JP2013526617A5 - - Google Patents
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- JP2013526617A5 JP2013526617A5 JP2013512253A JP2013512253A JP2013526617A5 JP 2013526617 A5 JP2013526617 A5 JP 2013526617A5 JP 2013512253 A JP2013512253 A JP 2013512253A JP 2013512253 A JP2013512253 A JP 2013512253A JP 2013526617 A5 JP2013526617 A5 JP 2013526617A5
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- Prior art keywords
- surface antigens
- antigen
- virus
- protein
- composition
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Claims (20)
- 第1の組の表面抗原を含む第1の集合の合成ナノキャリアと、
第2の組の表面抗原を含む第2の集合の合成ナノキャリアと、
薬学的に許容可能な賦形剤と、
を含む剤形
を含む、組成物であって、
前記第1の組の表面抗原と前記第2の組の表面抗原とが構造的または免疫学的に異なる、組成物。 - 前記第1の組の表面抗原が、1、2、3、4、5、6、7、8、9、10またはそれより多くのタイプの抗原を含む、および/または、前記第2の組の表面抗原が、2、3、4、5、6、7、8、9、10またはそれより多くのタイプの抗原を含む、請求項1に記載の組成物。
- 前記第1の組の表面抗原が、第1の感染性の属、種もしくは株から得られるか、または誘導される抗原を含み、前記第2の組の表面抗原が、第2の感染性の属、種もしくは株から得られるか、または誘導される抗原を含み、任意に、前記第1の感染性の属、種もしくは株と前記第2の感染性の属、種もしくは株とが同一である、請求項1または2に記載の組成物。
- 前記第1の組の表面抗原および/または第2の組の表面抗原が、
(a)アデノウイルス科(Adenoviridae)、ピコルナウイルス科(Picornaviridae)、ヘルペスウイルス科(Herpesviridae)、ヘパドナウイルス科(Hepadnaviridae)、フラビウイルス科(Flaviviridae)、レトロウイルス科(Retroviridae)、オルトミクソウイルス科(Orthomyxoviridae)、パラミクソウイルス科(Paramyxoviridae)、パピローマウイルス科(Papillomaviridae)、ラブドウイルス科(Rhabdoviridae)、トガウイルス科(Togaviridae)またはパルボウイルス科(Paroviridae)のウイルス、任意に、アデノウイルス、コクサッキーウイルス、A型肝炎ウイルス、ポリオウイルス、ライノウイルス、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、ヒトサイトメガロウイルス、ヒトヘルペスウイルス、B型肝炎ウイルス、C型肝炎ウイルス、黄熱病ウイルス、デングウイルス、ウエストナイルウイルス、HIV、インフルエンザウイルス、麻疹ウイルス、流行性耳下腺炎ウイルス、パラインフルエンザウイルス、呼吸器多核体ウイルス、ヒトメタニューモウイルス、ヒトパピローマウイルス、狂犬病ウイルス、風疹ウイルス、ヒトボカウイルスまたはパルボウイルスB19、例えば、VI、VII、E1A、E3−19K、52K、VP1、表面抗原、3Aタンパク質、カプシドタンパク質、ヌクレオカプシド、表面突起、膜貫通タンパク質、UL6、UL18、UL35、UL38、UL19、初期抗原、カプシド抗原、Pp65、gB、p52、潜伏性核抗原−1、NS3、エンベロープタンパク質、エンベロープタンパク質E2ドメイン、gp120、p24、リポペプチドGag(17−35)、Gag(253−284)、Nef(66−97)、Nef(116−145)、Pol(325−355)、ノイラミニダーゼ、ヌクレオカプシドタンパク質、マトリックスタンパク質、リン酸化タンパク質、融合タンパク質、ヘマグルチニン、ヘマグルチニン−ノイラミニダーゼ、糖タンパク質、E6、E7、エンベロープのリポタンパク質または非構造タンパク質(NS);
(b)ボルデテラ属(Bordetella)、ボレリア属(Borrelia)、ブルセラ属(Brucella)、カンピロバクター属(Campylobacter)、クラミジア属(Chlamydia)およびクラミドフィラ属(Chlamydophila)、クロストリジウム属(Clostridium)、コリネバクテリウム属(Corynebacterium)、エンテロコッカス属(Enterococcus)、エシェリキア属(Escherichia)、フランシセラ属(Francisella)、ヘモフィルス属(Haemophilus)、ヘリコバクター属(Helicobacter)、レジオネラ属(Legionella)、レプトスピラ属(Leptospira)、リステリア属(Listeria)、マイコバクテリウム属(Mycobacterium)、マイコプラズマ属(Mycoplasma)、ナイセリア属(Neisseria)、シュードモナス属(Pseudomonas)、リケッチア属(Rickettsia)、サルモネラ属(Salmonella)、シゲラ属(Shigella)、スタフィロコッカス属(Staphylococcus)、ストレプトコッカス属(Streptococcus)、トレポネーマ属(Treponema)、ビブリオ属(Vibrio)またはエルシニア属(Yersinia)の細菌、任意に、ボルデテラ・パータシス(Bordetella pertussis)、ボレリア・ブルグドルフェリ(Borrelia burgdorferi)、ブルセラ・アボルタス(Brucella abortus)、ブルセラ・カニス(Brucella canis)、ブルセラ・メリテンシス(Brucella melitensis)、ブルセラ・スイス(Brucella suis)、カンピロバクター・ジェジュニ(Campylobacter jejuni)、クラミジア・ニューモニエ(Chlamydia pneumoniae)、クラミジア・トラコマチス(Chlamydia trachomatis)、クラミドフィラ・シタッシ(Chlamydophila psittaci)、クロストリジウム・ボツリヌム(Clostridium botulinum)、クロストリジウム・ディフィシル(Clostridium difficile)、クロストリジウム・パーフリンジェンス(Clostridium perfringens)、クロストリジウム・テタニ(Clostridium tetani)、コリネバクテリウム・ジフテリエ(Corynebacterium diphtheriae)、エンテロコッカス・フェカリス(Enterococcus faecalis)、エンテロコッカス・フェシウム(Enterococcus faecium)、エシェリキア・コリ(Escherichia coli)、フランシセラ・ツラレンシス(Francisella tularensis)、ヘモフィルス・インフルエンザエ(Haemophilus influenzae)、ヘリコバクター・ピロリ(Helicobacter pylori)、レジオネラ・ニューモフィラ(Legionella pneumophila)、レプトスピラ・インターロガンス(Leptospira interrogans)、リステリア・モノサイトゲネス(Listeria monocytogenes)、マイコバクテリウム・レプレ(Mycobacterium leprae)、マイコバクテリウム・ツベルクローシス(Mycobacterium tuberculosis)、マイコバクテリウム・ウルセランス(Mycobacterium ulcerans)、マイコプラズマ・ニューモニエ(Mycoplasma pneumoniae)、ナイセリア・ゴノレア(Neisseria gonorrhoeae)、ナイセリア・メニンギティディス(Neisseria meningitides)、シュードモナス・エルギノーサ(Pseudomonas aeruginosa)、リケッチア・リケッチ(Rickettsia rickettsii)、サルモネラ・チフィ(Salmonella typhi)、サルモネラ・チフィリウム(Salmonella typhimurium)、シゲラ・ソネイ(Shigella sonnei)、スタフィロコッカス・アウレウス(Staphylococcus aureus)、スタフィロコッカス・エピデルミデス(Staphylococcus epidermidis)、スタフィロコッカス・サプロフィチカス(Staphylococcus saprophyticus)、ストレプトコッカス・アガラクチア(Streptococcus agalactiae)、ストレプトコッカス・ニューモニエ(Streptococcus pneumonia)、ストレプトコッカス・ピオゲネス(Streptococcus pyogenes)、トレポネーマ・パリダム(Treponema pallidum)、ビブリオ・コレラエ(Vibrio cholerae)またはエルシニア・ペスチス(Yersinia pestis)、例えば、百日咳毒素(PT)、繊維状ヘマグルチニン(FHA)、パータクチン(PRN)、線毛(FIM 2/3)、VlsE;DbpA、OspA、Hia、PrpA、MltA、L7/L12、D15、0187、VirJ、Mdh、AfuA、L7/L12、外膜タンパク質、LPS、A抗原、B抗原、C抗原、D抗原、E抗原、FliC、FliD、Cwp84、アルファトキシン、シータトキシン、フルクトース1,6−二リン酸アルドラーゼ(FBA)、グリセルアルデヒド−3−リン酸脱水素酵素(GPD)、ピルビン酸フェレドキシン酸化還元酵素(PFOR)、伸長因子−G(EF−G)、機能が未知であるタンパク質(HP)、Tトキシン、トキソイド抗原、莢膜多糖、プロテインD、Mip、核タンパク質(NP)、RD1、PE35、PPE68、EsxA、EsxB、RD9、EsxV、Hsp70、リポ多糖、表面抗原、Sp1、Sp2、Sp3、グリセロホスホジエステルホスホジエステラーゼ、外膜タンパク質、シャペロン・アッシャータンパク質、莢膜タンパク質(F1)またはVタンパク質;および/または
(c)カンジダ属(Candida)、アスペルギルス属(Aspergillus)、クリプトコッカス属(Cryptococcus)、ヒストプラズマ属(Histoplasma)、ニューモシスチス属(Pneumocystis)またはスタキボトリス属(Stachybotrys)の真菌、任意に、カンジダ・アルビカンス(C. albicans)、アスペルギルス・フミガーツス(Aspergillus fumigatus)、アスペルギルス・フラバス(Aspergillus flavus)、クリプトコッカス・ネオフォルマンス(Cryptococcus neoformans)、クリプトコッカス・ラウレンチイ(Cryptococcus laurentii)、クリプトコッカス・アルビダス(Cryptococcus albidus)、クリプトコッカス・ガッティ(Cryptococcus gattii)、ヒストプラズマ・カプスラーツム(Histoplasma capsulatum)、ニューモシスチス・ジロベシ(Pneumocystis jirovecii)またはスタキボトリス・チャータラム(Stachybotrys chartarum)、例えば、表面抗原、莢膜糖タンパク質、Yps3P、Hsp60、主要表面タンパク質、MsgC1、MsgC3、MsgC8、MsgC9またはSchS34
から得られるか、または誘導される抗原を含む、請求項1〜3のいずれか一項に記載の組成物。 - 1種類以上のアジュバントをさらに含み、任意に、前記第1の集合の合成ナノキャリアおよび/または前記第2の集合の合成ナノキャリアが、前記合成ナノキャリアに結合されたアジュバントをさらに含む、請求項1〜4のいずれか一項に記載の組成物。
- (a)前記アジュバント同士が異なっている;
(b)前記第1の集合の合成ナノキャリアに結合されたアジュバントおよび/または前記第2の集合の合成ナノキャリアに結合されたアジュバントが、TLR−2アゴニスト、TLR−3アゴニスト、TLR−4アゴニスト、TLR−7アゴニスト、TLR−8アゴニストまたはTLR−9アゴニストを含む;
(c)前記第1の集合の合成ナノキャリアに結合された前記アジュバントおよび/または前記第2の集合の合成ナノキャリアに結合された前記アジュバントが、免疫刺激性核酸、イミダゾキノリン、オキソアデニン、MPL、イミキモドまたはレシキモドを含む;
(d)前記組成物が、1種類以上の混合アジュバントを含み、任意に前記混合アジュバントが、CpG、AS01、AS02、AS04、AS15、QS−21、サポニン、ミョウバンまたはMPLを含む免疫刺激性核酸である;および/または
(e)前記1種類以上のアジュバントが各々、鉱物塩、ミョウバン、腸内細菌のモノホスホリルリピド(MPL)Aと組み合わせたミョウバン、MPL(登録商標)(AS04)、AS15、サポニン、QS−21、Quil−A、ISCOMs、ISCOMATRIX(商標)、MF59(商標)、Montanide(登録商標) ISA 51、Montanide(登録商標) ISA 720、AS02、リポソームまたはリポソーム製剤、AS01、AS15、合成または特異的に調製した微粒子およびマイクロキャリア、ナイセリア・ゴノレー(N. gonorrheae)またはクラミジア・トラコマチス(Chlamydia trachomatis)の細菌由来の外膜小胞、キトサン粒子、デポを形成する作用剤、Pluronic(登録商標)ブロックコポリマー、特異的に修飾または調製されたペプチド、ムラミルジペプチド、アミノアルキルグルコサミニド4−ホスフェート、RC529、細菌トキソイド、毒素フラグメント、Toll様受容体2、3、4、5、7、8または9のアゴニスト、アデニン誘導体、免疫刺激性DNA、免疫刺激性RNA、イミダゾキノリンアミン、イミダゾピリジンアミン、6,7−縮合シクロアルキルイミダゾピリジンアミン、1,2−架橋イミダゾキノリンアミン、イミキモド、レシキモド、DC表面分子CD40のアゴニスト、I型インターフェロン、poly I:C、細菌のリポ多糖(LPS)、VSV−G、HMGB−1、フラジェリンまたはその一部または誘導体、CpGを含む免疫刺激性DNA分子、ネクローシス細胞から放出される炎症誘発性刺激物質、尿酸結晶、補体カスケードの活性成分、免疫複合体の活性成分、補体受容体アゴニスト、サイトカインまたはサイトカイン受容体アゴニストを含む、
請求項5に記載の組成物。 - 前記第1および第2の集合の合成ナノキャリアが、被検体において前記第1の組の表面抗原および前記第2の組の表面抗原に対する免疫反応を生じさせるのに有効な量で存在し、任意に、前記免疫反応が、前記第1の組の表面抗原および前記第2の組の表面抗原に特異的な抗体価を生じさせることである、請求項1〜6のいずれか一項に記載の組成物。
- 1種類以上の別の集合の合成ナノキャリアをさらに含み、別の集合の合成ナノキャリアが各々、前記組成物中の他の複数組の表面抗原とは構造的に異なる一組の表面抗原を含み、任意に、前記1種類以上の別の集合の合成ナノキャリアの少なくとも1つが、これに結合したアジュバントをさらに含み、例えば、前記1種類以上の別の集合の合成ナノキャリアの前記少なくとも1つに結合した前記アジュバントが、前記組成物中の他のアジュバントとは異なる、請求項1〜7のいずれか一項に記載の組成物。
- 各組の表面抗原が、一価または多価(oligovalent)の組の表面抗原である、請求項1〜8のいずれか一項に記載の組成物。
- 前記複数集合の合成ナノキャリアが、各組の表面抗原に対する免疫反応を生じさせるのに有効な量で存在し、前記免疫反応が、任意に各組の表面抗原に特異的な抗体価を生じさせることである、請求項8または9に記載の組成物。
- 前記第1および/または第2の集合の合成ナノキャリアが、任意にカプセル化によって、これに結合した普遍的T細胞抗原をさらに含み、前記普遍的T細胞抗原が、任意に、ヘルパーT細胞抗原、例えばオボアルブミンから得られるまたは誘導されるペプチドを含むヘルパーT細胞抗原を含み、例えば、オボアルブミンから得られるまたは誘導される前記ペプチドが、配列番号1に示す配列を含む、請求項1〜10のいずれか一項に記載の組成物。
- 前記第1の組の表面抗原および第2の組の表面抗原が、構造的または免疫学的に異なり、乱用物質または嗜癖性物質から得られるか、または誘導される抗原を含み、任意に、前記乱用物質または嗜癖性物質がコカインまたはニコチンである、請求項1または2に記載の組成物。
- (a)前記第1の組の表面抗原および前記第2の組の表面抗原が同一の表面抗原を含み、前記第1の組の表面抗原のうちの少なくとも1種類の抗原が、前記第2の組の表面抗原で提示されるものとは異なる向きで提示される;
(b)前記第1の組の表面抗原および前記第2の組の表面抗原が同一の表面抗原を含み、前記第1の組の表面抗原のうちの少なくとも1種類の抗原が、前記第2の組の表面抗原で提示されるものとは異なるコンホメーションで提示される;または
(c)前記第1の組の表面抗原と前記第2の組の表面抗原の分子構造が異なる、
請求項1〜12のいずれか一項に記載の組成物。 - (a)前記第1の組の表面抗原が、ペプチド、タンパク質、オリゴ糖、多糖および/または小分子を含む表面抗原を含む;
(b)前記第2の組の表面抗原が、ペプチド、タンパク質、オリゴ糖、多糖および/または小分子を含む表面抗原を含む;および/または
(c)前記第1の組の表面抗原および/または前記第2の組の表面抗原が、分子量10,000Da未満の表面抗原を含む、請求項1〜13のいずれか一項に記載の組成物。 - 前記薬学的に許容可能な賦形剤が、保存剤、緩衝液、生理食塩水、リン酸緩衝生理食塩水、着色剤または安定剤を含む、請求項1〜14のいずれか一項に記載の組成物。
- 前記複数集合の合成ナノキャリア各々の合成ナノキャリアが、脂質ベースのナノ粒子、ポリマーナノ粒子、金属ナノ粒子、界面活性剤ベースのエマルション、デンドリマー、バッキーボール、ナノワイヤ、ウイルス様粒子、ペプチドまたはタンパク質ベースの粒子、脂質−ポリマーナノ粒子、回転楕円形のナノ粒子、直方体形のナノ粒子、角錐形のナノ粒子、長円形のナノ粒子、円柱形のナノ粒子またはドーナツ形のナノ粒子を含む、請求項1〜15のいずれか一項に記載の組成物。
- 前記複数集合の合成ナノキャリアの各々が、1種類以上のポリマーを含み、(a)前記1種類以上のポリマーが、ポリエステルを含む;ならびに/あるいは(b)前記1種類以上のポリマーが、親水性ポリマーに結合されたポリエステルを含むか、またはさらに含み、例えば、前記ポリエステルが、ポリ(乳酸)、ポリ(グリコール酸)、ポリ(乳酸−co−グリコール酸)もしくはポリカプロラクトンを含み、および/または、前記親水性ポリマーがポリエーテル(例えばポリエチレングリコール)を含む、請求項16に記載の組成物。
- 第1の組の表面抗原を提示するための第1の合成ナノキャリア手段と、
第2の組の表面抗原を提示するための第2の合成ナノキャリア手段と、
薬学的に許容可能な賦形剤と、
を含む剤形
を含む、組成物であって、
前記第1の組の表面抗原と前記第2の組の表面抗原とが構造的または免疫学的に異なり、任意に、前記第1の組の表面抗原が第1の組の一価表面抗原または多価(oligovalent)表面抗原を含む;および、前記第2の組の表面抗原が第2の組の一価表面抗原または多価(oligovalent)表面抗原を含む、前記組成物。 - 治療または予防に用いられるための、例えば(a)感染症もしくは感染性の疾患を治療もしくは予防する方法;(b)がんを治療もしくは予防する方法;(c)嗜癖を治療もしくは予防する方法;および/または(d)経口、皮下、経肺、鼻腔内、皮内または筋肉内投与による前記組成物の投与を含む方法に用いられるための、請求項1〜18のいずれか一項に記載の組成物。
- 組成物の剤形を製造するためのプロセスであって、該プロセスが、
第1の組の表面抗原を含む第1の集合の合成ナノキャリアを調製すること;
第2の組の表面抗原を含む第2の集合の合成ナノキャリアを調製すること;および
前記第1の集合の合成ナノキャリアと第2の集合の合成ナノキャリアとを組み合わせて剤形にすることを含み、
前記第1の組の表面抗原と前記第2の組の表面抗原とが構造的または免疫学的に異なり、任意に、
(a)各組の表面抗原に対する免疫反応が生じるか否か、例えば前記免疫反応が前記各組の表面抗原に特異的な抗体価を生じさせることである;および/または
(b)各組の表面抗原に対する前記免疫反応を生じさせるのに有効な量
を判断するステップをさらに含む、前記プロセス。
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