JP6999941B2 - 病原体からの免疫原性抗原同定および臨床的有効性との相関 - Google Patents
病原体からの免疫原性抗原同定および臨床的有効性との相関 Download PDFInfo
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Description
特定の実施形態において、本開示は、免疫原性であり、重要な治療応用形態がある、病原体(ウイルス、細菌もしくは真菌)および/またはがんに由来する抗原を同定するためのプロセスに関する。ある一定の態様において、このプロセスは、ウイルスなどの生物全体の一部またはすべてを、抗原として知られるフラグメントに区分すること、および有意な治療用抗原標的のランクを確立することを含む。次いで、この情報を使用して、ワクチン、養子細胞療法またはこれらの任意の組み合わせなどの処置の開発のために生物における特に有用なフラグメント(複数可)またはフラグメントの組み合わせを選択することができる。重要なこととして、このプロセスは、免疫原性抗原の同定を含み、したがって、エピトープ/HLA限定レベルで機能し得る以前の方法とは異なり、単一のHLA型に限定されない。
ヒトメタニューモウイルス(HMPV)は、乳児、高齢および易感染性個体における急性呼吸器疾患最も重要な原因因子である(Wen SCおよびWilliams JV、Clin.Vaccine Immunol. 2015)。
ヒトパラインフルエンザウイルス3型(PIV3)は、気道病原体であり、乳児および幼児における細気管支炎および肺炎の主原因である(Zvirbliene A.ら、Viral Immunology、2009)。低年齢小児に加えて、PIV3は、高齢者および易感染性成人を脅かす。PIV3感染症は、造血幹細胞移植(HSCT)を受ける患者の死(35%~75%)につながる重症疾患の原因にもなる(Nichols WGら、Blood、2001;Maziarz RTら、Biol Blood Marrow Transplant、2010;Sasaki Mら、Emerging Infect.Dis.、2013)
図18および22に示すように、ならびに一例として、IFNγ産生の閾値を使用してT細胞活性の臨界レベルを同定することができ、それを使用してレスポンダー対ノンレスポンダーを決定することができる。しかし、この閾値は、IFNγ産生のみに限定されるものではなく、この閾値の代わりに、例えばIL2、グランザイムB、CD25、GM-CSFおよびTNFαを含むがこれらに限定されない関連標的に関する認識に基づいてT細胞により産生される(細胞により分泌され、細胞培養物の上清から測定される場合のような)または発現される(細胞膜上に固定された不溶性マーカーの場合のような)任意の他の生物学的マーカーを用いることができることは、当業者には理解されるであろう。すべてのそのようなマーカーを使用して、非特異的応答の閾値を先ず同定することによりレスポンダー対ノンレスポンダーを決定することができる。非特異的応答のレベルは、無関係の抗原(例えば、初回T細胞刺激で使用しなかった抗原)に対して検出された生物学的活性の規模によって同定することができる。例えば、5つの抗原(A、B、C、D、E)をコードするウイルスへの免疫応答を分析する場合、無関係の抗原は、異なるウイルスに由来するまたは未操作PBMCに対する抗原Fとなる。これを、特定の実施形態において、IFNγについて2×105あたり20SFC、およびグランザイムBについて2×105あたり10SFCと決定した。図24は、病原体に対する免疫応答の特性解析のためにグランザイムBを使用してレスポンダーのノンレスポンダーに対する百分率を決定する例を示すものである。
TCスコアによって確立された階層の臨床的関連性を確認するために、本発明者らは、活動性感染症を有する患者におけるPIV3に対する免疫T細胞応答を分析した。図25に示すように、抗原MおよびNを標的とするPIV3特異的T細胞の出現頻度は、155日目と162日目の間で特定の高まりを示し、これは、167日目までに治まる臨床症状のその後の改善と相関する。ウイルス感染症を抑えるようなPIV3 T細胞の臨床的関連性のもう1つの例であって、PIV3特異的T細胞の出現頻度の増加に、骨髄移植(BMT)後の活動性感染症を有する1人の代表患者に存在する感染症の症状およびPCRによるウイルス検出との逆相関があった例を図26に示す。
[産物の組成]
(RTB)+(RTK)≧1を特徴とするin vitro T細胞と定義される産物は、様々な製造プロセスによって獲得することができる。後段の説明は、ある一定のT細胞が治療的に有用であるか否かの判定についての実施形態に関する。下記は、一部の製造実施例を表すものである:
によって定義され得るものであり、この式が、≧1である場合、産物を患者に投与し、この式が、<1である場合、投与しない。
Claims (10)
- 以下のステップを含む、病原体またはがんに対する抗原の免疫原性の階層の確立のための方法:
複数の個体から得られたそれぞれの末梢血単核細胞(PBMC)を、以下の(a)~(e)を含むin vitroの培養条件下で培養するステップ;
(a)1個体に由来する前記細胞を、病原体またはがんに由来する2以上の抗原に、
1以上のTh1サイトカインの存在下で、前記抗原を認識する細胞の量的な増殖を可能ならしめる条件下で曝露して、増殖した細胞を作製すること、
(b)増殖した前記細胞を複数の別々の培養物に分けて、それぞれの培養物で別々の前記抗原の1つを添加すること、
(c)増殖した前記細胞の別々の培養物のそれぞれから判定された生物学的活性の大きさを閾値と比較して、レスポンダーである増殖した細胞培養物とノンレスポンダーである増殖した細胞培養物とを判別すること、
(d)前記生物学的活性が前記閾値を超えた場合は増殖した細胞培養物をレスポンダーと同定し、前記生物学的活性が前記閾値を超えない場合は細胞培養物をノンレスポンダーと同定すること、
(e)複数の個体から得られたPBMCについて前記(a)~(d)を行い、前記2以上の抗原のそれぞれについて、評価した個体の数に対して、前記増殖した細胞培養物がレスポンダーである頻度及び前記増殖した細胞培養物がノンレスポンダーである頻度を決定すること、及び
(f)以下の数式:
ここで、前記生物学的活性が、IFNγ及び/又はグランザイムBの産生を含む。 - 前記病原体が、ウイルス、真菌または細菌である、請求項1に記載の方法。
- 前記閾値を決定するステップをさらに含む、請求項1または2に記載の方法。
- 前記ウイルスが、呼吸器ウイルスである、請求項2または3に記載の方法。
- 前記呼吸器ウイルスが、パラインフルエンザウイルスまたはメタニューモウイルスである、請求項4に記載の方法。
- 前記パラインフルエンザウイルスが、III型である、請求項5に記載の方法。
- 前記メタニューモウイルスが、ヒトメタニューモウイルスである、請求項5に記載の方法。
- 前記階層の情報が、前記病原体に曝露された、前記病原体に曝露されるリスクがある、前記病原体に罹患しやすい、前記病原体からの疾患を有する、前記がんのリスクがある、または前記がんを有する個体に対する免疫療法の決定に用いられる、請求項1~7のいずれか一項に記載の方法。
- 前記免疫療法が、ワクチン、免疫原性組成物、モノクローナル抗体、二重特異性T細胞エンゲージャー(BiTE)、腫瘍溶解性ウイルス、養子T細胞移植、またはこれらの組み合わせを含む、請求項8に記載の方法。
- 前記免疫療法が、同じ細胞上の1つより多くの抗原を標的にする、請求項8または9に記載の方法。
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AU2016324479B2 (en) | 2022-12-01 |
AU2022268286A1 (en) | 2022-12-15 |
EP3350600A1 (en) | 2018-07-25 |
CN108449994B (zh) | 2021-10-01 |
US20180250384A1 (en) | 2018-09-06 |
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IL258090B (en) | 2022-12-01 |
EP4290238A2 (en) | 2023-12-13 |
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JP2024045272A (ja) | 2024-04-02 |
AU2016324479A1 (en) | 2018-04-12 |
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