JP2018532813A - 体液性親和性の加速に関する方法及び組成物 - Google Patents
体液性親和性の加速に関する方法及び組成物 Download PDFInfo
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Abstract
Description
アジュバントの機能に応じて、アジュバントは2つの群に分類され得る。第1の群に属するアジュバントは、抗原を吸着し、抗原が細胞により貧食されるのを助けるために使用され、これにはアルミニウム塩及びM59乳化剤などが挙げられる(O’Hagan D T,Wack A,Podda A.Clin Pharmacol Ther.2007 December;82(6):740〜4;4.Clapp T,Siebert P,Chen D,Jones Braun L.J Pharm Sci.2011 February;100(2):388〜401)。第2の群に属するアジュバントは、免疫調節因子であり、これにはCFAマイコバクテリアなどが挙げられる(Hoft D F,Blazevic A,Abate G,Hanekom W A,Kaplan G,Soler J H,Weichold F,Geiter L,Sadoff J C,Horwitz M A.J Infect Dis.2008 Nov.15;198(10):1491〜501)。親和性成熟を含む体液性免疫を加速させる新しいワクチンアジュバントは、当該技術分野で有用である。
更に開示されるのは、抗原と、クラミジア種のタンパク質、ペプチド、若しくは炭水化物、又はそれらの断片と、を含むキットである。
「a」及び「an」という冠詞は、冠詞の文法上の目的語の1つ、又は1つを超える(即ち、少なくとも1つ)を指すために使用される。例として、「an element」は、1つの要素又は1つを超える要素を意味する。
同種抗原及びクラミジアの同時インビボ投与は、強力な抗原特異的体液性免疫の発生を誘導し、より親和性の高い抗原特異的抗体の発生を加速させることが発見されている。例えば、本明細書に開示されるのは、HIV−1特異的中和抗体の形成である。
マウスオボアルブミン(OVA)及び不活性化C.トラコマチス基本小体(EB)を、2週間毎に1ヶ月間投与した(即ち、計3回の処置)。この研究において、これらのマウスは、OVAのみを投与されたマウスと比較して、著しく高いOVA特異的IgM及びIgG血清抗体濃度を示し(図1)、OVA特異的抗体の親和性は、OVA及びクラミジアEBで同時に処置されたマウスにおいて著しく高かった(図2)。後者の結果は、EBの使用がOVA特異的抗体の親和性成熟の過程を加速したことを示した。これらの結果と同様に、ジフテリア毒素(DT)及びクラミジアEBの単一用量を投与したマウスは、DT特異的IgG抗体の著しく高い血清濃度を生じた(図3)。更に、これらのマウスは、DTのみで処置されたマウスと比較して、致死的DT攻撃に対する感受性が低下した(図4)。
初期実験プラットフォームとしてマウスを使用したインビボ研究を実施することができる。クラミジアがC57BL/6マウスにおいてEnvの免疫原性を高め得るかどうかについて、ELISA及びB細胞のELISPOT測定により抗原特異的応答の大きさを決定することにより判定する。次に、Env特異的抗体応答の親和性を、カオトロピックELISAプロトコールの使用により定義する。その後、単一Env特異的記憶B細胞及び胚中心B細胞を同定して免疫化C57BL/6マウスから単離し、クラミジアが体細胞突然変異の程度を高め得るかどうかを判定する。また、十分に標準化したEnv偽ウイルスアッセイ及びTZM−bl標的細胞を使用して、Env特異的抗体を生じさせる能力を高めてHIV−1を中和するためのアジュバントとしてクラミジアを評価する。最後に、他の種類のアジュバント、例えば、無機塩(例えば、ミョウバン)、油エマルション(例えば、MF59)、及び微粒子(例えば、AbISCO−100)と同時に使用する場合、B細胞アジュバントとして作用してEnv特異的抗体の濃度及び親和性を高めるクラミジアの能力を評価することができる。
Claims (38)
- 抗原と、クラミジア種のタンパク質、ペプチド、若しくは炭水化物、又はそれらの断片と、を含むワクチンであって、前記抗原がクラミジア種に由来しない、ワクチン。
- 前記クラミジア種が、C.トラコマチス、C.シッタシ、C.ムリダルム、又はC.ニューモニエを含む、請求項1に記載のワクチン。
- 前記クラミジア種が、不活性化される、請求項1又は2に記載のワクチン。
- 前記クラミジア種のタンパク質、ペプチド、若しくは炭水化物、又はそれらの断片が、クラミジアの主要外膜(MOMP)タンパク質を含む、請求項1〜3のいずれか一項に記載のワクチン。
- 前記ワクチンが、2つ以上の抗原を含む、請求項1〜4のいずれか一項に記載のワクチン。
- 前記ワクチンが、3つ以上の抗原を含む、請求項5に記載のワクチン。
- 前記抗原が、感染因子を含む、請求項1〜6のいずれか一項に記載のワクチン。
- 前記感染因子が、ウイルス性である、請求項7に記載のワクチン。
- 前記ウイルス性感染因子が、HIVである、請求項8に記載のワクチン。
- 前記抗原が、腫瘍関連抗原を含む、請求項1〜6のいずれか一項に記載のワクチン。
- 前記ワクチンが、前記抗原単独と比較して、特異的体液性免疫を高める、請求項1〜10のいずれか一項に記載のワクチン。
- 抗原と、クラミジア種のタンパク質、ペプチド、若しくは炭水化物、又はそれらの断片と、を含むキットであって、前記抗原がクラミジア種に由来しない、キット。
- 対象における疾患又は感染を予防する方法であって、前記方法が、前記対象に抗原を投与することを含み、前記抗原が、クラミジア種;及びクラミジア種のタンパク質、ペプチド、若しくは炭水化物、又はそれらの断片に由来せず、それによって前記対象における疾患又は感染を予防する、方法。
- 前記クラミジア種が、C.トラコマチス、C.シッタシ、C.ムリダルム、又はC.ニューモニエを含む、請求項13に記載の方法。
- 前記クラミジア種が、不活性化される、請求項13〜14のいずれか一項に記載の方法。
- 前記クラミジア種のタンパク質が、主要外膜(MOMP)タンパク質を含む、請求項13〜15のいずれか一項に記載の方法。
- 前記抗原が、ウイルス性である、請求項13〜16のいずれか一項に記載の方法。
- 前記抗原が、HIVに由来する、請求項17に記載の方法。
- 前記抗原が、envタンパク質、ペプチド、又はそれらの断片である、請求項18に記載の方法。
- 前記抗原が、腫瘍関連である、請求項13〜19のいずれか一項に記載の方法。
- 前記対象が、哺乳類である、請求項13〜20のいずれか一項に記載の方法。
- 前記哺乳類が、ヒトである、請求項21に記載の方法。
- 前記抗原と、前記クラミジア種のタンパク質、ペプチド、若しくは炭水化物、又はそれらの断片、又はそれらの断片とが、同時に投与される、請求項13〜22のいずれか一項に記載の方法。
- 前記抗原が、前記クラミジア種のタンパク質、ペプチド、若しくは炭水化物、又はそれらの断片の前に投与される、請求項13〜22のいずれか一項に記載の方法。
- 前記抗原が、前記クラミジア種のタンパク質、ペプチド、若しくは炭水化物、又はそれらの断片の後に投与される、請求項13〜22のいずれか一項に記載の方法。
- 治療を必要としている対象を治療する方法であって、前記方法が、前記対象に抗原を投与することを含み、前記抗原が、クラミジア種;及びクラミジア種由来のタンパク質、ペプチド、又は断片に由来せず、それによって前記対象を治療する、方法。
- 前記クラミジア種が、C.トラコマチス、C.シッタシ、又はC.ムリダルムを含む、請求項26に記載の方法。
- 前記クラミジア種が、不活性化される、請求項26〜27のいずれか一項に記載の方法。
- 前記クラミジア種のタンパク質が、主要外膜(MOMP)タンパク質を含む、請求項26〜28のいずれか一項に記載の方法。
- 前記抗原が、ウイルス性である、請求項26〜29のいずれか一項に記載の方法。
- 前記抗原が、HIVに由来する、請求項30に記載の方法。
- 前記抗原が、envタンパク質、ペプチド、又はそれらの断片である、請求項31に記載の方法。
- 前記抗原が、腫瘍関連である、請求項26〜32のいずれか一項に記載の方法。
- 前記対象が、哺乳類である、請求項26〜33のいずれか一項に記載の方法。
- 前記哺乳類が、ヒトである、請求項34に記載の方法。
- 前記抗原と、前記クラミジア種のタンパク質、ペプチド、若しくは炭水化物、又はそれらの断片とが、同時に投与される、請求項26〜35のいずれか一項に記載の方法。
- 前記抗原が、前記クラミジア種のタンパク質、ペプチド、若しくは炭水化物、又はそれらの断片の前に投与される、請求項26〜35のいずれか一項に記載の方法。
- 前記抗原が、前記クラミジア種のタンパク質、ペプチド、若しくは炭水化物、又はそれらの断片の後に投与される、請求項26〜35のいずれか一項に記載の方法。
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