JP2021191783A - 新生児及び乳幼児におけるワクチン接種 - Google Patents
新生児及び乳幼児におけるワクチン接種 Download PDFInfo
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Abstract
Description
CA125、カルレティキュリン、CAMEL、CASP−8/m、カテプシンB、カテプシンL、CD19、CD20、CD22、CD25、CDE30、CD33、CD40、CD52、CD55、CD56、CD80、CDC27/m、CDK4/m、CDKN2A/m、CEA、CLCA2、CML28、CML66、COA−1/m、コアクトシン様タンパク質、コラーゲンXXIII、COX−2、CT−9/BRD6、Cten、サイクリンB1、サイクリンD1、cyp−B、CYPB1、DAM−10、DAM−6、DEK−CAN、EFTUD2/m、EGFR、ELF2/m、EMMPRIN、EpCam、EphA2、EphA3、ErbB3、ETV6−AML1、EZH2、FGF−5、FN、Frau−1、G250、GAGE−1、GAGE−2、GAGE−3、GAGE−4、GAGE−5、GAGE−6、GAGE7b、GAGE−8、GDEP、GnT−V、gp100、GPC3、GPNMB/m、HAGE、HAST−2、ヘプシン、Her2/neu、HERV−K−MEL、HLA−A*0201−R17I、HLA−A11/m、HLA−A2/m、HNE、ホメオボックスNKX3.1、HOM−TES−14/SCP−1、HOM−TES−85、HPV−E6、HPV−E7、HSP70−2M、HST−2、hTERT、iCE、IGF−1R、IL−13Ra2、IL−2R、IL−5、未熟ラミニン受容体、カリクレイン−2、カリクレイン−4、Ki67、KIAA0205、KIAA0205/m、KK−LC−1、K−Ras/m、LAGE−A1、LDLR−FUT、MAGE−A1、MAGE−A2、MAGE−A3、MAGE−A4、MAGE−A6、MAGE−A9、MAGE−A10、MAGE−A12、MAGE−B1、MAGE−B2、MAGE−B3、MAGE−B4、MAGE−B5、MAGE−B6、MAGE−B10、MAGE−B16、MAGE−B17、MAGE−C1、MAGE−C2、MAGE−C3、MAGE−D1、MAGE−D2、MAGE−D4、MAGE−E1、MAGE−E2、MAGE−F1、MAGE−H1、MAGEL2、マンマグロビンA、MART−1/メラン−A、MART−2、MART−2/m、基質タンパク質22、MC1R、M−CSF、ME1/m、メソテリン、MG50/PXDN、MMP11、MN/CA IX−抗原、MRP−3、MUC−1、MUC−2、MUM−1/m、MUM−2/m、MUM−3/m、ミオシンクラスI/m、NA88−A、N−アセチルグルコサミニルトランスフェラーゼ−V、Neo−PAP、Neo−PAP/m、NFYC/m、NGEP、NMP22、NPM/ALK、N−Ras/m、NSE、NY−ESO−1、NY−ESO−B、OA1、OFA−iLRP、OGT、OGT/m、OS−9、OS−9/m、オステオカルシン、オステオポンチン、p15、p190マイナーbcr−abl、p53、p53/m、PAGE−4、PAI−1、PAI−2、PART−1、PATE、PDEF、Pim−1−キナーゼ、Pin−1、Pml/PARα、POTE、PRAME、PRDX5/m、プロステイン、プロテイナーゼ−3、PSA、PSCA、PSGR、PSM、PSMA、PTPRK/m、RAGE−1、RBAF600/m、RHAMM/CD168、RU1、RU2、S−100、SAGE、SART−1、SART−2、SART−3、SCC、SIRT2/m、Sp17、SSX−1、SSX−2/HOM−MEL−40、SSX−4、STAMP−1、STEAP、サバイビン、サバイビン−2B、SYT−SSX−1、SYT−SSX−2、TA−90、TAG−72、TARP、TEL−AML1、TGFβ、TGFβRII、TGM−4、TPI/m、TRAG−3、TRG、TRP−1、TRP−2/6b、TRP/INT2、TRP−p8、チロシナーゼ、UPA、VEGF、VEGFR−2/FLK−1、及びWT1からなる群から選択される。
(Arg)l;(Lys)m;(His)n;(Orn)o;(Xaa)x
ここで、l+m+n+o+x=8〜15であり、l、m、n又はoは、互いに独立して、0、1、2、3、4、5、6、7、8、9、10、11、12、13、14又は15から選択される任意の数であり(但し、Arg、Lys、His及びOrnがオリゴペプチドの全アミノ酸の少なくとも50%を表す)、Xaaは、Arg、Lys、His又はOrnを除くネイティブの(=天然に存在する)又は非ネイティブのアミノ酸から選択される任意のアミノ酸であってもよく、xは、0、1、2、3又は4から選択される任意の数であってもよい(但し、Xaaの総含有量がオリゴペプチドの全アミノ酸の50%を超えない)。
これに関連して特に好ましいカチオン性ペプチドは、例えば、Arg7、Arg8、Arg9、H3R9、R9H3、H3R9H3、YSSR9SSY、(RKH)4、及びY(RKH)2R等である。トランスフェクション剤として使用することができる更に好ましいカチオン性又はポリカチオン性の化合物としては、例えばキトサン及びポリブレン等のカチオン性多糖類、例えばポリエチレンイミン(PEI)等のカチオン性ポリマー、例えばDOTMA([1−(2,3−ジオレイルオキシ)プロピル)]−N,N,N−トリメチルアンモニウムクロリド)、DMRIE、ジC14−アミジン、DOTIM、SAINT、DC−Chol、BGTC、CTAP、DOPC、DODAP、DOPE(ジオレイルホスファチジルエタノールアミン)、DOSPA、DODAB、DOIC、DMEPC、DOGS(ジオクタデシルアミドグリシルスペルミン)、DIMRI(Dジミリスト−オキシプロピルジメチルヒドロキシエチルアンモニウムブロマイド)、DOTAP(ジオレオイルオキシ−3−(トリメチルアンモニオ)プロパン、DC−6−14(O,O−ジテトラデカノイル−N−(α−トリメチルアンモニオアセチル)ジエタノールアミンクロリド)、CLIP1(RAC−[(2,3−ジオクタデシルオキシプロピル)(2−ヒドロキシエチル)]−ジメチルアンモニウムクロリド)、CLIP6(rac−[2(2,3−ジヘキサデシルオキシプロピル−オキシメチルオキシ)エチル]トリメチルアンモニウム)、CLIP9(rac−[2(2,3−ジヘキサデシルオキシプロピル−オキシスクシニルオキシ)エチル]−トリメチルアンモニウム及びオリゴフェクタミン等のカチオン性脂質、或いは、例えば、β−アミノ酸ポリマー又は逆向きポリアミド等の修飾ポリアミノ酸、PVP(ポリ(N−エチル−4−ビニルピリジニウムブロミド))等の修飾ポリエチレン、pDMAEMA(ポリ(ジメチルアミノエチルメチルアクリレート))等の修飾アクリレート、pAMAM(ポリ(アミドアミン))等の修飾アミドアミン、ジアミン末端修飾1,4−ブタンジオールジアクリレート−co−5−アミノ−1−ペンタノールポリマー等の修飾ポリβ−アミノエステル(PBAE)、ポリプロピルアミンデンドリマー又はpAMAM系デンドリマー等のデンドリマー、PEI(ポリ(エチレンイミン))及びポリ(プロピレンイミン)等のポリイミン、ポリアリルアミン、シクロデキストリン系ポリマー、デキストラン系ポリマー及びキトサン等の糖骨格系ポリマー、PMOXA−PDMS共重合体等のシラン骨格系ポリマー、1以上のカチオン性ブロック(例えば、上述のカチオン性ポリマーから選択される)の組合せからなるブロックポリマー、及び1以上の親水性ブロック又は疎水性ブロック(例えば、ポリエチレングリコール)の組合せからなるブロックポリマー等のカチオン性又はポリカチオン性のポリマー等が挙げられ得る。
CysArg8Cys Cys−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Cys (配列番号:2)
CysArg9Cys: Cys−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Cys (配列番号:3)
CysArg10Cys Cys−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Cys (配列番号:4)
CysArg11Cys Cys−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Cys (配列番号:5)
CysArg12Cys: Cys−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Cys (配列番号:6)
CysArg13Cys: Cys−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Cys (配列番号:7)
CysArg14Cys: Cys−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Cys (配列番号:8)
CysArg15Cys: Cys−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Cys (配列番号:9)
CysArg16Cys: Cys−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Cys (配列番号:10)
CysArg17Cys: Cys−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Cys (配列番号:11)
CysArg18Cys: Cys−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Cys (配列番号:12)
CysArg19Cys: Cys−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Cys (配列番号:13)
CysArg20Cys: Cys−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg−Arg Cys (配列番号:14)
ここで、P1及びP3は、互いに異なるか又は同一であり、直鎖状又は分枝状の親水性ポリマー鎖を表し、各々のP1及びP3は、成分P2との縮合により、或いは、(AA)、(AA)x又は[(AA)x]z(そのような成分がP1及びP2又はP3及びP2の間のリンカーとして使用される場合)、及び更なる成分(例えば、(AA)、(AA)x、[(AA)x]z又はL)の少なくともいずれかとの縮合によりジスルフィド結合を形成可能な、少なくとも1つの−SH部分を提示し、前記直鎖状又は分枝状の親水性ポリマー鎖は、互いに独立して、ポリエチレングリコール(PEG)、ポリ−N−(2−ヒドロキシプロピル)メタクリルアミド、ポリ−2−(メタクリロイルオキシ)エチルホスホリルコリン、ポリ(ヒドロキシアルキルL−アスパラギン)、ポリ(2−(メタクリロイルオキシ)エチルホスホリルコリン)、ヒドロキシエチルデンプン、又はポリ(ヒドロキシアルキルL−グルタミン)から選択され、ここで、前記親水性ポリマー鎖は、約1kDa〜約100kDa、好ましくは約2kDa〜約25kDa、より好ましくは約2kDa〜約10kDa、例えば約5kDa〜約25kDa又は5kDa〜約10kDaの分子量を示し、
P2は、例えば本明細書で定義するカチオン性又はポリカチオン性のペプチド又はタンパク質、であり、好ましくは約3〜100アミノ酸長を有し、より好ましくは約3〜約50アミノ酸長を有し、更により好ましくは約3〜約25アミノ酸長、例えば約3〜10アミノ酸長、5〜15アミノ酸長、10〜20アミノ酸長又は15〜25アミノ酸長、より好ましくは約5〜20アミノ酸長、及び更により好ましくは約10〜約20アミノ酸長を有するか、又は、
P2は、典型的には、約1kDa〜約20kDa、更に好ましくは約1.5kDa〜約10kDaの分子量を含む約0.5kDa〜約30kDaの分子量を有するか、又は、約10kDa〜約50kDa、更に好ましくは約10kDa〜約30kDaの分子量を含む約0.5kDa〜約100kDaの分子量を有する、例えば本明細書で定義するカチオン性又はポリカチオン性のポリマーであり、各P2は、更なる成分P2、又は成分P1及び成分P3の少なくともいずれかと、或いは代替的に更なる成分(例えば、(AA)、(AA)x、又は[(AA)x]z)との縮合によりジスルフィド結合を形成可能な少なくとも2つの−SH部分を提示し、
−S−S−は、(可逆の)ジスルフィド結合(読み易くするために括弧は省略されている)であり、ここで、Sは、好ましくは、硫黄、又は(可逆の)ジスルフィド結合を形成した−SH担持部分を表す。前記(可逆の)ジスルフィド結合は、好ましくは、成分P1及びP2、P2及びP2、又はP2及びP3、或いは任意的に本明細書で定義する更なる成分(例えば、L、(AA)、(AA)x、[(AA)x]z等)のいずれかの−SH部分の縮合により形成され、前記−SH部分は、これらの成分の構造の一部であるか、又は以下で定義する修飾によって付加されてもよく、
Lは、存在してもしなくてもよい任意的なリガンドであり、互いに独立して、RGD、トランスフェリン、葉酸、シグナルペプチド又はシグナル配列、局在化シグナル又は局在化配列、核酸局在化シグナル又は核酸局在化配列(NLS)、抗体、細胞透過性ペプチド(例えば、TAT、又はKALA)、受容体のリガンド(例えば、サイトカイン、ホルモン、成長因子等)、小分子(例えば、マンノース、ガラクトース、又は合成リガンド等の炭水化物)、小分子アゴニスト、受容体の阻害剤又はアンタゴニスト(例えば、RGDペプチド模倣薬類似体)等から選択され、
nは、典型的には、例えば、約4〜9、4〜10、3〜20、4〜20、5〜20又は10〜20の範囲、約3〜15、4〜15又は10〜15の範囲、或いは約6〜11又は7〜10の範囲をを含む、約1〜50の範囲、好ましくは約1、2又は3〜30の範囲、より好ましくは約1、2、3、4又は5〜25の範囲、約1、2、3、4又は5〜20の範囲、約1、2、3、4又は5〜15の範囲、又は約1、2、3、4又は5〜10の範囲から選択される整数である。最も好ましくは、nは、約1、2、3、4又は5〜10の範囲、より好ましくは約1、2、3又は4〜9の範囲、約1、2、3又は4〜8の範囲、又は約1、2又は3〜7の範囲である。
ここで、Gは、グアノシン、ウラシル、又はグアノシンの類似体若しくはウラシルの類似体であり、Xは、グアノシン、ウラシル、アデノシン、チミジン、シトシン、又は上記ヌクレオチドの類似体であり、lは、1〜40の整数であり、
ここで、
l=1である場合、Gは、グアノシン又はその類似体であり、
l>1である場合、ヌクレオチドの少なくとも50%がグアノシン又はその類似体であり、
ここで、
m=3である場合、 Xは、ウラシル又はその類似体であり、
m>3である場合、少なくとも3連続のウラシル又はウラシルの類似体が生じ、
nは、1〜40の整数であり、
ここで、
n=1である場合、Gは、グアノシン又はその類似体であり、
n>1である場合、ヌクレオチドの少なくとも50%がグアノシン又はその類似体である。
ここで、
Cは、シトシン、ウラシル、又はシトシンの類似体若しくはウラシルの類似体であり、Xは、グアノシン、ウラシル、アデノシン、チミジン、シトシン又は上記ヌクレオチドの類似体であり、lは、1〜40の整数であり、
ここで、
l=1である場合、Cは、シトシン又はその類似体であり、
l>1である場合、ヌクレオチドの少なくとも50%がシトシン又はその類似体であり、
mは、整数であり、少なくとも3であり、
ここで、
m=3である場合、Xは、ウラシル又はその類似体であり、
m>3である場合、少なくとも3連続のウラシル又はウラシルの類似体が生じ、
nは、1〜40の整数であり、
ここで、
n=1である場合、Cは、シトシン又はその類似体であり、
n>1である場合、ヌクレオチドの少なくとも50%がシトシン又はその類似体である。
GGGGGUUUUUUUUUUGGGGG(配列番号:290)、
GGGGGUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUGGGGG(配列番号:291)、
GUGUGUGUGUGUUUUUUUUUUUUUUUUGUGUGUGUGUGU(配列番号:292)、
GGUUGGUUGGUUUUUUUUUUUUUUUUUGGUUGGUUGGUU(配列番号:293)、
GGGGGGGGGUUUGGGGGGGG(配列番号:294)、
GGGGGGGGUUUUGGGGGGGG(配列番号:295)、
GGGGGGGUUUUUUGGGGGGG(配列番号:296)、
GGGGGGGUUUUUUUGGGGGG(配列番号:297)、
GGGGGGUUUUUUUUGGGGGG(配列番号:298)、
GGGGGGUUUUUUUUUGGGGG(配列番号:299)、
GGGGGGUUUUUUUUUUGGGG(配列番号:300)、
GGGGGUUUUUUUUUUUGGGG(配列番号:301)、
GGGGGUUUUUUUUUUUUGGG(配列番号:302)、
GGGGUUUUUUUUUUUUUGGG(配列番号:303)、
GGGGUUUUUUUUUUUUUUGG(配列番号:304)、
GGUUUUUUUUUUUUUUUUGG(配列番号:305)、
GUUUUUUUUUUUUUUUUUUG(配列番号:306)、
GGGGGGGGGGUUUGGGGGGGGG(配列番号:307)、
GGGGGGGGGUUUUGGGGGGGGG(配列番号:308)、
GGGGGGGGUUUUUUGGGGGGGG(配列番号:309)、
GGGGGGGGUUUUUUUGGGGGGG(配列番号:310)、
GGGGGGGUUUUUUUUGGGGGGG(配列番号:311)、
GGGGGGGUUUUUUUUUGGGGGG(配列番号:312)、
GGGGGGGUUUUUUUUUUGGGGG(配列番号:313)、
GGGGGGUUUUUUUUUUUGGGGG(配列番号:314)、
GGGGGGUUUUUUUUUUUUGGGG(配列番号:315)、
GGGGGUUUUUUUUUUUUUGGGG(配列番号:316)、
GGGGGUUUUUUUUUUUUUUGGG(配列番号:317)、
GGGUUUUUUUUUUUUUUUUGGG(配列番号:318)、
GGUUUUUUUUUUUUUUUUUUGG(配列番号:319)、
GGGGGGGGGGGUUUGGGGGGGGGG(配列番号:320)、
GGGGGGGGGGUUUUGGGGGGGGGG(配列番号:321)、
GGGGGGGGGUUUUUUGGGGGGGGG(配列番号:322)、
GGGGGGGGGUUUUUUUGGGGGGGG(配列番号:323)、
GGGGGGGGUUUUUUUUGGGGGGGG(配列番号:324)、
GGGGGGGGUUUUUUUUUGGGGGGG(配列番号:325)、
GGGGGGGGUUUUUUUUUUGGGGGG(配列番号:326)、
GGGGGGGUUUUUUUUUUUGGGGGG(配列番号:327)、
GGGGGGGUUUUUUUUUUUUGGGGG(配列番号:328)、
GGGGGGUUUUUUUUUUUUUGGGGG(配列番号:329)、
GGGGGGUUUUUUUUUUUUUUGGGG(配列番号:330)、
GGGGUUUUUUUUUUUUUUUUGGGG(配列番号:331)、
GGGUUUUUUUUUUUUUUUUUUGGG(配列番号:332)、
GUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUG(配列番号:333)、
GGUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUGG(配列番号:334)、
GGGUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUGGG(配列番号:335)、
GGGGUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUGGG(配列番号:336)、
GGGGGUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUGGGG(配列番号:337)、
GGGGGGUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUGGGGG(配列番号:338)、
GGGGGGGUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUGGGGGG(配列番号:339)、
GGGGGGGGUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUGGGGGGG(配列番号:340)、
GGGGGGGGGUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUGGGGGGGG(配列番号:341)、
GGUUUGG(配列番号:342)、
GGUUUUGG(配列番号:343)、
GGUUUUUGG(配列番号:344)、
GGUUUUUUGG(配列番号:345)、
GGUUUUUUUGG(配列番号:346)、
GGUUUUUUUUGG(配列番号:347)、
GGUUUUUUUUUGG(配列番号:348)、
GGUUUUUUUUUUGG(配列番号:349)、
GGUUUUUUUUUUUGG(配列番号:350)、
GGUUUUUUUUUUUUGG(配列番号:351)、
GGUUUUUUUUUUUUUGG(配列番号:352)、
GGUUUUUUUUUUUUUUGG(配列番号:353)、
GGUUUUUUUUUUUUUUUGG(配列番号:354)、
GGGUUUGGG(配列番号:355)、
GGGUUUUGGG(配列番号:356)、
GGGUUUUUGGG(配列番号:357)、
GGGUUUUUUGGG(配列番号:358)、
GGGUUUUUUUGGG(配列番号:359)、
GGGUUUUUUUUGGG(配列番号:360)、
GGGUUUUUUUUUGGG(配列番号:361)、
GGGUUUUUUUUUUGGG(配列番号:362)、
GGGUUUUUUUUUUUGGG(配列番号:363)、
GGGUUUUUUUUUUUUGGG(配列番号:364)、
GGGUUUUUUUUUUUUUGGG(配列番号:365)、
GGGUUUUUUUUUUUUUUUGGGUUUUUUUUUUUUUUUGGGUUUUUUUUUUUUUUUGGG(配列番号:366)、
GGGUUUUUUUUUUUUUUUGGGGGGUUUUUUUUUUUUUUUGGG(配列番号:367)、
GGGUUUGGGUUUGGGUUUGGGUUUGGGUUUGGGUUUGGGUUUGGGUUUGGG(配列番号:368)、
GGUUUUUUUUUUUUUUUGGG(短くGUに富む、配列番号:369)、又は、
CCCUUUCCCUUUCCCUUUCCCUUUCCCUUUCCCUUUCCCUUUCCCUUUCCC(配列番号:371)、
CCCUUUUUUUUUUUUUUUCCCCCCUUUUUUUUUUUUUUUCCC(配列番号:372)、
の配列のいずれかからなる、又はこれら配列のいずれかを含む配列から選択されてもよく、
Gは、グアノシン(グアニン)、ウリジン(ウラシル)、又はグアノシン(グアニン)の類似体若しくはウリジン(ウラシル)の類似体、好ましくはグアノシン(グアニン)又はその類似体であり、
Xは、グアノシン(グアニン)、ウリジン(ウラシル)、アデノシン(アデニン)、チミジン(チミン)、シチジン(シトシン)、又はこれらのヌクレオチド(ヌクレオシド)の類似体、好ましくはウリジン(ウラシル)又はその類似体であり、
Nは、約4〜50、好ましくは約4〜40核酸、より好ましくは約4〜30核酸又は4〜20核酸の長さを有する核酸配列であり、それぞれのNは、独立して、グアノシン(グアニン)、ウリジン(ウラシル)、アデノシン(アデニン)、チミジン(チミン)、シチジン(シトシン)、又はこれらのヌクレオチド(ヌクレオシド)の類似体から選択され、
aは、1〜20、好ましくは1〜15、最も好ましくは1〜10の整数であり、
lは、1〜40の整数であり、
ここで、
l=1である場合、Gは、グアノシン(グアニン)又はその類似体であり、
l>1である場合、これらのヌクレオチド(ヌクレオシド)の少なくとも50%がグアノシン(グアニン)又はその類似体であり、
mは、整数であり、少なくとも3であり、
ここで、
m=3である場合、Xは、ウリジン(ウラシル)又はその類似体であり、
m>3である場合、少なくとも3連続のウリジン(ウラシル)又はウリジン(ウラシル)の類似体が存在し、
nは、1〜40の整数であり、
ここで、
n=1である場合、Gは、グアノシン(グアニン)又はその類似体であり、
n>1である場合、こられのヌクレオチド(ヌクレオシド)の少なくとも50%がグアノシン(グアニン)又はその類似体であり、
u及びvは、互いに独立して、0〜50の整数であり、
好ましくは、ここで、u=0かつv≧1である場合、又はv=0かつu≧1である場合であり、
ここで、式(III)の核酸分子は、少なくとも50ヌクレオチド、好ましくは少なくとも100ヌクレオチド、より好ましくは少なくとも150ヌクレオチド、更により好ましくは200ヌクレオチド、及び最も好ましくは少なくとも250ヌクレオチドの長さを有する。
Cは、シチジン(シトシン)、ウリジン(ウラシル)、又はシチジン(シトシン)の類似体若しくはウリジン(ウラシル)の類似体、好ましくはシチジン(シトシン)又はその類似体であり、
Xは、グアノシン(グアニン)、ウリジン(ウラシル)、アデノシン(アデニン)、チミジン(チミン)、シチジン(シトシン)、又は上述のヌクレオチド(ヌクレオシド)の類似体、好ましくはウリジン(ウラシル)又はその類似体であり、
Nは、それぞれ、互いに独立して、約4〜50、好ましくは約4〜40核酸、より好ましくは約4〜30核酸又は4〜20核酸の長さを有する核酸配列であり、それぞれのNは、独立して、グアノシン(グアニン)、ウリジン(ウラシル)、アデノシン(アデニン)、チミジン(チミン)、シチジン(シトシン)、又はこれらのヌクレオチド(ヌクレオシド)の類似体から選択され、
aは、1〜20、好ましくは1〜15、最も好ましくは1〜10の整数であり、
lは、1〜40の整数であり、
ここで、
l=1である場合、Cは、シチジン(シトシン)又はその類似体であり、
l>1である場合、これらのヌクレオチド(ヌクレオシド)の少なくとも50%がシチジン(シトシン)又はその類似体であり、
mは、整数であり、少なくとも3であり、
ここで、
m=3である場合、Xは、ウリジン(ウラシル)又はその類似体であり、
m>3である場合、少なくとも3連続のウリジン(ウラシル)又はウリジン(ウラシル)の類似体が存在し、
nは、1〜40の整数であり、
ここで、
n=1である場合、Cは、シチジン(シトシン)又はその類似体であり、
n>1である場合、これらのヌクレオチド(ヌクレオシド)の少なくとも50%がシチジン(シトシン)又はその類似体であり、
u及びvは、互いに独立して、0〜50の整数であり、
好ましくは、ここで、u=0かつv≧1である場合、又はv=0かつu≧1である場合であり、
ここで、本発明の係る式(IV)の核酸分子は、少なくとも50ヌクレオチド、好ましくは少なくとも100ヌクレオチド、より好ましくは少なくとも150ヌクレオチド、更により好ましくは200ヌクレオチド、及び最も好ましくは少なくとも250ヌクレオチドの長さを有する。
本実施例のために、PR8 H1 HA(インフルエンザウイルスA/プエルトリコ/8/1934のヘマグルチニン)(配列番号:384)、及び対照群としてのニワトリオボアルブミン(対照群のmRNA)(配列番号:385)をそれぞれコードするDNA配列を調製し、後続のインビボの転写反応に使用した。
この実験では、新生児又は8週齢のマウスを、PR8 H1 HA(インフルエンザウイルスA/プエルトリコ/8/1934のヘマグルチニン、図1B)をコードする80μgのmRNAか、又は対照群としてのニワトリオボアルブミン(対照群のmRNA、図1C)コードするmRNAで二回皮内接種した。第1の注射は、生まれて初日(24時間以内)及び8週でぞれぞれ行った。最後のワクチン接種の5週間後、マウスを半数致死量の10倍のPR8ウイルス(10 LD50)に曝露した。マウスの体重を2週間に渡って制御し、元の重量の25%以上が失われたときにマウスを屠殺した。その結果を、図1Aに示す。図1Aは、実験におけるマウスの体重の推移を示している。結果として、PR8 H1ヘマグルチニンをコードするmRNAでワクチン接種を受けたマウスは、対照群mRNAのみでのインフルエンザ曝露感染(対象実験における全てのマウスが、初日にニワトリオボアルブミンをコードする対照群mRNAでワクチン接種を行った場合は、対照群mRNAでのワクチン接種の後、約5日で死亡し、8週で対照群mRNAでワクチン接種を行った場合は、対照群mRNAでのワクチン接種の後、約6日で死亡した)に対して、有意に良好な生存率を示した(全てのマウスが生存した)。全てのワクチン接種を受けた新生児マウスは、コントロールとは対照的に、PR8 H1ヘマグルチニンでの抗原投与を生き残った。
Claims (15)
- 2歳以下の年齢を示す新生児及び乳幼児の少なくともいずれかにおける疾患の予防及び治療の少なくともいずれかにおける使用のための、少なくとも1つの抗原をコードする少なくとも1つのmRNAを含むワクチンであって、前記治療が、前記新生児又は乳幼児のワクチン接種を含み、前記新生児又は乳幼児における免疫応答を誘発することを特徴とするワクチン。
- 患者における免疫応答の誘発が、Th1免疫応答を誘発することを含む請求項1に記載の使用のためのワクチン。
- 新生児又は乳幼児が、1)男性又は女性、哺乳動物、又はヒトである、又は、2)3歳以下、2歳以下、1.5歳以下、1歳(12ヶ月)以下、9ヶ月以下、6ヶ月以下又は3ヶ月以下の年齢を示す、或いは1)及び2)の両方である請求項1又は2に記載の使用のためのワクチン。
- 疾患が、感染症、ウイルス性感染症、細菌性感染症又は原虫性感染症、自己免疫疾患、アレルギー又はアレルギー性疾患、又は癌又は腫瘍疾患から選択される請求項1から3のいずれかに記載の使用のためのワクチン。
- 抗原が、タンパク質抗原及びペプチド抗原、腫瘍抗原、自己抗原(self−antigen)又は自己抗原(auto−antigen)、自己免疫自己抗原、病原性抗原、ウイルス抗原、細菌抗原、真菌抗原、原生生物抗原、動物抗原、及びアレルギー抗原から選択される請求項1から4のいずれかに記載の使用のためのワクチン。
- ワクチンが、非経口で、経口で、経鼻で、経肺で、吸入で、局所的に、経直腸的に、口腔的に、経膣的に、又は埋込み型容器を介して投与される請求項1から5のいずれかに記載の使用のためのワクチン。
- 少なくとも1つの抗原をコードする少なくとも1つのmRNAが、そのネイキッドの形態で投与されるか、又はカチオン性又はポリカチオン性の化合物と伴うか又は複合体化される請求項1から6のいずれかに記載の使用のためのワクチン。
- 少なくとも1つの抗原をコードする少なくとも1つのmRNAが、以下の合計式(I)を有する以下のオリゴペプチドから選択されるか、繰り返し単位として以下の下位式(Ia)を有するオリゴペプチドを含むジスルフィド架橋したカチオン成分から選択されるか、又は繰り返し単位として以下の下位式(Ib)を有するオリゴペプチドを含むジスルフィド架橋したカチオン成分から選択されるジスルフィド架橋したカチオン性成分によって形成されるポリマー担体と複合体を形成しており、
{(Arg)l;(Lys)m;(His)n;(Orn)o;(Xaa)x} 式(I)
ここで、l+m+n+o+x=3〜100であり、l、m、n又はoは、互いに独立して、0、1、2、3、4、5、6、7、8、9、10、11、12、13、14、15、16、17、18、19、20、21〜30、31〜40、41〜50、51〜60、61〜70、71〜80、81〜90及び91〜100から選択される任意の数であり(但し、Arg(アルギニン)、Lys(リジン)、His(ヒスチジン)及びOrn(オルニチン)の総含有量が式(V)のオリゴペプチドの全アミノ酸の少なくとも10%を占める)、Xaaは、Arg、Lys、His又はOrnを除くネイティブの(天然の)又は非ネイティブのアミノ酸から選択され、xは、0、1、2、3、4、5、6、7、8、9、10、11、12、13、14、15、16、17、18、19、20、21〜30、31〜40、41〜50、51〜60、61〜70、71〜80及び81〜90から選択される任意の数であり(但し、Xaaの総含有量が式(I)のオリゴペプチドの全アミノ酸の90%を超えない)、
{(Arg)l;(Lys)m;(His)n;(Orn)o;(Xaa’)x(Cys)y} 式(Ia)
ここで、(Arg)l;(Lys)m;(His)n;(Orn)o;及びxは、好ましくは式(I)に対して上記で定義したものであり、Xaa’は、Arg、Lys、His、Orn又はCysを除くネイティブの(天然の)又は非ネイティブのアミノ酸から選択され、yは、0、1、2、3、4、5、6、7、8、9、10、11、12、13、14、15、16、17、18、19、20、21〜30、31〜40、41〜50、51〜60、61〜70、71〜80及び81〜90から選択される任意の数であり(但し、Arg(アルギニン)、Lys(リジン)、His(ヒスチジン)及びOrn(オルニチン)の総含有量がオリゴペプチドの全アミノ酸の少なくとも10%を占める)、
Cys1{(Arg)l;(Lys)m;(His)n;(Orn)o;(Xaa)x}Cys2 式(Ib)
ここで、式(Ib)中の成分{(Arg)l;(Lys)m;(His)n;(Orn)o;(Xaa)x}(式(I))は、本明細書中で定義するものであり、下位式(Ib)の中核部を形成し、Cys1及びCys2は、(Arg)l;(Lys)m;(His)n;(Orn)o;(Xaa)xの近位又は末端にあるシステインである、
請求項1から6のいずれかに記載の使用のためのワクチン。 - 少なくとも1つの抗原をコードする少なくとも1つのmRNAが、一般式(VI)で表されるポリマー担体と複合体を形成しており、
L−P1−S−[S−P2−S]n−S−P3−L 一般式(VI)
ここで、
P1及びP3は、互いに異なるか又は同一であり、直鎖状又は分枝状の親水性ポリマー鎖を表し、各々のP1及びP3は、成分P2との縮合によりジスルフィド結合を形成可能な、少なくとも1つの−SH部分を提示し、前記直鎖状又は分枝状の親水性ポリマー鎖は、互いに独立して、ポリエチレングリコール(PEG)、ポリ−N−(2−ヒドロキシプロピル)メタクリルアミド、ポリ−2−(メタクリロイルオキシ)エチルホスホリルコリン、ポリ(ヒドロキシアルキルL−アスパラギン)、ポリ(2−(メタクリロイルオキシ)エチルホスホリルコリン)、ヒドロキシエチルデンプン、又はポリ(ヒドロキシアルキルL−グルタミン)から選択され、ここで、前記親水性ポリマー鎖は、約1kDa〜約100kDaの分子量を示し、
P2は、約3〜100アミノ酸長を有するカチオン性又はポリカチオン性のペプチド又はタンパク質であるか、又は、P2は、約0.5kDa〜約30kDaの分子量を有するカチオン性又はポリカチオン性のポリマーであり、各P2は、更なる成分P2、又は成分P1及び成分P3の少なくともいずれかとの縮合によりジスルフィド結合を形成可能な少なくとも2つの−SH部分を提示し、
−S−S−は、(可逆の)ジスルフィド結合であり、
Lは、存在してもしなくてもよい任意的なリガンドであり、互いに独立して、RGD、トランスフェリン、葉酸、シグナルペプチド又はシグナル配列、局在化シグナル又は局在化配列、核酸局在化シグナル又は核酸局在化配列(NLS)、抗体、細胞透過性ペプチド(CPP)、TAT、KALA、受容体のリガンド、サイトカイン、ホルモン、成長因子、小分子、炭水化物、マンノース、ガラクトース、合成リガンド、小分子アゴニスト、受容体の阻害剤又はアンタゴニスト、又はRGDペプチド模倣薬類似体から選択され、
nは、約1〜50の範囲、好ましくは約1、2、3、4又は5〜10の範囲、より好ましくは約1、2、3又は4〜9の範囲から選択される整数である、
請求項1から6のいずれかに記載の使用のためのワクチン。 - 少なくとも1つの抗原をコードする少なくとも1つのmRNAが、式(VIa)で表されるポリマー担体と複合体を形成しており、
L−P1−S−{[S−P2−S]a[S−(AA)x−S]b}−S−P3−L 式(VIa)
ここで、S、L、P1、P2及びP3は、好ましくは式(VI)に対して上記で定義したものであり、
a及びbは、整数であり、ここで、a+b=nであり、nは式(VI)に対して上記で定義したものであり、
xは、約1〜100の範囲から選択される整数であり、
(AA)は、芳香族、親水性、親油性、又は弱塩基性のアミノ酸又はペプチドから選択されるか、シグナルペプチド又はシグナル配列、局在化シグナル又は局在化配列、核酸局在化シグナル又は核酸局在化配列(NLS)、抗体、又は細胞透過性ペプチド(CPP)であるか、抗原由来、腫瘍抗原由来、病原性抗原由来、動物抗原由来、ウイルス抗原由来、原生動物抗原由来、細菌抗原由来、アレルギー性抗原由来、自己免疫抗原由来、アレルゲン由来、抗体由来、免疫刺激性のタンパク質又はペプチド由来、又は抗原特異的T細胞受容体由来の治療効果のあるタンパク質又はペプチドから選択される、
請求項9に記載の使用のためのワクチン。 - ワクチンが、a)カチオン性又はポリカチオン性の化合物、及び請求項7又は8のいずれかに従って定義するポリマー担体の少なくともいずれかと複合体を形成した少なくとも1つの(m)RNAを含む、又はこれらからなる(アジュバント)成分と、b)請求項1及び5のいずれかに従って定義する抗原をコードする少なくとも1つの遊離mRNAと、を含むように製剤化される請求項1から10のいずれかに記載の使用のためのワクチン。
- (m)RNAが、請求項1から5のいずれかに従って定義するmRNA、免疫刺激性核酸、CpG核酸、CpG−RNA、CpG−DNA、又は免疫刺激性RNA(isRNA)である請求項11に記載の使用のためのワクチン。
- ワクチンが、薬学的に許容される担体及び賦形剤の少なくともいずれかを更に含む請求項1から12のいずれかに記載の使用のためのワクチン。
- ワクチンが、リポ多糖、TNF−α、CD40リガンド、又は、サイトカイン、モノカイン、リンホカイン、インターロイキン又はケモカイン、IL−1、IL−2、IL−3、IL−4、IL−5、IL−6、IL−7、IL−8、IL−9、IL−10、IL−12、IL−13、IL−14、IL−15、IL−16、IL−17、IL−18、IL−19、IL−20、IL−21、IL−22、IL−23、IL−24、IL−25、IL−26、IL−27、IL−28、IL−29、IL−30、IL−31、IL−32、IL−33、IFNα、IFNβ、IFNγ、GM−CSF、G−CSF、M−CSF、LT−β、TNF−α、成長因子、及びhGH、ヒトのトール様受容体TLR1、TLR2、TLR3、TLR4、TLR5、TLR6、TLR7、TLR8、TLR9又はTLR10のリガンド、マウスのトール様受容体TLR1、TLR2、TLR3、TLR4、TLR5、TLR6、TLR7、TLR8、TLR9、TLR10、TLR11、TLR12又はTLR13のリガンド、NOD様受容体のリガンド、RIG−I様受容体のリガンド、免疫刺激性核酸、免疫刺激性RNA(isRNA)、CpG−DNA、抗菌剤、又は抗ウイルス剤から選択される補助物質又はアジュバントの少なくとも1種を更に含む請求項1から12のいずれかに記載の使用のためのワクチン。
- 請求項1から14のいずれかに従って定義するワクチンを含むキットであって、少なくとも1つの抗原をコードする各mRNAが、キットの別の部分に設けられていることを特徴とするキット。
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JP2014508152A (ja) | 2014-04-03 |
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