JP5588990B2 - 機械的表皮破壊を介したポックスウイルスベクターによるワクチン接種 - Google Patents
機械的表皮破壊を介したポックスウイルスベクターによるワクチン接種 Download PDFInfo
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Description
本発明は、一部、国立衛生研究所(National Institute of Health (NIH))の国立アレルギー感染症研究所(National Institute of Allergy and Infectious Diseases (NIAID))によって与えられた交付金番号U19 AI057330および5U54AI057159−05のもとで政府支援によってなされた。米国政府は本発明に対し一定の権利を有する。
ワクチンは伝統的に、弱毒化された生の病原体、全不活化生物または不活化毒素からなっていた。多くの場合、これらのアプローチは、抗体媒介応答に基づいた免疫防御を誘導することに成功してきた。しかし、ある種の病原体、例えば、HIV、HCV、TB、マラリアおよびがんは細胞媒介免疫(CMI)の誘導が必要である。非生ワクチンは、一般に、CMIを生み出すことには無効であることが判明している。さらに、生ワクチンはCMIを誘導し得るが、一部の弱毒化生ワクチンは免疫抑制被験体に疾患を引き起こすことがある。
改変ワクシニアウイルスAnkara(MVA)株などの弱毒化複製欠損性ワクシニアウイルスは、目覚ましい安全性および免疫原性プロファイルを有するので有望な生ウイルスワクチンベクターとして既に提案されており、前臨床試験でも臨床試験でも試されてきた。しかし、MVAなどのウイルスワクチンは、これまで注射経路を介してのみ投与され、現在まで皮膚乱切(skin scarification)を介して投与されることはなかった。これは、ポックス病変の発生およびそれに続く抗原チャレンジ(challenge)に対する強力な防御には表皮中でのウイルス複製が必要であるという仮定によるだろう。にもかかわらず、発明者らは皮膚乱切を介してマウスをMVAで免疫化し、驚いたことに、MVA皮膚乱切は用量依存様式で特徴的なポックス病変を誘導し、ワクシニアウイルス(VV)抗原に対する用量依存的細胞性および体液性免疫応答を生み出した。どんな特定の機構または理論にも縛られるつもりはないが、発明者らは、皮膚乱切を介した免疫化により強力な免疫応答を誘発するのにウイルス複製は必要ではないと考えている。
本発明はまた、以下の項目を提供する。
(項目1)
免疫応答を刺激するための方法であって、上記免疫応答を刺激するのに十分な量で抗原を含む生の改変された非複製性または複製障害性ポックスウイルスを被験体に投与することを含み、上記ポックスウイルスは機械的に破壊された表皮に投与される、方法。
(項目2)
上記免疫応答が体液性応答および/または細胞性応答である、項目1に記載の方法。
(項目3)
上記細胞性応答がCD4+T細胞および/またはCD8+T細胞および/またはB細胞により誘発される、項目2に記載の方法。
(項目4)
上記ポックスウイルスが、オルソポックス、スイポックス、トリポックス、カプリポックス、レポリポックス、パラポックスウイルス、伝染性軟属腫ウイルス、およびヤタポックスウイルスからなる群より選択される、項目1に記載の方法。
(項目5)
上記オルソポックスウイルスがワクシニアウイルスである、項目4に記載の方法。
(項目6)
上記ワクシニアウイルスが、改変ワクシニアウイルスAnkara(MVA)、WR株、NYCBH株、Wyeth株、ACAM2000、Lister株、LC16m8、Elstree−BNm、Copenhagen株、およびTiantan株からなる群より選択される、項目5に記載の方法。
(項目7)
上記表皮が、乱切針、皮下針、または擦過器により機械的に破壊される、項目1に記載の方法。
(項目8)
上記表皮が、上記ポックスウイルスの投与と本質的に同時に機械的に破壊される、項目1に記載の方法。
(項目9)
上記表皮が、上記ポックスウイルスの投与前に機械的に破壊される、項目1に記載の方法。
(項目10)
上記被験体が、がんを有するかまたはがんを発症する危険がある、項目1に記載の方法。
(項目11)
上記がんが、皮膚がん、乳がん、前立腺がん、肺がん、脳がん、肺がん、卵巣がん、肝臓がん、膵臓がん、胃がん、腎臓がん、膀胱がん、および甲状腺がんまたは結腸直腸がんである、項目10に記載の方法。
(項目12)
上記がんが、前立腺腺癌、前立腺上皮新形成、肺扁平上皮癌、肺腺癌、小細胞肺癌、上皮由来の卵巣がん、結腸直腸腺癌および平滑筋肉種、胃腺癌および平滑筋肉腫、肝細胞癌、胆管癌、膵臓の管腺癌、膵内分泌部腫瘍、腎細胞癌、腎臓および膀胱の移行上皮癌、膀胱扁平上皮癌、乳頭様甲状腺がん、濾胞性甲状腺がん、星状細胞腫、ならびに多形神経膠芽腫からなる群より選択される、項目11に記載の方法。
(項目13)
上記皮膚がんが、メラノーマ、皮膚扁平上皮癌および基底細胞癌からなる群より選択される、項目11に記載の方法。
(項目14)
上記被験体が感染を有するかまたは感染を発症する危険がある、項目1に記載の方法。
(項目15)
上記感染が、ウイルス感染、細菌感染、真菌感染、または原虫感染である、項目14に記載の方法。
(項目16)
上記ウイルス感染が、HIV、インフルエンザ、デング熱、A型肝炎ウイルス、B型肝炎ウイルス、C型肝炎ウイルス、ヒトパピローマウイルス、エボラ、マールブルグ、狂犬病、ハンタウイルス感染、ウエストナイルウイルス、SARS様コロナウイルス、単純ヘルペスウイルス、水痘帯状疱疹ウイルス、エプスタインバーウイルス、ヒトヘルペスウイルス8型、アルファウイルス、およびセントルイス脳炎からなる群より選択される、項目15に記載の方法。
(項目17)
上記細菌感染が、Mycobacterium tuberculosis、Salmonella typhi、Bacillus anthracis、Yersinia
perstis、Francisella tularensis、Legionella、Chlamydia、Rickettsia typhi、およびTreponema pallidumからなる群より選択される、項目15に記載の方法。
(項目18)
上記真菌感染が、Coccidioides immitis、Blastomyces dermatitidis、Cryptococcus neoformans、Candida albicans、およびAspergillus種からなる群より選択される、項目15に記載の方法。
(項目19)
上記原虫感染が、Malaria(Plasmodium falciparum、Plasmodium vivax、Plasmodium ovale、Plasmodium malariae)、Leishmania種、Trypanosome種(アフリカおよびアメリカ)、クリプトスポリジウム、イソスポラ種、Naegleria fowleri、Acanthamoeba種、Balamuthia mandrillaris、Toxoplasma gondii、およびPneumocystis cariniiからなる群より選択される、項目15に記載の方法。
(項目20)
上記抗原が、腫瘍関連抗原(TAA)、腫瘍特異抗原(TSA)、または組織特異抗原である、項目1に記載の方法。
(項目21)
上記抗原が、ウイルス抗原、細菌抗原、真菌抗原または原虫抗原である、項目1に記載の方法。
(項目22)
共刺激分子、増殖因子、アジュバンドおよび/またはサイトカインを投与することをさらに含む、項目1に記載の方法。
(項目23)
上記共刺激分子が、上記ポックスウイルスにより上記抗原と共発現される、項目22に記載の方法。
(項目24)
上記共発現される共刺激分子が、IL−1、IL−2、IL−7、IL−12、IL−15、IL−18、IL−23、IL−27、B7−2、B7−H3、CD40、CD40L、ICOS−リガンド、OX−40L、4−1BBL、GM−CSF、SCF、FGF、Flt3−リガンド、CCR4からなる群より選択される、項目23に記載の方法。
(項目25)
上記ポックスウイルスがTRICOM TM である、項目1に記載の方法。
(項目26)
上記共刺激分子、増殖因子、アジュバンドおよび/またはサイトカインが、上記抗原と本質的に同時に投与される、項目22に記載の方法。
(項目27)
上記共刺激分子、増殖因子、アジュバンドおよび/またはサイトカインが、上記抗原の前に投与される、項目22に記載の方法。
(項目28)
上記共刺激分子、増殖因子、アジュバンドおよび/またはサイトカインが、上記抗原の後で投与される、項目22に記載の方法。
(項目29)
上記共刺激分子、増殖因子、アジュバンドおよび/またはサイトカインが、上記抗原と本質的に同じ部位に投与される、項目26〜28のいずれか一項に記載の方法。
(項目30)
上記共刺激分子、増殖因子、アジュバンドおよび/またはサイトカインが、上記抗原とは異なる部位に投与される、項目26〜28のいずれか一項に記載の方法。
(項目31)
上記抗原の第1の投与後のある時期における、上記抗原の第2の投与をさらに含む、項目1に記載の方法。
(項目32)
上記非複製性または複製障害性ポックスウイルスが、上記抗原をコードする核酸を含むウイルスベクターを含む、項目1に記載の方法。
(項目33)
上記抗原をコードする上記核酸がプロモーターに作動可能に連結されている、項目32に記載の方法。
(項目34)
上記プロモーターが、構成的に活性であるプロモーターまたは誘導性プロモーターである、項目33に記載の方法。
(項目35)
エンハンサーまたは他の転写調節エレメント(TRE)をさらに含む、項目33に記載の方法。
(項目36)
上記被験体が、上記抗原を含む上記ポックスウイルスの投与に先立って上記抗原でチャレンジされておらず、上記被験体が上記抗原でチャレンジされる危険がある、項目1に記載の方法。
(項目37)
上記免疫応答を刺激することが、上記抗原を提示する作用因子により引き起こされる疾患に対する上記被験体の防御を与える、項目36に記載の方法。
(項目38)
上記被験体が、上記抗原を含む上記ポックスウイルスの投与に先立って上記抗原でチャレンジされている、項目1に記載の方法。
(項目39)
上記免疫応答を刺激することが、上記抗原を提示する作用因子により引き起こされる上記被験体の疾患を処置する、項目38に記載の方法。
(項目40)
上記疾患が感染またはがんである、項目37または39に記載の方法。
(項目41)
上記がんが、メラノーマ、皮膚扁平上皮癌、基底細胞癌、乳がん、前立腺腺癌、前立腺上皮新形成、肺扁平上皮癌、肺腺癌、小細胞肺癌、上皮由来の卵巣がん、結腸直腸腺癌および平滑筋肉腫、胃腺癌および平滑筋肉腫、肝細胞癌、胆管癌、膵臓の管腺癌、膵内分泌部腫瘍、腎細胞癌、腎臓および膀胱の移行上皮癌、膀胱扁平上皮癌、乳頭様甲状腺がん、濾胞性甲状腺がん、星状細胞腫、および多形神経膠芽腫からなる群より選択される、項目40に記載の方法。
(項目42)
上記感染が、ウイルス感染、細菌感染、真菌感染、または原虫感染である、項目40に記載の方法。
(項目43)
感染が、HIV、インフルエンザ、デング熱、A型肝炎ウイルス、B型肝炎ウイルス、C型肝炎ウイルス、ヒトパピローマウイルス、エボラ、マールブルグ、狂犬病、ハンタウイルス感染、ウエストナイルウイルス、SARS様コロナウイルス、単純ヘルペスウイルス、水痘帯状疱疹ウイルス、エプスタインバーウイルス、ヒトヘルペスウイルス8型、アルファウイルス、セントルイス脳炎、Mycobacterium tuberculosis、Salmonella typhi、Bacillus anthracis、Yersinia perstis、Francisella tularensis、Legionella、Chlamydia、Rickettsia typhi、Treponema pallidum、Coccidioides immitis、Blastomyces dermatitidis、Cryptococcus neoformans、Candida albicans、Aspergillus種、Malaria(Plasmodium falciparum、Plasmodium vivax、Plasmodium ovale、Plasmodium malariae)、Leishmania種、Trypanosome種(アフリカおよびアメリカ)、クリプトスポリジウム、イソスポラ種、Naegleria fowleri、Acanthamoeba種、Balamuthia mandrillaris、Toxoplasma gondii、およびPneumocystis cariniiからなる群より選択される、項目42に記載の方法。
(項目44)
被験体の上皮を破壊するためのデバイスおよび生の改変された非複製性または複製障害性ポックスウイルスを含むキット。
(項目45)
上記デバイスが、乱切針、皮下針または擦過デバイスである、項目44に記載のキット。
(項目46)
上記ポックスウイルスが上記デバイスに付着している、項目44に記載のキット。
(項目47)
上記ポックスウイルスが溶液中に混合されている、項目44に記載のキット。
(項目48)
上記溶液が、被験体への上記ポックスウイルスの送達を増強する作用因子をさらに含み、上記ポックスウイルスが上記被験体の表皮を介して送達される、項目47に記載のキット。
(項目49)
上記溶液が、被験体における免疫応答を増強する作用因子をさらに含み、上記免疫応答が上記ポックスウイルスにより刺激される、項目47に記載のキット。
(項目50)
上記キットを使用するための説明書をさらに含む、項目44に記載のキット。
本発明の態様は、一部には、抗原に対する強力で持続性のある免疫応答は、抗原を含有する改変された複製欠損性または非複製性ポックスウイルスを被験体の機械的に破壊された表皮に投与することにより実現することができるという発見に基づいている。
本明細書には、感染(もしくは感染性疾患)またはがんに対して免疫応答を刺激するおよび/または被験体を免疫化するための新規の方法が提供される。該方法は、抗原に対する免疫応答を刺激するのに十分な量で、抗原を含有する改変された複製欠損性または非複製性ポックスウイルスベクターをそれを必要とする被験体に投与することを含み、ここでポックスウイルスは、被験体の機械的に破壊された表皮に投与される。
ポックスウイルスは、様々な使用、例えば、免疫応答を生み出すワクチンに、新しいワクチンの開発に、所望のタンパク質の送達におよび遺伝子治療に有用なベクターである。これらのポックスウイルスベクターの利点には、(i)生成および作製の容易さ、(ii)複数の遺伝子の挿入を可能にする(すなわち、多価ベクターとしての)大きなサイズのゲノム、(iii)抗原提示細胞を含む複数の細胞型への遺伝子の効率的送達、(iv)高レベルのタンパク質発現、(v)免疫系への抗原の最適な提示、および(vi)細胞媒介免疫応答および抗体応答を誘発する能力、(vii)免疫学的に交差反応性ではないために、異なる属由来のポックスウイルスの組合せを使用する能力、および(viii)このベクターをヒトにおいて痘瘡ワクチンとして使用してきたことで得られた長期の経験が挙げられる。
いくつかの実施形態では、遺伝子をコードする少なくとも1つの核酸断片がポックスウイルスベクターに挿入される。別の実施形態では、異なる遺伝子をコードする少なくとも2つおよび最大約10の異なる核酸がポックスウイルスベクターに挿入される。
目的の抗原をコードする遺伝子は、細菌宿主に該遺伝子をクローニングすることにより増幅することが可能である。この目的のために、様々な原核生物クローニングベクターを使用することができる。例は、プラスミドpBR322およびpEMBLである。
本明細書に記載されているように、本明細書に提供されるポックスウイルスベクターは、抗原性または免疫原性断片(抗原)をコードしている。目的の抗原は、病原性微生物由来の抗原または腫瘍(もしくはがん)抗原であることが可能である。抗原をコードする遺伝子または核酸断片は、細菌、ウイルス、真菌、原虫、寄生生物、正常もしくは形質転換された細胞、または他の微生物を含む、どんな生物由来でも可能である。
いくつかの実施形態では、目的の遺伝子は、腫瘍関連抗原(TAA)、腫瘍特異抗原(TSA)、組織特異抗原、ウイルス腫瘍抗原、細胞発癌遺伝子タンパク質、および/または腫瘍関連分化抗原をコードする遺伝子である。
いくつかの重要な実施形態では、抗原性または免疫原性タンパク質断片またはエピトープは、HIV、インフルエンザ、デング熱、A型肝炎ウイルス、B型肝炎ウイルス、C型肝炎ウイルス、ヒトパピローマウイルス、エボラ、マールブルグ、狂犬病、ハンタウイルス感染、ウエストナイルウイルス、SARS様コロナウイルス、単純ヘルペスウイルス、水痘帯状疱疹ウイルス、エプスタインバーウイルス、ヒトヘルペスウイルス8型、アルファウイルスまたはセントルイス脳炎などの病原性ウイルス由来でよい。
ある種の実施形態では、抗原断片をコードする組換えポックスウイルスは、例えば、T細胞共刺激因子および/またはインターロイキン(IL)(例えば、IL−2、IL−4、IL−10、IL−12)、インターフェロン(IFN)(例えば、IFN−γ)、顆粒球マクロファージコロニー刺激因子(GM−CSF)またはアクセサリー分子(例えば、ICAM−1)などのサイトカインをコードするDNAなどの免疫調節因子を含むようにさらに改変される。ポックスウイルスベクターなどのかかる多価ベクターの構築は、本開示に基づく当分野の技術レベルの範囲内である。いくつかの場合、多価ベクターによるT細胞共刺激因子などの免疫調節剤および抗原の共発現が望ましいこともある。例えば、ワクチン有効性をブーストする免疫調節因子の実質的に純粋な調製物を投与することが望ましいこともある。
標的宿主細胞に送達される遺伝子を保有するウイルスベクターの導入は、当業者に公知の任意の方法によってもたらすことができる。
免疫応答を決定するための方法は、当技術分野で公知である。いくつかの実施形態では、ウイルス性病変を試験して、ウイルスおよび/または抗原への免疫応答の発生を決定することができる。いくつかの実施形態では、インビトロのアッセイを使用して、免疫応答の発生を決定することができる。かかるインビトロのアッセイの例には、ELISAアッセイおよび細胞傷害性T細胞(CTL)アッセイが挙げられる。いくつかの実施形態では、処置していない被験体における抗体の量と比較した、生の改変した非複製性または複製障害性ポックスウイルス(抗原を含む)を投与することによって処置した被験体の血清中の抗原を特異的に認識する抗体の相対量を検出および/または定量化することによって、免疫応答を測定する。
皮膚は、高濃度の抗原提示細胞(APC)、APC前駆体およびこの組織内で見出される免疫細胞のために、抗原の送達に魅力的な標的部位に相当し、増強した保護的免疫応答が生じる。ワクシニア遺伝子に対する比類なき強い免疫応答をもたらす、ワクシニアウイルスによるケラチノサイトの自然の感染工程を再現することにより、本明細書に記載の方法は、他のウイルス、細菌、真菌およびがん抗原などの、本明細書で提供されるポックスウイルスによって発現される異種抗原に対する被験体の免疫力を同様に増強する。結果として生じる免疫応答は、免疫化した被験体を保護でき、または被験体が既に疾患を発症していれば、抗原提示因子によって引き起こされる疾患の緩和また処置に役立ち得る。
本発明は、キットの使用も企図する。本発明の1つの態様では、ポックスウイルスおよび/またはその組成物を含む、薬学的パックまたはキットが提供される。1つの実施形態では、1つまたは複数の次の成分で満たした1つまたは複数の容器を含むキットが提供される:塩として乾燥させた形態(例えば、凍結乾燥)または溶液のいずれかで、抗原を含み、場合によっては共刺激分子を含む、生の改変された非複製性または複製障害性ポックスウイルス、場合によっては塩として乾燥した形態(例えば、凍結乾燥)または溶液のいずれかで、共刺激分子を含む第2ウイルス、場合によってはウイルス(複数可)を溶解または混合するための溶液またはゲル、および場合によってはアジュバント。いくつかの実施形態では、キットは、その上、表皮を破壊するためのデバイスを含む。かかるキットに付随するものは、キットの使い方についての説明書、および場合によっては医薬品または生物学的製品の製造、使用または販売を規制する行政機関によって規定された形態の通知書であってよく、該通知書は、ヒトへの投与のための製造、使用または販売に関する機関による承認を反映する。
本明細書に記載の疾患を処置または予防するための方法は、追加の作用剤を投与するステップを含むことができる。したがって、いくつかの実施形態では、本明細書に記載のがんを処置または予防するための方法(複数可)は、1つまたは複数の抗がん剤と組み合わせて使用することができる。本明細書に記載の薬学的組成物および投薬形態およびキットを含む、様々な実施形態で使用できる抗がん薬の例には、これに限定されないが、アシビシン;アクラルビシン;アコダゾルハイドロクロライド;アクロニン;アドゼレシン;アルデスロイキン;アルトレタミン;アンボマイシン;アメタントロンアセテート;アミノグルテチミド;アムサクリン;アナストロゾール;アンスラマイシン;アスパラギナーゼ;アスペルリン;アザシチジン;アゼテパ;アゾトマイシン;バチマスタット;ベンゾデパ;ビカルタミド;ビサントレンハイドロクロライド;ビスナフィドジメシレート;ビセレシン;ブレオマイシンサルフェート;ブレクイナルナトリウム;ブロピリミン;ブスルファン;カクチノマイシン;カルステロン;カプシタビン;カラセミド;カルベチメル;カルボプラチン;カルムスチン;カルビシンハイドロクロライド;カルゼレシン;セデフィンゴル;クロラムブシル;シロレマイシン;シスプラチン;クラドリビン;クリスナトールメシレート;シクロホスファミド;シタラビン;ダカルバジン;ダクチノマイシン;ダウノルビシンハイドロクロライド;デシタビン;デキソーマプラチン;デザグアニン;デアグアニンメシレート;ジアジクオン;ドセタキセル;ドキソルビシン;ドキソルビシンハイドロクロライド;ドロロキシフェン;ドロロキシフェンシトレート;ドロモスタノロンプロピオネート;デュアゾマイシン;エダトレキサート;エフロールニチンハイドロクロライド;エルサミトルシン;エンロプラチン;エンプロメート;エピプロピジン;エピルビシンハイドロクロライド;エルブロゾール;エソルビシンハイドロクロライド;エストラムスチン;エストラムスチンホスフェートナトリウム;エタニダゾール;エトポシド;エトポシドホスフェート;;エトプリン;ファドロゾールハイドロクロライド;ファザラビン;フェンレチニド;フロクスウリジン;フルダラビンホスフェート;フルオロウラシル;フルロシタビン;フォスクイドン;フォストリエシンナトリウム;ゲムシタビン;ゲムシタビンハイドロクロライド;ヒドロキシ尿素;イダルビシンハイドロクロライド;イホスファミド;イルモフォシン;インターロイキン(interleulin)II(組換えインターロイキンIIまたはrIL2が挙げられる);インターフェロンアルファ2a;インターフェロンアルファ2b;インターフェロンアルファn1;インターフェロンアルファn3;インターフェロンベータIa;インターフェロンガンマIb;イプロプラチン;イリノテカンハイドロクロライド;ランレオチドアセテート;レトロゾール;リュープロリドアセテート;リアロゾールハイドロクロライド;ロメトレキソールナトリウム;ロムスチン;ロソキサントロンハイドロクロライド;マソプロコール;マイタンシン;メクロレタミン;メクロレタミンオキシドハイドロクロライド;レサミンハイドロクロライド;メゲストロールアセテート;メレンゲストロールアセテート;メルファラン;メノガリル;メルカプトプリン;メトトレキサート;メトトレキサートナトリウム;メトプリン;メチュレデパ;ミチンドミド;マイトカルシン;マイトクロミン;マイトギリン;マイトマルシン;マイトマイシン;ミトスペル;ミトタン;ミトキサントロンハイドロクロライド;ミコフェノール酸;ノコダゾール;ノガラマイシン;オルマプラチン;オキシスラン;パクリタキセル;ペガスパルガーゼ;ペリオマイシン;ペンタムスチン;ペプロマイシンサルフェート;ペルフォスファミド;ピポブロマン;ピポスルファン;ピロクサントロンハイドロクロライド;プリカマイシン;プロメスタン;ポルフィマーナトリウム;ポルフィロマイシン;プレドニムスチン;プロカルバジンハイドロクロライド;ピューロマイシン;ピューロマイシンハイドロクロライド;ピラゾフリン;リボプリン;ログレチミド;サフィンゴール;サフィンゴールハイドロクロライド;セムスチン;シムトラゼン;スパルフォセートナトリウム;スパルソマイシン;スピロゲルマニウムハイドロクロライド;スピロムスチン;スピロプラチン;ストレプトニグリン;ストレプトゾシン;スロフェヌル;タリソマイシン;テコガランナトリウム;テガフール;テロクサントロンハイドロクロライド;テモポルフィン;テニポシド;テロキシロン;テストラクトン;チアミプリン;チオグアニン;チオテパ;チアゾフリン;チラパザミン;トレミフェンシトレート;トレストロンアセテート;トリシリビンホスフェート;トリメトレキセート;トリメトレキセートグルクロネート;トリプトレリン;チュブロゾールハイドロクロライド;ウラシルマスタード;ウレデパ;バプレオチド;ベルテポルフィン;ビンブラスチンサルフェート;ビンクリスチンサルフェート;ビンデシン;ビンデシンサルフェート;ビネピジンサルフェート;ビングリシネートサルフェート;ビンレウロシンサルフェート;ビノレルビンタルトレート;ビンロシジンサルフェート;ビンゾリジンサルフェート;ボロゾール;ゼニプラチン;ジノスタチン;ゾルビシンハイドロクロライド、インプロスルファン、ベンゾデパ、カルボコン、トリエチレンメラムリン、トリエチレンホスホルアミド、トリエチレンチオホスホルアミド、トリメチロールオメライニン(trimethylolomelainine)、クロマファジン、ノベムビチン、フェネステリン、トロホスファミド、エステルムスチン、クロロゾトシン、ゲムザル、ニムスチン、ラニムスチン、ダカルバジン、マンノムスチン、ミトブロニトール、アクラシノマイシン、アクチノマイシンF(1)、アザセリン、ブレオマイシン、カルビシン、カルジノフィリン、クロモマイシン、ダウノルビシン、ダウノマイシン、6−ジアゾ−5−オキソ−1−ノルロイシン、ドキソルビシン、オリボマイシン、プリカマイシリ、ポルフィロマイシン、ピューロマイシン、チュベルシジン、ゾルビシン、デノプテリン、プテロプテリン、6−メルカプトプリン、アンシタビン、6−アザウリジン、カルモフール、シタラビン、ジデオキシウリジン、エノシタビン、プルモジム、アセグラトン、アルドホスファミドグリコシド、ベストラブシル、デフォファミド、デメコルチン、エルフォルニチン、エリプチニウムアセテート、エトグルシド、フルタミド、ヒドロキシ尿素、レンチナン、フェナメット、ポドフィリン酸、2−エチルヒドラジド、ラゾキサン、スピロゲルマニウム、タモキシフェン、タキソテレ、テヌアゾン酸、トリアジコン、2,2’,2’’−トリクロロトリエチルアミン、ウレタン、ビンブラスチン、ビンクリスチン、ビンデシンおよび関連する薬剤、20−エピ−1,25ジヒドロキシビタミンD3;5−エチニルウラシル;アビラテロン;アクラルビシン;アシルフルベン;アデシペノール;アドゼレシン;アルデスロイキン;ALL−TKアンタゴニスト;アルトレタミン;アンバムスチン;アミドックス;アミホスチン;アミノレブリン酸;アムルビシン;アムサクリン;アナグレリド;アナストロゾール;アンドログラホリド;血管新生インヒビター;アンタゴニストD;アンタゴニストG;アンタレリックス;抗背側化形態形成タンパク質1;抗アンドロゲン、前立腺癌;抗エストロゲン剤;抗ネオプラストン;アンチセンスオリゴヌクレオチド;アフィディコリングリシネート;アポトーシス遺伝子調節因子;アポトーシス制御因子;アプリン酸;アラCDP−DL−PTBA;アルギニン脱アミノ酵素;アスラクリン;アタメスタン;アトリムスチン;アクシナスタチン1;アクシナスタチン2;アクシナスタチン3;アザセトロン;アザトキシン;アザチロシン;バッカチンIII誘導体;バラノール;バチマスタット;BCR/ABLアンタゴニスト;ベンゾクロリン;ベンゾイルスタウロスポリン;ベータラクタム誘導体;ベータアレチン;ベータクラマイシンB;ベツリン酸;bFGFインヒビター;ビカルタミド;ビサントレン;ビサジリジニルスペルミン;ビスナフィド;ビストラテンA;ビゼレシン;ブレフレート;ブロピリミン;ブドチタン;ブチオニンスルホキシミン;カルシポトリオール;カルフォスチンC;カンプトテシン誘導体;カナリポックスIL−2;カペシタビン;カルボキサミドアミノトリアゾール;カルボキシアミドトリアゾール;CaRest M3;CARN700;軟骨由来のインヒビター;カルゼレシン;カゼインキナーゼインヒビター(ICOS);カスタノスペルミン;セクロピンB;セトロレリックス;クロールリン;クロロキノキサリンスルホンアミド;シカプロスト;シスポルフィリン;クラドリビン;クロミフェン類似体;クロトリマゾール;コリスマイシンA;コリスマイシンB;コンブレタスタチンA4;コンブレタスタチン類似体;コナゲニン;クラムベスシジン816;クリスナトール;クリプトフィシン8;クリプトフィシンA誘導体;クラシン A;シクロペンタンスラキノン;シクロプラタム;シペマイシン;シタラビンオクフォスフェート;細胞溶解性因子;サイトスタチン;ダクリキシマブ;デシタビン;デヒドロジデムニンB;デスロレリン;デキサメサゾン;デキシフォスファミド;デクスラゾキサン;デキシベラパミル;ジアジクオン;ジデムニンB;ジドックス;ジエチルノルスペルミン;ジヒドロ−5−アザシチジン;ジヒドロタキソール、9−;ジオキサマイシン;ジフェニルスピロムスチン;ドセタキセル;ドコサノール;ドラセトロン;ドキシフルリジン;ドロロキシフェン;ドロナビノール;デュオカルマイシンSA;エブセレン;エコムスチン、エデルフォシン;エドレコロマブ;エフロールニチン;エレメン;エミテフル;エピルビシン;エプリステリド;エストラムスチン類似体;エストロゲンアゴニスト;エストロゲンアンタゴニスト;エタニダゾール;エトポシドホスフェート;エキセメスタン;ファドロゾール;ファザラビン;フェンレチニド;フィルグラスチム;フィナステリド;フラボピリドール;フレゼラスチン;フルアステロン;フルダラビン;フルオロダウノルニシンハイドロクロライド;ホルフェニメックス;ホルメスタン;ホストリエシン;ホテムスチン;ガドリニウムテクサフィリン;ガリウムニトレート;ガロシタビン;ガニレリックス;ゼラチナーゼインヒビター;ゲムシタビン;グルタチオンインヒビター;ヘプスルファム;ヘレグリン;ヘキサメチレンビサセタミド;ヒペリシン;イバンドロン酸;イダルビシン;イドキシフェン;イドラマントン;イルモフォシン;イロマスタット;イミダゾアクリドン;イミキモド;免疫賦活ペプチド;インスリン様増殖因子1受容体インヒビター;インターフェロンアゴニスト;インターフェロン;インターロイキン;イオベングアン;イオドドキソルビシン;イポメアノール、4−;イロプラクト;イルソグラジン;イソベンガゾール;イソホモハリコンドリンB;イタセトロン;ジャスプラキノリド;カハラリドF;ラメラリン−Nトリアセテート;ランレオチド;レイナマイシン;レノグラスチム;レンチナンスルフェート;レプトルスタチン;レトロゾール;白血病阻害因子;白血球アルファインターフェロン;リュープロリド+エストロゲン+プロゲステロン;リュープロレリン;レバミソール;リアロゾール;直鎖状ポリアミン類似体;親油性二糖ペプチド;親油性白金化合物;リソクリンアミド7;ロバプラチン;ロムブリシン;ロメトレクソール;ロニダミン;ロソクサントロン;ロバスタチン;ロクソリビン;ルートテカン;ルテチウムテクサフィリン;リソフィリン;溶解性ペプチド;マイタンシン;マンノスタチンA;マリマスタット;マソプロコール;マスピン;マトリライシンインヒビター;マトリックスメタロプロテアーゼインヒビター;メノガリル;メルバロン;メテレリン;メチオニナーゼ;メトクロプラミンド;MIFインヒビター;ミフェプリストン;ミルテホシン;ニリモスチム;ミスマッチ二重鎖RN
A;ミトグアゾン;ミトラクトール;マイトマイシン類似体;ミトナフィド;ミトトキシン線維芽細胞増殖因子−サポリン;ミトキサントロン;モファロテン;モルグラモスチム;モノクローナル抗体、ヒト絨毛性ゴナドトロピン;モノホスホリルリピドA+マイオバクテリウム細胞壁sk;モピダモール;多剤耐性遺伝子インヒビター;多発性腫瘍抑制因子1ベースの治療;マスタード抗がん剤;マイカペロキシドB;マイコバクテリアの細胞壁抽出物;マイリアポロン;N−アセチルジナリン;N−置換ベンズアミド;ナファレリン;ナグレスチップ;ナロキソン+ペンタゾシン;ナパビン;ナフテルピン;ナルトグラスチム;ネダプラチン;ネモルビシン;ネリドロン酸;中性エンドペプチダーゼ;ニルタミド;ニサマイシン;一酸化窒素調節因子;窒素酸化抗酸化物質;ニトルリン;O6−ベンジルグアニン;オクトレオチド;オキセノン;オリゴヌクレオチド;オナプリストン;オンダンセトロン;オンダンセトロン;オラシン;オーラルサイトカイン誘導体;オルマプラチン;オサテロン;オキサリプラチン;オクサウノマイシン;タキセル;タキセル類似体;タキセル誘導体;パラウアミン;パルミトイルリゾキシン;パミドロン酸;パナキシトリオール;パノミフェン;パラバクチン;パゼリプチン;ペガスパルガーゼ;ペルデシン;ペントサンポリ硫酸ナトリウム;ペントスタチン;ペントロゾール;ペルフルブロン;ペルフォスファミド;ペリリルアルコール;フェナジノマイシン;フェニルアセテート;ホスファターゼインヒビター;ピシバニル;ピロカルピンハイドロクロライド;ピラルビシン;ピリトレキシム;プラセチンA;プラセチンB;プラスミノーゲン活性化因子インヒビター;白金錯体;白金化合物;白金トリアミン錯体;ポルフィマーナトリウム;ポルフィロマイシン;プレドニゾン;プロピルビスアクリドン;プロスタグランジンJ2;プロテアソームインヒビター;プロテインAベースの免疫調節因子;プロテインキナーゼCインヒビター;プロテインキナーゼCインヒビター;微細藻類;タンパク質チロシンホスファターゼインヒビター;プリンヌクレオシドホスホリラーゼインヒビター;パープリン;ピラゾロアクリジン;ピリドキシル化ヘモグロビンポリオキシエチレン結合体;rafアンタゴニスト;ラルチトレキセド;ラモセトロン;rasファルネシルタンパク質転移酵素インヒビター;rasインヒビター;ras−GAPインヒビター;レテリプチン脱メチル化;レニウム(rheniuim)Re 186エチドロネート;リゾキシン;リボザイム;RIIレチンアミド;ログレチミド;ロヒツキン;ロムルチド;ロキニメックス; ルビギノンB1;ルボキシル;サフィンゴール;サイントピン;SarCNU;サルコフィトールA;サルグラモスチム;Sdi1ミメティクス;セムスチン;老化由来インヒビター1;センスオリゴヌクレオチド;シグナル伝達インヒビター;シグナル伝達調節因子;単鎖抗原結合タンパク質;シゾフィラン;ソブゾキサン;ナトリウムボロカプテート;ナトリウムフェニルアセテート;ソルベロール;ソマトメジン結合タンパク質;ソネルミン;スパルフォシン酸;スピカマイシンD;スピロムスチン;スプレノペンチン;スポンギスタチン1;スクアラミン;幹細胞インヒビター;幹細胞分裂インヒビター(ibitors);スチピアミド;ストロメライシンインヒビター;スルフィノシン;超活性血管作動性腸管ペプチドアンタゴニスト;スラジスタ;スラミン;スワインソニン;合成グリコサミノグリカン;タリムスチン;タモキシフェンメチオジド;タウロムスチン;タザロテン;テコガランナトリウム;テガフール;テルラピリリウム;テロメラーゼインヒビター;テモポルフィン;テモゾロミド;テニポシド;テトラクロロデカオキシド;テトラゾミン;タリブラスチン;チオコラリン;トロンボポエチン;トロンボポエチンミメティクス;サイマルファシン;サイモポエチン受容体アゴニスト;サイモトリナン;甲状腺刺激ホルモン;スズエチルエチオプルプリン;チラパザミン;チタノセンビクロリド;トプセンチン;トレミフェン;全能性幹細胞因子;翻訳インヒビター;トレチノイン;トリアセチルウリジン;トリシリビン;トリメトレキセート;トリプトレリン;トロピセトロン;ツロステリド;チロシンキナーゼ阻害薬;チロホスチン;UBCインヒビター;ウベニメクス;泌尿生殖器洞由来の増殖阻害因子;ウロキナーゼ受容体アンタゴニスト;バプレオチド;バリオリンB;ベクター系、赤血球遺伝子治療;ベラレソール;ベラミン;ベルジン;ベルテポルフィン;ビノレルビン;ビンクサルチン;ビタクシン;ボロゾール;ザノテロン;ゼニプラチン;ジラスコーブおよびジノスタチンスチマラマーが挙げられる。
VV皮膚乱切のマウスモデルを開発した。乱切したマウスで発生した急性表皮ポックス反応は、ヒト痘瘡ワクチンのものと非常に似ている。このモデルを用いて、皮膚乱切(s.s.)、皮下(s.c.)、皮膚内(i.d.)および筋肉内(i.m.)注射によるワクシニアウイルス(VV)免疫化の後に、一次およびメモリー適応免疫応答の厳密な比較を行った。高い免疫原性の腹腔内(i.p.)注射経路は、臨床での免疫化に使用しなかったが、VV特異的な免疫応答について正の対照として含めた。VV皮膚乱切は、従来の注射経路(s.c.、i.d.およびi.m.)と比較して、顕著により強い一次およびメモリーT細胞応答ならびにより高い血清VV特異的IgGレベルを誘導した(図1)。長期のT細胞メモリーおよび血清IgGレベルは、VV乱切したマウスおよびi.p.免疫化マウスにおいて同程度であった。したがって、皮膚乱切による限局性表皮VV免疫化は、IFN−γ応答および血清IgGレベルによれば、全身性ウイルス感染を確立するi.p.感染と比較して、同程度の免疫原性を達成する。
3つの異なるモデルを用いて、VV皮膚乱切により、二次チャレンジに対してより良い保護が提供できるかどうかを決定した。一次チャレンジモデルは、(皮膚感染による)皮膚性ポックスウイルス感染であった。このモデルは、2つの理由から選んだ。第1に、臨床的に、痘瘡ワクチン候補の保護効率は、Dryvax皮膚乱切によりワクチン接種した個人をチャレンジすることによって評価される。第2に、自然のポックスウイルス感染は、ウイルスへの皮膚性曝露によって、特に、損傷皮膚領域において、獲得することができる。皮膚チャレンジに続いて、皮膚でのウイルスの負荷を、VV特異的なリアルタイムPCRによって決定した(図2)。免疫化していない対照マウスと比較して、s.c.、i.d.およびi.m.注射によって免疫化したマウスは全て、ウイルスの負荷において15、9.5および3分の1への減少を伴う部分的な保護をそれぞれ実際に示した。ウイルスの負荷における3−logの減少が、i.p.免疫化マウスで達成された。著しいことに、皮膚乱切により事前に免疫化した全てのマウスは、この時点までにウイルスを完全に排除した。したがって、皮膚乱切は、高い免疫原性のi.p.経路を含む注射経路と比較して、二次皮膚性ポックスウイルスチャレンジに対して優れた保護を実現した。
ポックスウイルス皮膚乱切後の優れた保護効率の根底にある機構を調査するために、皮膚乱切関連免疫保護において、体液性および細胞性応答の関連の寄与を研究した。野生型(wt)およびB細胞欠乏型μMTマウスを、皮膚乱切またはi.p.注射、すなわちこの研究においてもっとも免疫原性の高い2つの経路によってVVで免疫化した。メモリーマウスを、次いで二次の皮膚性または鼻腔性ポックスウイルス感染によってチャレンジした。図5aに示すように、皮膚上にVVでチャレンジしたときに、i.p.免疫化μMTマウスは、免疫化したwtマウスより4−log高いウイルス負荷を有した。興味深いことに、s.s.経路により免疫化したμMTマウスでさえも、皮膚乱切により免疫化したwtマウスと同程度のウイルス負荷で、皮膚性チャレンジに対する強い保護を実際に示した。しかし、(抗CD4および抗CD8mAbを用いる多い用量の処置によって)チャレンジの前および最中に、T細胞をwtメモリーマウスから激減させたとき、免疫保護は、s.s.およびi.p.免疫化群の両方において完全に抑止された。このデータは、T細胞およびAbの両方が、i.p.免疫化の後の皮膚性チャレンジに対する保護に必要とされるが、VV皮膚乱切後のT細胞メモリー応答は、単独で皮膚性チャレンジを効果的に制御するほど強いことを示唆する。実際、チャレンジされた皮膚を排除する、脾臓およびリンパ節(LN)の両方における二次T細胞応答は、i.p.免疫化マウスより乱切した免疫マウスの方が顕著に強かった(図5b、c)。免疫化群の間の違いは、μMTマウスにおいてさらにより顕著であった。異なる群のマウス由来のチャレンジされた皮膚組織を、T細胞の存在について顕微鏡的にさらに調べた。著しいことに、大量のCD3+T細胞の浸潤が、s.s.経路により免疫化したマウスの基底の表皮および真皮において観察された一方、他の全ての免疫化群から収集した皮膚においては数個のT細胞のみが点在した(図5d)。総合して、これらのデータは、VV皮膚乱切が、二次皮膚性抗原チャレンジに対して高度に保護的である多数の皮膚ホーミングTemの発生において、比類なく強力であることを示唆する。
皮膚に制限した局所的VV感染後に、抗原特異的T細胞は、どのようにして高度に万能なホーミング能を発達させ、全身性免疫保護を提供するのだろうか。
前臨床および臨床試験の両方における、その印象的な安全性および免疫原性プロファイルのため、高度に弱毒化した複製欠陥のあるVV株MVAを、有望な生のウイルスワクチンベクターとして積極的に探索した。MVAワクチンを、注射経路によりもっぱら投与し、皮膚乱切は決して介さなかった。これは、表皮中でのウイルスの複製が、ポックス病変の発生およびチャレンジに対するその後の強い保護に必要であるという直観的な仮定に起因し得る。
Claims (14)
- 皮膚、肺、口腔粘膜、胃腸管、および生殖粘膜からなる群より選択される表皮組織において、ポックスウイルスに対して外来性のペプチドまたはポリペプチド抗原に対するT細胞記憶免疫応答を誘導または刺激するためのウイルス組成物であって、前記ウイルス組成物は、前記免疫応答を刺激するのに十分な量で前記抗原を発現する、生の非複製性ポックスウイルスからなり、前記ウイルス組成物は、被験体の機械的に破壊された表皮組織に投与されるものであり、前記ポックスウイルスは、正常な哺乳動物細胞に感染するが、非複製性である、組成物。
- 前記ポックスウイルスが、オルソポックス、スイポックス、カプリポックス、レポリポックス、パラポックスウイルス、伝染性軟属腫ウイルス、およびヤタポックスウイルスからなる群より選択される、請求項1に記載の組成物。
- 前記オルソポックスウイルスがワクシニアウイルスである、請求項2に記載の組成物。
- 前記ワクシニアウイルスが、改変ワクシニアウイルスAnkara(MVA)である、請求項3に記載の組成物。
- 前記上皮組織が、乱切針、皮下針、または擦過器により機械的に破壊された表皮である、請求項1に記載の組成物。
- 前記表皮が、前記組成物の投与と同時に、または投与前に、機械的に破壊される、請求項1に記載の組成物。
- 前記被験体が、がんを有するかまたはがんを発症する危険があり、前記抗原が、腫瘍関連抗原(TAA)、腫瘍特異抗原(TSA)、または組織特異抗原である、請求項1に記載の組成物。
- 前記がんが、皮膚、口腔粘膜、食道、生殖粘膜および泌尿生殖器粘膜に存在するか、またはこれらに由来する、請求項7に記載の組成物。
- 前記がんが、メラノーマ、扁平上皮癌、基底細胞癌、メルケル細胞癌、付属器癌、皮膚T細胞またはB細胞リンパ腫、肉腫、腺癌、前立腺腺癌、前立腺上皮新形成、肺扁平上皮癌、肺腺癌、小細胞肺癌、上皮由来の卵巣がん、結腸直腸腺癌および平滑筋肉種、胃腺癌および平滑筋肉腫、肝細胞癌、胆管癌、膵臓の管腺癌、膵内分泌部腫瘍、腎細胞癌、腎臓および膀胱の移行上皮癌、および膀胱扁平上皮癌からなる群より選択される、請求項8に記載の組成物。
- 前記被験体がウイルス感染、細菌感染、真菌感染、または原虫感染を有するかまたは発症する危険があり、前記抗原が、ウイルス抗原、細菌抗原、真菌抗原または原虫抗原である、請求項1に記載の組成物。
- 前記ウイルス感染が、HIV、インフルエンザ、デング熱、A型肝炎ウイルス、B型肝炎ウイルス、C型肝炎ウイルス、ヒトパピローマウイルス、エボラ、マールブルグ、狂犬病、ハンタウイルス感染、ウエストナイルウイルス、SARS様コロナウイルス、単純ヘルペスウイルス、水痘帯状疱疹ウイルス、エプスタインバーウイルス、ヒトヘルペスウイルス8型、アルファウイルス、およびセントルイス脳炎からなる群より選択され、
前記細菌感染が、Mycobacterium tuberculosis、Salmonella typhi、Bacillus anthracis、Yersinia
perstis、Francisella tularensis、Legionella、Chlamydia、Rickettsia typhi、およびTreponema pallidumからなる群より選択され、
前記真菌感染が、Coccidioides immitis、Blastomyces dermatitidis、Cryptococcus neoformans、Candida albicans、およびAspergillus種からなる群より選択され、
前記原虫感染が、Malaria(Plasmodium falciparum、Plasmodium vivax、Plasmodium ovale、Plasmodium malariae)、Leishmania種、Trypanosome種(アフリカおよびアメリカ)、クリプトスポリジウム、イソスポラ種、Naegleria fowleri、Acanthamoeba種、Balamuthia mandrillaris、Toxoplasma gondii、およびPneumocystis cariniiからなる群より選択される、請求項10に記載の組成物。 - 前記組成物の投与前、投与と同時、または投与後に、同じ部位で、または異なる部位で、共刺激分子、増殖因子、アジュバンドおよび/またはサイトカインと組み合わせて投与されるか、またはこれら共発現されるものであることを特徴とする、請求項1に記載の組成物。
- 前記共発現される共刺激分子が、IL−1、IL−2、IL−7、IL−12、IL−15、IL−18、IL−23、IL−27、B7−2、B7−H3、CD40、CD40L、ICOS−リガンド、OX−40L、4−1BBL、GM−CSF、SCF、FGF、Flt3−リガンド、CCR4からなる群より選択される、請求項12に記載の組成物。
- 被験体の上皮組織を機械的に破壊するためのデバイスと、
請求項1〜13のいずれか1項によって規定されるように破壊された上皮組織に投与された場合にT細胞記憶免疫応答を刺激するのに十分な量の抗原を発現する、生の非複製性ポックスウイルスからなるウイルス組成物と、
を含み、前記ポックスウイルスは、正常な哺乳動物細胞に感染するが、非複製性である、キット。
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KR20160103130A (ko) | 2013-12-30 | 2016-08-31 | 브이-코어 테크놀로지스 인코포레이티드 | 폭스바이러스-플라스모듐 재조합체, 이러한 재조합체를 함유하는 조성물, 이의 용도, 및 이의 제조 및 사용 방법 |
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