMycobacterium tuberculosis感染症の存在のin vivoでの判定に用いるMtb抗原を含む組成物を開示するものであり、ここでこの薬剤はESAT6とCFP-10の2つの抗原のカクテルを含む。
用語「結核」は、種々の系統のマイコバクテリア、通常Mycobacterium tuberculosisによって引き起こされる臨床状態の結核疾患のことをいう。
皮膚検査は少量のC-Tbを皮内注射、例えば前腕の内表面に0.1ml注射することにより行われる。
特異的試薬を用いる皮膚検査は免疫抑制者に使用する場合特に有益である。HIVは、Mtb感染症が急速に活動性疾患に進行する可能性がある極めて重要なリスクの状態にある集団を構成する。HIV感染者はCD4T細胞機能不全であり、そのため試薬を用いる皮膚検査は特異的にTh1T細胞を標的とするが、Th2または調節T細胞も優れていることではない。
Claims (9)
- 試薬がESAT6およびCFP-10の2つの抗原のカクテルを含む免疫不全者もしくはHIVとの重感染者におけるMycobacterium tuberculosis(Mtb)感染症の存在のin vivo診断のためのMtb抗原を含む組成物。
- 例えばLactococcus lactis由来の適切な有機体中で前記2つの抗原をクローン化、産生および精製した請求項1に記載の免疫不全者もしくはHIVとの重感染者におけるMycobacterium tuberculosis感染症の存在のin vivo診断のためのMtb抗原を含む組成物。
- 前記試薬が前記2つの抗原rdESAT6およびrCFP-10のカクテルを含む請求項1~2のいずれか一項に記載の免疫不全者もしくはHIVとの重感染者におけるMycobacterium tuberculosis感染症の存在のin vivo診断のためのMtb抗原を含む組成物。
- 前記抗原が媒体中で混合される請求項3に記載の免疫不全者もしくはHIVとの重感染者におけるMycobacterium tuberculosis(Mtb)感染症の存在のin vivo診断のためのMtb抗原を含む組成物。
- rdESAT-6およびrCFP10を重量比1:1で混合する請求項4に記載の免疫不全者もしくはHIVとの重感染者におけるMycobacterium tuberculosis感染症の存在のin vivo診断のためのMtb抗原を含む組成物。
- 前記抗原の量が各抗原について0.25~2.0μg/mLである請求項5に記載の免疫不全者もしくはHIVとの重感染者におけるMycobacterium tuberculosis感染症の存在のin vivo診断のためのMtb抗原を含む組成物。
- 前記媒体が0.01%のポリソルベート20および0.5%のフェノールを含有するリン酸緩衝生理食塩水(PBS)を含む請求項4~6のいずれか一項に記載の免疫不全者もしくはHIVとの重感染者におけるMycobacterium tuberculosis感染症の存在のin vivo診断のためのMtb抗原を含む組成物。
- 前記2つの抗原ESAT6およびCFP-10のカクテルを少量皮内注射することによる免疫細胞の刺激に対する反応で生じる皮膚の反応の大きさを測定することによって免疫不全者もしくはHIVとの重感染者におけるMycobacterium tuberculosis(Mtb)感染症を診断する方法。
- 前記カクテルがC-Tbを含む請求項8に記載の免疫不全者もしくはHIVとの重感染者におけるMtb感染症を診断する方法。
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PCT/DK2016/050366 WO2017084671A1 (en) | 2015-11-18 | 2016-11-15 | Skin Testing for tuberculosis in immunocompromised persons |
JP2018525696A JP2018535977A (ja) | 2015-11-18 | 2016-11-15 | 免疫不全患者の結核に関する皮膚検査 |
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JP2022115760A Withdrawn JP2022153501A (ja) | 2015-11-18 | 2022-07-20 | 免疫不全患者の結核に関する皮膚検査 |
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EP1767937A1 (en) * | 2005-09-27 | 2007-03-28 | Institut National De La Sante Et De La Recherche Medicale (Inserm) | Method of diagnosis of tuberculosis related immune restoration syndrome (IRS) |
CN101455847A (zh) * | 2007-12-12 | 2009-06-17 | 中国人民解放军总医院第二附属医院 | Esat6和cfp10蛋白在制备用于鉴定诊断结核病的药物中的应用 |
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AGGERBECK H: "SAFETY OF ESAT-6", TUBERCULOSIS, vol. VOL:86, NR:5, JPN5018007935, September 2006 (2006-09-01), GB, pages 363 - 373, ISSN: 0005100623 * |
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Publication number | Publication date |
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PL3377097T3 (pl) | 2023-01-09 |
FI3377097T3 (fi) | 2023-01-13 |
EP3377097B1 (en) | 2022-10-19 |
ES2933035T3 (es) | 2023-01-31 |
HRP20221470T1 (hr) | 2023-01-06 |
RS63819B1 (sr) | 2023-01-31 |
PT3377097T (pt) | 2022-12-20 |
CA3006110A1 (en) | 2017-05-26 |
JP2018535977A (ja) | 2018-12-06 |
KR20180083898A (ko) | 2018-07-23 |
WO2017084671A1 (en) | 2017-05-26 |
ZA201803452B (en) | 2019-08-28 |
AU2016355638A1 (en) | 2018-07-05 |
EP3377097A1 (en) | 2018-09-26 |
CN108430501B (zh) | 2023-04-11 |
MX2018006129A (es) | 2019-08-12 |
EA201891129A1 (ru) | 2019-02-28 |
AU2016355638B2 (en) | 2023-02-02 |
US20190151479A1 (en) | 2019-05-23 |
US10786579B2 (en) | 2020-09-29 |
LT3377097T (lt) | 2022-12-12 |
DK3377097T3 (da) | 2022-12-19 |
CN108430501A (zh) | 2018-08-21 |
HUE060819T2 (hu) | 2023-04-28 |
BR112018009901A2 (pt) | 2018-11-06 |
SI3377097T1 (sl) | 2023-02-28 |
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