JPWO2021207615A5 - - Google Patents
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- JPWO2021207615A5 JPWO2021207615A5 JP2022561414A JP2022561414A JPWO2021207615A5 JP WO2021207615 A5 JPWO2021207615 A5 JP WO2021207615A5 JP 2022561414 A JP2022561414 A JP 2022561414A JP 2022561414 A JP2022561414 A JP 2022561414A JP WO2021207615 A5 JPWO2021207615 A5 JP WO2021207615A5
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- 102000037865 fusion proteins Human genes 0.000 claims description 66
- 108020001507 fusion proteins Proteins 0.000 claims description 66
- 230000028993 immune response Effects 0.000 claims description 12
- 238000000034 method Methods 0.000 claims description 8
- 208000016604 Lyme disease Diseases 0.000 claims description 7
- 239000002671 adjuvant Substances 0.000 claims description 7
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims description 6
- 108700006640 OspA Proteins 0.000 claims description 5
- 241000589968 Borrelia Species 0.000 claims description 4
- 230000000844 anti-bacterial effect Effects 0.000 claims description 4
- 230000002459 sustained effect Effects 0.000 claims description 4
- 230000005875 antibody response Effects 0.000 claims description 3
- 102000004169 proteins and genes Human genes 0.000 claims description 3
- 108090000623 proteins and genes Proteins 0.000 claims description 3
- 230000003053 immunization Effects 0.000 claims description 2
- 238000002649 immunization Methods 0.000 claims description 2
- 150000001875 compounds Chemical class 0.000 description 12
- 239000010949 copper Substances 0.000 description 10
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 8
- 229910052802 copper Inorganic materials 0.000 description 8
- FFEARJCKVFRZRR-UHFFFAOYSA-N L-Methionine Natural products CSCCC(N)C(O)=O FFEARJCKVFRZRR-UHFFFAOYSA-N 0.000 description 6
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 description 6
- 229930195722 L-methionine Natural products 0.000 description 6
- 229960004452 methionine Drugs 0.000 description 6
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 4
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 4
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 4
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 4
- 229910052782 aluminium Inorganic materials 0.000 description 4
- 229960005486 vaccine Drugs 0.000 description 3
- 229910004879 Na2S2O5 Inorganic materials 0.000 description 2
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 description 2
- 229920001213 Polysorbate 20 Polymers 0.000 description 2
- LSNNMFCWUKXFEE-UHFFFAOYSA-N Sulfurous acid Chemical compound OS(O)=O LSNNMFCWUKXFEE-UHFFFAOYSA-N 0.000 description 2
- XSTXAVWGXDQKEL-UHFFFAOYSA-N Trichloroethylene Chemical group ClC=C(Cl)Cl XSTXAVWGXDQKEL-UHFFFAOYSA-N 0.000 description 2
- 239000013504 Triton X-100 Substances 0.000 description 2
- 229920004890 Triton X-100 Polymers 0.000 description 2
- 229920001577 copolymer Polymers 0.000 description 2
- 229940009976 deoxycholate Drugs 0.000 description 2
- KXGVEGMKQFWNSR-LLQZFEROSA-N deoxycholic acid Chemical compound C([C@H]1CC2)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@@H](CCC(O)=O)C)[C@@]2(C)[C@@H](O)C1 KXGVEGMKQFWNSR-LLQZFEROSA-N 0.000 description 2
- FFYPMLJYZAEMQB-UHFFFAOYSA-N diethyl pyrocarbonate Chemical compound CCOC(=O)OC(=O)OCC FFYPMLJYZAEMQB-UHFFFAOYSA-N 0.000 description 2
- WSFSSNUMVMOOMR-NJFSPNSNSA-N methanone Chemical compound O=[14CH2] WSFSSNUMVMOOMR-NJFSPNSNSA-N 0.000 description 2
- 229920001983 poloxamer Polymers 0.000 description 2
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 description 2
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 description 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 2
- 229920000136 polysorbate Polymers 0.000 description 2
- 229920000053 polysorbate 80 Polymers 0.000 description 2
- 229940068965 polysorbates Drugs 0.000 description 2
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 description 2
- 235000010262 sodium metabisulphite Nutrition 0.000 description 2
- 230000000087 stabilizing effect Effects 0.000 description 2
- UBOXGVDOUJQMTN-UHFFFAOYSA-N trichloroethylene Natural products ClCC(Cl)Cl UBOXGVDOUJQMTN-UHFFFAOYSA-N 0.000 description 2
- 241000589970 Spirochaetales Species 0.000 description 1
- 230000010534 mechanism of action Effects 0.000 description 1
Description
OspAベースのワクチンは、その作用の機序（体の外側）のために、高いかつ持続される抗体価を必要とする。
[本発明1001]
ワクチンにおける使用のための、SEQ ID NO: 1の融合タンパク質（Lip-S1D1-S2D1）とSEQ ID NO: 2の融合タンパク質（Lip-S4D1-S3hybD1）とSEQ ID NO: 3の融合タンパク質（Lip-S5D1-S6D1）とを含む組成物であって、
前記ワクチンが、
- ヒト成人もしくはヒト小児に少なくとも3回、用量当たり120～200μgの範囲内の、3つの前記融合タンパク質の総タンパク質含量で；または
- ヒト小児に少なくとも3回、用量当たり60～100μgの範囲内の、3つの前記融合タンパク質の総タンパク質含量で
投与されることになる、前記組成物。
[本発明1002]
ライム病に対してヒトにおいて免疫応答を惹起するための方法における使用のための、SEQ ID NO: 1の融合タンパク質（Lip-S1D1-S2D1）とSEQ ID NO: 2の融合タンパク質（Lip-S4D1-S3hybD1）とSEQ ID NO: 3の融合タンパク質（Lip-S5D1-S6D1）とを含む組成物であって、
前記方法が、
- ヒト成人もしくはヒト小児に少なくとも3回、用量当たり120～200μgの範囲内の、3つの前記融合タンパク質の総タンパク質含量で；または
- ヒト小児に少なくとも3回、用量当たり60～100μgの範囲内の、3つの前記融合タンパク質の総タンパク質含量で
前記組成物を投与する工程を含む、前記組成物。
[本発明1003]
2回目の投与が、1回目の投与後少なくとも6週から多くても3ヶ月までの期間中であり、かつ/または3回目の投与が、1回目の投与後少なくとも5ヶ月から多くても7ヶ月までの期間中である、本発明1001または1002の使用のための組成物。
[本発明1004]
2回目の投与が、1回目の投与後、少なくとも50日から多くても70日までの期間中、特に少なくとも55日から多くても60日までの期間中、とりわけ56日であり；かつ/または3回目の投与が、1回目の投与後、少なくとも170日から多くても190日までの期間中、少なくとも175日から多くても185日までの期間中、とりわけ180日である、本発明1001～1003のいずれかの使用のための組成物。
[本発明1005]
前記組成物の4回目の投与が、1回目の投与後、少なくとも15ヶ月から多くても21ヶ月までの期間中、特に少なくとも17ヶ月から多くても19ヶ月までの期間中、とりわけ18ヶ月である、本発明1001～1004のいずれかの使用のための組成物。
[本発明1006]
3つの前記融合タンパク質の総タンパク質含量が、ヒト成人もしくは小児に対して用量当たり135μg～180μgの範囲内、特に用量当たり135μgもしくは180μgであるか、または3つの前記融合タンパク質の総タンパク質含量が、幼い小児に対して用量当たり67.5μg～90μgの範囲内、特に用量当たり67.5μgもしくは90μgである、本発明1001～1005のいずれかの使用のための組成物。
[本発明1007]
3つの前記融合タンパク質が、前記組成物中のすべてのタンパク質の少なくとも60％、好ましくは少なくとも70％、より好ましくは80％を構成する、本発明1001～1006のいずれかの使用のための組成物。
[本発明1008]
1:1:1（Lip-S1D1-S2D1 : Lip-S4D1-S3hybD1 : Lip-S5D1-S6D1）の重量比で前記融合タンパク質を含む、本発明1001～1007のいずれかの使用のための組成物。
[本発明1009]
アジュバントを含む、本発明1001～1008のいずれかの使用のための組成物。
[本発明1010]
アルミニウムアジュバント、好ましくは、低い銅含量を有するアルミニウムアジュバント、好ましくは、1.25 ppb未満の銅を有するアルミニウムアジュバントを含む、本発明1001～1009のいずれかの使用のための組成物。
[本発明1011]
3つの前記融合タンパク質の総タンパク質含量が、ヒト成人または小児に対して用量当たり135μgであり、2回目の投与が、1回目の投与の56日後であり、3回目の投与が、1回目の投与の180日後であり、かつ任意の4回目の投与が、1回目の投与の18ヶ月後である、本発明1001～1010のいずれかの使用のための組成物。
[本発明1012]
3つの前記融合タンパク質の総タンパク質含量が、幼い小児に対して用量当たり67.5μgであり、2回目の投与が、1回目の投与の56日後であり、3回目の投与が、1回目の投与の180日後であり、かつ任意の4回目の投与が、1回目の投与の18ヶ月後である、本発明1001～1010のいずれかの使用のための組成物。
[本発明1013]
3つの前記融合タンパク質の総タンパク質含量が、ヒト成人または小児に対して用量当たり180μgであり、2回目の投与が、1回目の投与の56日後であり、3回目の投与が、1回目の投与の180日後であり、かつ任意の4回目の投与が、1回目の投与の18ヶ月後である、本発明1001～1010のいずれかの使用のための組成物。
[本発明1014]
3つの前記融合タンパク質の総タンパク質含量が、幼い小児に対して用量当たり90μgであり、2回目の投与が、1回目の投与の56日後であり、3回目の投与が、1回目の投与の180日後であり、かつ任意の4回目の投与が、1回目の投与の18ヶ月後である、本発明1001～1010のいずれかの使用のための組成物。
[本発明1015]
3つの前記融合タンパク質の総タンパク質含量が、ヒト成人または小児に対して用量当たり135μgであり、2回目の投与が、1回目の投与の2ヶ月後であり、3回目の投与が、1回目の投与の6ヶ月後であり、かつ任意の4回目の投与が、1回目の投与の18ヶ月後である、本発明1001～1010のいずれかの使用のための組成物。
[本発明1016]
3つの前記融合タンパク質の総タンパク質含量が、幼い小児に対して用量当たり67.5μgであり、2回目の投与が、1回目の投与の2ヶ月後であり、3回目の投与が、1回目の投与の6ヶ月後であり、かつ任意の4回目の投与が、1回目の投与の18ヶ月後である、本発明1001～1010のいずれかの使用のための組成物。
[本発明1017]
3つの前記融合タンパク質の総タンパク質含量が、ヒト成人または小児に対して用量当たり180μgであり、2回目の投与が、1回目の投与の2ヶ月後であり、3回目の投与が、1回目の投与の6ヶ月後であり、かつ任意の4回目の投与が、1回目の投与の18ヶ月後である、本発明1001～1010のいずれかの使用のための組成物。
[本発明1018]
3つの前記融合タンパク質の総タンパク質含量が、幼い小児に対して用量当たり90μgであり、2回目の投与が、1回目の投与の2ヶ月後であり、3回目の投与が、1回目の投与の6ヶ月後であり、かつ任意の4回目の投与が、1回目の投与の18ヶ月後である、本発明1001～1010のいずれかの使用のための組成物。
[本発明1019]
さらなる投与が、3回目の投与後毎年、特に、1年後、2年後、および3年後である、本発明1001～1018のいずれかの使用のための組成物。
[本発明1020]
惹起される前記免疫応答が、殺菌活性を有する抗OspA血清型1、抗OspA血清型2、抗OspA血清型3、抗OspA血清型4、抗OspA血清型5、および/または抗OspA血清型6の抗体応答を含む、本発明1001～1019のいずれかの使用のための組成物。
[本発明1021]
惹起される前記免疫応答が、ボレリア血清型1、2、3、4、5、および6に対する抗体を含む、本発明1001～1020のいずれかの使用のための組成物。
[本発明1022]
ボレリア血清型1、2、3、4、5、および6に対する前記免疫応答が、少なくとも約60日間、少なくとも約180日間、少なくとも約365日間、または少なくとも約540日間持続される、本発明1001～1021のいずれかの使用のための組成物。
[本発明1023]
1.25 ppb未満の銅または十分な量のL-メチオニンを含む、本発明1001～1022のいずれかの使用のための組成物。
[本発明1024]
銅が、特にCu
+
またはCu
2+
としての、イオンの形態である、本発明1001～1023のいずれかの使用のための組成物。
[本発明1025]
L-メチオニンが少なくとも10 mmol/lの濃度で存在する、本発明1001～1024のいずれかの使用のための組成物。
[本発明1026]
L-メチオニンのmol/l単位の濃度が、前記組成物中において銅の濃度と少なくとも等価である、本発明1023～1025のいずれかの使用のための組成物。
[本発明1027]
反応性化合物をさらに含み、前記反応性化合物が、酸化還元活性化合物、ラジカル構成化合物（radical building compound）、安定化化合物、および任意のそれらの組み合わせからなる群より選択され、とりわけ、前記反応性化合物が、ホルムアルデヒド、エタノール、クロロホルム、トリクロロエチレン、アセトン、triton-X-100、デオキシコラート、ジエチルピロカルボナート、サルファイト、Na
2
S
2
O
5
、β-プロプリオ-ラクトン（beta-proprio-lacton）、ポリソルベート、例えばTween 20（登録商標）、Tween 80（登録商標）、O
2
、フェノール、pluronic型コポリマー、および任意のそれらの組み合わせからなる群より選択される、本発明1001～1026のいずれかの使用のための組成物。
[本発明1028]
前記ヒト成人が、18歳またはそれ以上、例えば18～65歳の対象である、本発明1001～1027のいずれかの使用のための組成物。
[本発明1029]
前記ヒト成人が、50歳またはそれ以上である年配の対象である、本発明1001～1027のいずれかの使用のための組成物。
[本発明1030]
前記ヒト小児が、5～17歳、例えば12～17歳または5～11歳の対象である、本発明1001～1027のいずれかの使用のための組成物。
[本発明1031]
前記ヒト小児が、0～4歳、例えば1～4歳または2～4歳の対象である、本発明1001～1027のいずれかの使用のための組成物。
[本発明1032]
ヒト成人または小児に、0.25ミリリットル（ml）～1.0 ml、例えば0.25 ml、0.3 ml、0.4 ml、0.5 ml、0.6 ml、0.7 ml、0.8 ml、0.9 ml、または1.0 mlの体積で投与される、本発明1001～1031のいずれかの使用のための組成物。
[本発明1033]
ヒト成人または小児に、0.25 ml、0.5 ml、または1.0 mlの体積で投与される、本発明1001～1032のいずれかの使用のための組成物。
[本発明1034]
ヒトにワクチン接種するための使用のための組成物であって、
前記方法が、SEQ ID NO: 1の融合タンパク質（Lip-S1D1-S2D1）とSEQ ID NO: 2の融合タンパク質（Lip-S4D1-S3hybD1）とSEQ ID NO: 3の融合タンパク質（Lip-S5D1-S6D1）とを含む組成物を、
- ヒト成人もしくはヒト小児に少なくとも2回、用量当たり120～200μgの範囲内の、3つの前記融合タンパク質の総タンパク質含量で；または
- ヒト小児に少なくとも2回、用量当たり60～100μgの範囲内の、3つの前記融合タンパク質の総タンパク質含量で
投与する工程を含む、前記組成物。
[本発明1035]
ライム病に対してヒトにおいて免疫応答を惹起するための使用のための組成物であって、
前記方法が、SEQ ID NO: 1の融合タンパク質（Lip-S1D1-S2D1）とSEQ ID NO: 2の融合タンパク質（Lip-S4D1-S3hybD1）とSEQ ID NO: 3の融合タンパク質（Lip-S5D1-S6D1）とを含む組成物を、
- ヒト成人もしくはヒト小児に少なくとも2回、用量当たり120～200μgの範囲内の、3つの前記融合タンパク質の総タンパク質含量で；または
- ヒト小児に少なくとも2回、用量当たり60～100μgの範囲内の、3つの前記融合タンパク質の総タンパク質含量で
投与する工程を含む、前記組成物。
[本発明1036]
2回目の投与が、1回目の投与後少なくとも5ヶ月から多くても7ヶ月までの期間中である、本発明1034または本発明1035の使用のための組成物。
[本発明1037]
2回目の投与が、1回目の投与後、少なくとも170日から多くても190日までの期間中、少なくとも175日から多くても185日までの期間中、とりわけ180日である、本発明1034～1036のいずれかの使用のための組成物。
[本発明1038]
前記組成物の3回目の投与が、1回目の投与後、少なくとも15ヶ月から多くても21ヶ月までの期間中、特に少なくとも17ヶ月から多くても19ヶ月までの期間中、とりわけ18ヶ月である、本発明1034～1037のいずれかの使用のための組成物。
[本発明1039]
3つの前記融合タンパク質の総タンパク質含量が、ヒト成人もしくは小児に対して用量当たり135μg～180μgの範囲内、特に用量当たり135μgもしくは180μgであるか、または3つの前記融合タンパク質の総タンパク質含量が、幼い小児に対して用量当たり67.5μg～90μgの範囲内、特に用量当たり67.5μgもしくは90μgである、本発明1034～1038のいずれかの使用のための組成物。
[本発明1040]
3つの前記融合タンパク質が、前記組成物中のすべてのタンパク質の少なくとも60％、好ましくは少なくとも70％、より好ましくは少なくとも80％を構成する、本発明1034～1039のいずれかの使用のための組成物。
[本発明1041]
1:1:1（Lip-S1D1-S2D1 : Lip-S4D1-S3hybD1 : Lip-S5D1-S6D1）の重量比で前記融合タンパク質を含む、本発明1034～1040のいずれかの使用のための組成物。
[本発明1042]
アジュバントを含む、本発明1034～1041のいずれかの使用のための組成物。
[本発明1043]
アルミニウムアジュバントを含む、本発明1034～1042のいずれかの使用のための組成物。
[本発明1044]
3つの前記融合タンパク質の総タンパク質含量が、ヒト成人または小児に対して用量当たり135μgであり、2回目の投与が、1回目の投与の180日後であり、かつ、任意の3回目の投与が、1回目の投与の18ヶ月後であり、かつ任意で、その後12ヶ月ごとである、本発明1034～1043のいずれかの使用のための組成物。
[本発明1045]
3つの前記融合タンパク質の総タンパク質含量が、幼い小児に対して用量当たり67.5μgであり、2回目の投与が、1回目の投与の180日後であり、かつ、任意の3回目の投与が、1回目の投与の18ヶ月後であり、かつ任意で、その後12ヶ月ごとである、本発明1034～1043のいずれかの使用のための組成物。
[本発明1046]
3つの前記融合タンパク質の総タンパク質含量が、ヒト成人または小児に対して用量当たり180μgであり、2回目の投与が、1回目の投与の180日後であり、かつ、任意の3回目の投与が、1回目の投与の18ヶ月後であり、かつ任意で、その後12ヶ月ごとである、本発明1034～1043のいずれかの使用のための組成物。
[本発明1047]
3つの前記融合タンパク質の総タンパク質含量が、幼い小児に対して用量当たり90μgであり、2回目の投与が、1回目の投与の180日後であり、かつ、任意の3回目の投与が、1回目の投与の18ヶ月後であり、かつ任意で、その後12ヶ月ごとである、本発明1034～1043のいずれかの使用のための組成物。
[本発明1048]
3つの前記融合タンパク質の総タンパク質含量が、ヒト成人または小児に対して用量当たり135μgであり、2回目の投与が、1回目の投与の6ヶ月後であり、かつ、任意の3回目の投与が、1回目の投与の18ヶ月後であり、かつ任意で、その後12ヶ月ごとである、本発明1034～1043のいずれかの使用のための組成物。
[本発明1049]
3つの前記融合タンパク質の総タンパク質含量が、幼い小児に対して用量当たり67.5μgであり、2回目の投与が、1回目の投与の6ヶ月後であり、かつ、任意の3回目の投与が、1回目の投与の18ヶ月後であり、かつ任意で、その後12ヶ月ごとである、本発明1034～1043のいずれかの使用のための組成物。
[本発明1050]
3つの前記融合タンパク質の総タンパク質含量が、ヒト成人または小児に対して用量当たり180μgであり、2回目の投与が、1回目の投与の6ヶ月後であり、かつ、任意の3回目の投与が、1回目の投与の18ヶ月後であり、かつ任意で、その後12ヶ月ごとである、本発明1034～1043のいずれかの使用のための組成物。
[本発明1051]
3つの前記融合タンパク質の総タンパク質含量が、幼い小児に対して用量当たり90μgであり、2回目の投与が、1回目の投与の6ヶ月後であり、かつ、任意の3回目の投与が、1回目の投与の18ヶ月後であり、かつ任意で、その後12ヶ月ごとである、本発明1034～1043のいずれかの使用のための組成物。
[本発明1052]
さらなる投与が、最後の一次免疫処置の後毎年、または各々のダニ季節の初め、特に、1年後、2年後、および3年後などである、本発明1034～1051のいずれかの使用のための組成物。
[本発明1053]
惹起される前記免疫応答が、殺菌活性を有する抗OspA血清型1、抗OspA血清型2、抗OspA血清型3、抗OspA血清型4、抗OspA血清型5、および/または抗OspA血清型6の抗体応答を含む、本発明1034～1052のいずれかの使用のための組成物。
[本発明1054]
惹起される前記免疫応答が、OspA血清型1、2、3、4、5、および6を発現するスピロヘータに対して殺菌活性を有する抗体を含む、本発明1034～1053のいずれかの使用のための組成物。
[本発明1055]
OspA血清型1、2、3、4、5、および6に対する前記免疫応答が、少なくとも約60日間、少なくとも約180日間、少なくとも約365日間、または少なくとも約540日間持続される、本発明1034～1054のいずれかの使用のための組成物。
[本発明1056]
1.25 ppb未満の銅または十分な量のL-メチオニンを含む、本発明1034～1055のいずれかの使用のための組成物。
[本発明1057]
銅が、特にCu
+
またはCu
2+
としての、イオンの形態である、本発明1034～1056のいずれかの使用のための組成物。
[本発明1058]
L-メチオニンが少なくとも10 mmol/lの濃度で存在する、本発明1034～1057のいずれかの使用のための組成物。
[本発明1059]
L-メチオニンのmol/l単位の濃度が、前記組成物中において銅の濃度と少なくとも等価である、本発明1056～1058のいずれかの使用のための組成物。
[本発明1060]
反応性化合物をさらに含み、前記反応性化合物が、酸化還元活性化合物、ラジカル構成化合物、安定化化合物、および任意のそれらの組み合わせからなる群より選択され、とりわけ、前記反応性化合物が、ホルムアルデヒド、エタノール、クロロホルム、トリクロロエチレン、アセトン、triton-X-100、デオキシコラート、ジエチルピロカルボナート、サルファイト、Na
2
S
2
O
5
、β-プロプリオ-ラクトン、ポリソルベート、例えばTween 20（登録商標）、Tween 80（登録商標）、O
2
、フェノール、pluronic型コポリマー、および任意のそれらの組み合わせからなる群より選択される、本発明1034～1059のいずれかの使用のための組成物。
[本発明1061]
前記ヒト成人が、18歳またはそれ以上、例えば18～65歳の対象である、本発明1034～1060のいずれかの使用のための組成物。
[本発明1062]
前記ヒト成人が、50歳またはそれ以上である年配の対象である、本発明1034～1060のいずれかの使用のための組成物。
[本発明1063]
前記ヒト小児が、5～17歳、例えば12～17歳または5～11歳の対象である、本発明1034～1060のいずれかの使用のための組成物。
[本発明1064]
前記ヒト小児が、0～4歳、例えば1～4歳または2～4歳の対象である、本発明1034～1060のいずれかの使用のための組成物。
[本発明1065]
ヒト成人または小児に、0.25ミリリットル（ml）～1.0 ml、例えば0.25 ml、0.3 ml、0.4 ml、0.5 ml、0.6 ml、0.7 ml、0.8 ml、0.9 ml、または1.0 mlの体積で投与される、本発明1034～1064のいずれかの使用のための組成物。
[本発明1066]
ヒト成人または小児に、0.25 ml、0.5 ml、または1.0 mlの体積で投与される、本発明1034～1065のいずれかの使用のための組成物。
An OspA-based vaccine requires high and sustained antibody titres due to its mechanism of action (outside the body).
[The present invention 1001]
A composition comprising a fusion protein of SEQ ID NO: 1 (Lip-S1D1-S2D1), a fusion protein of SEQ ID NO: 2 (Lip-S4D1-S3hybD1) and a fusion protein of SEQ ID NO: 3 (Lip-S5D1-S6D1) for use in a vaccine,
The vaccine,
- at least three times to a human adult or a human child, with a total protein content of the three fusion proteins in the range of 120-200 μg per dose; or
- at least three doses to a human child, with a total protein content of the three fusion proteins in the range of 60-100 μg per dose;
The composition to be administered.
[The present invention 1002]
1. A composition comprising a fusion protein of SEQ ID NO: 1 (Lip-S1D1-S2D1), a fusion protein of SEQ ID NO: 2 (Lip-S4D1-S3hybD1) and a fusion protein of SEQ ID NO: 3 (Lip-S5D1-S6D1) for use in a method for raising an immune response in a human against Lyme disease, the composition comprising:
The method,
- at least three times to a human adult or a human child, with a total protein content of the three fusion proteins in the range of 120-200 μg per dose; or
- at least three doses to a human child, with a total protein content of the three fusion proteins in the range of 60-100 μg per dose;
The composition comprising the step of administering the composition.
[The present invention 1003]
The composition for use of the present invention 1001 or 1002, wherein the second administration is administered within a period of at least 6 weeks and at most 3 months after the first administration, and/or the third administration is administered within a period of at least 5 months and at most 7 months after the first administration.
[The present invention 1004]
A composition for use according to any of the inventions 1001 to 1003, wherein the second administration is administered within a period of at least 50 days and at most 70 days, particularly at least 55 days and at most 60 days, especially 56 days, after the first administration; and/or the third administration is administered within a period of at least 170 days and at most 190 days, particularly at least 175 days and at most 185 days, especially 180 days, after the first administration.
[The present invention 1005]
A composition for use according to any of claims 1001 to 1004, wherein the fourth administration of the composition is administered at a period of at least 15 months and at most 21 months, particularly at least 17 months and at most 19 months, more particularly 18 months, after the first administration.
[The present invention 1006]
A composition for use according to any of claims 1001 to 1005, wherein the total protein content of the three said fusion proteins is within the range of 135μg to 180μg per dose for a human adult or child, in particular 135μg or 180μg per dose, or the total protein content of the three said fusion proteins is within the range of 67.5μg to 90μg per dose for a young child, in particular 67.5μg or 90μg per dose.
[The present invention 1007]
The composition for use according to any of claims 1001 to 1006, wherein said three fusion proteins constitute at least 60%, preferably at least 70%, more preferably at least 80% of all proteins in said composition.
[The present invention 1008]
A composition for use according to any one of claims 1001 to 1007, comprising the fusion proteins in a weight ratio of 1:1:1 (Lip-S1D1-S2D1: Lip-S4D1-S3hybD1: Lip-S5D1-S6D1).
[The present invention 1009]
A composition for use according to any of claims 1001 to 1008, comprising an adjuvant.
[The present invention 1010]
A composition for use according to any of claims 1001 to 1009 comprising an aluminum adjuvant, preferably an aluminum adjuvant having a low copper content, preferably an aluminum adjuvant having less than 1.25 ppb copper.
[The present invention 1011]
A composition for use according to any of claims 1001 to 1010, wherein the total protein content of the three fusion proteins is 135 μg per dose for a human adult or child, the second administration is 56 days after the first administration, the third administration is 180 days after the first administration, and an optional fourth administration is 18 months after the first administration.
[The present invention 1012]
A composition for use according to any of claims 1001 to 1010, wherein the total protein content of the three fusion proteins is 67.5 μg per dose for young children, the second administration is 56 days after the first administration, the third administration is 180 days after the first administration, and an optional fourth administration is 18 months after the first administration.
[The present invention 1013]
A composition for use according to any of claims 1001 to 1010, wherein the total protein content of the three fusion proteins is 180 μg per dose for a human adult or child, the second administration is 56 days after the first administration, the third administration is 180 days after the first administration, and an optional fourth administration is 18 months after the first administration.
[The present invention 1014]
A composition for use according to any of claims 1001 to 1010, wherein the total protein content of the three fusion proteins is 90 μg per dose for young children, the second administration is 56 days after the first administration, the third administration is 180 days after the first administration, and an optional fourth administration is 18 months after the first administration.
[The present invention 1015]
A composition for use according to any of claims 1001 to 1010, wherein the total protein content of the three fusion proteins is 135 μg per dose for a human adult or child, the second administration is 2 months after the first administration, the third administration is 6 months after the first administration, and an optional fourth administration is 18 months after the first administration.
[The present invention 1016]
The composition for use according to any of claims 1001 to 1010, wherein the total protein content of the three fusion proteins is 67.5 μg per dose for young children, the second administration is 2 months after the first administration, the third administration is 6 months after the first administration, and the optional fourth administration is 18 months after the first administration.
[The present invention 1017]
The composition for use according to any of claims 1001 to 1010, wherein the total protein content of the three said fusion proteins is 180 μg per dose for a human adult or child, the second administration is 2 months after the first administration, the third administration is 6 months after the first administration, and the optional fourth administration is 18 months after the first administration.
[The present invention 1018]
The composition for use according to any of claims 1001 to 1010, wherein the total protein content of the three fusion proteins is 90 μg per dose for young children, the second administration is 2 months after the first administration, the third administration is 6 months after the first administration, and the optional fourth administration is 18 months after the first administration.
[The present invention 1019]
The composition for use of any of claims 1001 to 1018, wherein the further administration is annually after the third administration, in particular 1 year, 2 years and 3 years later.
[The present invention 1020]
A composition for use according to any of claims 1001 to 1019, wherein the immune response elicited comprises an anti-OspA serotype 1, anti-OspA serotype 2, anti-OspA serotype 3, anti-OspA serotype 4, anti-OspA serotype 5, and/or anti-OspA serotype 6 antibody response having bactericidal activity.
[The present invention 1021]
The composition for use according to any of claims 1001 to 1020, wherein the immune response elicited comprises antibodies against Borrelia serotypes 1, 2, 3, 4, 5, and 6.
[The present invention 1022]
The composition for use according to any of claims 1001 to 1021, wherein said immune response against Borrelia serotypes 1, 2, 3, 4, 5, and 6 is sustained for at least about 60 days, at least about 180 days, at least about 365 days, or at least about 540 days.
[The present invention 1023]
A composition for use according to any of claims 1001 to 1022, comprising less than 1.25 ppb copper or a sufficient amount of L-methionine.
[The present invention 1024]
A composition for use according to any of claims 1001 to 1023, wherein the copper is in ionic form, particularly as Cu + or Cu2 + .
[The present invention 1025]
The composition for use according to any of claims 1001 to 1024, wherein L-methionine is present in a concentration of at least 10 mmol/l.
[The present invention 1026]
6. The composition for use according to any of claims 1023 to 1025, wherein the concentration of L-methionine in mol/l is at least equivalent to the concentration of copper in said composition.
[The present invention 1027]
A composition for use according to any of claims 1001 to 1026, further comprising a reactive compound, said reactive compound being selected from the group consisting of redox active compounds, radical building compounds, stabilizing compounds, and any combination thereof, in particular said reactive compound being selected from the group consisting of formaldehyde, ethanol, chloroform, trichloroethylene, acetone, triton-X-100, deoxycholate, diethylpyrocarbonate, sulfite, Na2S2O5, beta - proprio - lactone , polysorbates such as Tween 20 (registered trademark), Tween 80 (registered trademark), O2 , phenol, pluronic type copolymers, and any combination thereof.
[The present invention 1028]
The composition for use according to any of claims 1001 to 1027, wherein said human adult is a subject aged 18 years or older, for example aged 18 to 65 years.
[The present invention 1029]
The composition for use according to any of claims 1001 to 1027, wherein said human adult is an elderly subject, 50 years of age or older.
[The present invention 1030]
The composition for use according to any of claims 1001 to 1027, wherein said human child is a subject aged between 5 and 17 years, such as between 12 and 17 years or between 5 and 11 years.
[The present invention 1031]
The composition for use according to any of claims 1001-1027, wherein said human child is a subject aged 0-4 years, such as 1-4 years or 2-4 years.
[The present invention 1032]
The composition for use according to any of claims 1001-1031 to be administered to a human adult or child in a volume of between 0.25 milliliters (ml) and 1.0 ml, for example 0.25 ml, 0.3 ml, 0.4 ml, 0.5 ml, 0.6 ml, 0.7 ml, 0.8 ml, 0.9 ml, or 1.0 ml.
[The present invention 1033]
A composition for use according to any of claims 1001-1032, administered to a human adult or child in a volume of 0.25 ml, 0.5 ml, or 1.0 ml.
[The present invention 1034]
1. A composition for use in vaccinating a human, comprising:
The method comprises administering to a subject a composition comprising a fusion protein of SEQ ID NO: 1 (Lip-S1D1-S2D1), a fusion protein of SEQ ID NO: 2 (Lip-S4D1-S3hybD1), and a fusion protein of SEQ ID NO: 3 (Lip-S5D1-S6D1),
- at least twice to a human adult or a human child, with a total protein content of the three fusion proteins in the range of 120-200 μg per dose; or
- at least twice to a human child, with a total protein content of the three fusion proteins in the range of 60-100 μg per dose;
The composition comprising the step of administering.
[The present invention 1035]
1. A composition for use in eliciting an immune response in a human against Lyme disease, comprising:
The method comprises administering to a subject a composition comprising a fusion protein of SEQ ID NO: 1 (Lip-S1D1-S2D1), a fusion protein of SEQ ID NO: 2 (Lip-S4D1-S3hybD1), and a fusion protein of SEQ ID NO: 3 (Lip-S5D1-S6D1),
- at least twice to a human adult or a human child, with a total protein content of the three fusion proteins in the range of 120-200 μg per dose; or
- at least twice to a human child, with a total protein content of the three fusion proteins in the range of 60-100 μg per dose;
The composition comprising the step of administering.
[The present invention 1036]
The composition of the present invention 1034 or the use of the present invention 1035, wherein the second administration is within a period of at least 5 months and up to 7 months after the first administration.
[The present invention 1037]
The composition for use according to any of claims 1034 to 1036, wherein the second administration is administered during a period of at least 170 days and at most 190 days, at least 175 days and at most 185 days, in particular 180 days, after the first administration.
[The present invention 1038]
The composition for use according to any of claims 1034 to 1037, wherein the third administration of the composition is administered at a period of at least 15 months and at most 21 months, particularly at least 17 months and at most 19 months, more particularly 18 months, after the first administration.
[The present invention 1039]
A composition for use according to any of claims 1034 to 1038, wherein the total protein content of the three said fusion proteins is within the range of 135μg to 180μg per dose for a human adult or child, in particular 135μg or 180μg per dose, or the total protein content of the three said fusion proteins is within the range of 67.5μg to 90μg per dose for a young child, in particular 67.5μg or 90μg per dose.
[The present invention 1040]
The composition for use according to any of claims 1034 to 1039, wherein the three fusion proteins constitute at least 60%, preferably at least 70%, more preferably at least 80% of all proteins in said composition.
[The present invention 1041]
A composition for use according to any one of claims 1034 to 1040, comprising the fusion proteins in a weight ratio of 1:1:1 (Lip-S1D1-S2D1: Lip-S4D1-S3hybD1: Lip-S5D1-S6D1).
[The present invention 1042]
A composition for use according to any one of claims 1034 to 1041, comprising an adjuvant.
[The present invention 1043]
A composition for use according to any one of claims 1034 to 1042, comprising an aluminum adjuvant.
[The present invention 1044]
A composition for use according to any of claims 1034 to 1043, wherein the total protein content of the three said fusion proteins is 135 μg per dose for a human adult or child, the second administration being 180 days after the first administration, and an optional third administration being 18 months after the first administration, and optionally every 12 months thereafter.
[The present invention 1045]
A composition for use according to any of claims 1034 to 1043, wherein the total protein content of the three said fusion proteins is 67.5 μg per dose for young children, the second administration being 180 days after the first administration, and an optional third administration being 18 months after the first administration, and optionally every 12 months thereafter.
[The present invention 1046]
A composition for use according to any of claims 1034 to 1043, wherein the total protein content of the three said fusion proteins is 180 μg per dose for a human adult or child, the second administration being 180 days after the first administration, and an optional third administration being 18 months after the first administration, and optionally every 12 months thereafter.
[The present invention 1047]
A composition for use according to any of claims 1034 to 1043, wherein the total protein content of the three said fusion proteins is 90 μg per dose for young children, the second administration being 180 days after the first administration, and an optional third administration being 18 months after the first administration, and optionally every 12 months thereafter.
[The present invention 1048]
A composition for use according to any of claims 1034 to 1043, wherein the total protein content of the three said fusion proteins is 135 μg per dose for a human adult or child, the second administration being 6 months after the first administration, and an optional third administration being 18 months after the first administration, and optionally every 12 months thereafter.
[The present invention 1049]
A composition for use according to any of claims 1034 to 1043, wherein the total protein content of the three said fusion proteins is 67.5 μg per dose for young children, the second administration being 6 months after the first administration, and an optional third administration being 18 months after the first administration, and optionally every 12 months thereafter.
[The present invention 1050]
A composition for use according to any of claims 1034 to 1043, wherein the total protein content of the three said fusion proteins is 180 μg per dose for a human adult or child, the second administration being 6 months after the first administration, and an optional third administration being 18 months after the first administration, and optionally every 12 months thereafter.
[The present invention 1051]
The composition for use according to any of claims 1034 to 1043, wherein the total protein content of the three said fusion proteins is 90 μg per dose for young children, the second administration being 6 months after the first administration, and the optional third administration being 18 months after the first administration, and optionally every 12 months thereafter.
[The present invention 1052]
A composition for use according to any of claims 1034 to 1051, wherein the further administration is annually after the last primary immunization or at the beginning of each tick season, in particular after 1 year, 2 years and 3 years etc.
[The present invention 1053]
A composition for use according to any of claims 1034 to 1052, wherein the immune response elicited comprises an anti-OspA serotype 1, anti-OspA serotype 2, anti-OspA serotype 3, anti-OspA serotype 4, anti-OspA serotype 5, and/or anti-OspA serotype 6 antibody response having bactericidal activity.
[The present invention 1054]
A composition for use according to any of claims 1034 to 1053, wherein said immune response elicited comprises antibodies having bactericidal activity against spirochetes expressing OspA serotypes 1, 2, 3, 4, 5 and 6.
[The present invention 1055]
A composition for use according to any of claims 1034 to 1054, wherein said immune response against OspA serotypes 1, 2, 3, 4, 5 and 6 is sustained for at least about 60 days, at least about 180 days, at least about 365 days, or at least about 540 days.
[The present invention 1056]
A composition for use according to any of claims 1034 to 1055, comprising less than 1.25 ppb copper or a sufficient amount of L-methionine.
[The present invention 1057]
The composition for use according to any of claims 1034 to 1056, wherein the copper is in ionic form, particularly as Cu + or Cu2 + .
[The present invention 1058]
The composition for use according to any of claims 1034 to 1057, wherein L-methionine is present in a concentration of at least 10 mmol/l.
[The present invention 1059]
The composition for use according to any of claims 1056 to 1058, wherein the concentration in mol/l of L-methionine is at least equivalent to the concentration of copper in said composition.
[The present invention 1060]
A composition for use according to any of claims 1034 to 1059, further comprising a reactive compound, said reactive compound being selected from the group consisting of redox active compounds, radical forming compounds, stabilizing compounds, and any combination thereof, in particular said reactive compound being selected from the group consisting of formaldehyde, ethanol, chloroform, trichloroethylene, acetone, triton-X-100, deoxycholate, diethylpyrocarbonate, sulfite, Na2S2O5 , β - proprio - lactone, polysorbates such as Tween 20 (registered trademark), Tween 80 (registered trademark), O2 , phenol, pluronic type copolymers, and any combination thereof.
[The present invention 1061]
The composition for use according to any of claims 1034 to 1060, wherein said human adult is a subject aged 18 years or older, for example aged 18 to 65 years.
[The present invention 1062]
The composition for use according to any of claims 1034 to 1060, wherein said human adult is an elderly subject, 50 years of age or older.
[The present invention 1063]
The composition for use according to any of claims 1034 to 1060, wherein said human child is a subject aged between 5 and 17 years, such as between 12 and 17 years or between 5 and 11 years.
[The present invention 1064]
The composition for use according to any of claims 1034 to 1060, wherein said human child is a subject aged 0 to 4 years, such as 1 to 4 years or 2 to 4 years.
[The present invention 1065]
A composition for use according to any of claims 1034-1064 to be administered to a human adult or child in a volume of between 0.25 milliliters (ml) and 1.0 ml, for example 0.25 ml, 0.3 ml, 0.4 ml, 0.5 ml, 0.6 ml, 0.7 ml, 0.8 ml, 0.9 ml, or 1.0 ml.
[The present invention 1066]
A composition for use according to any of claims 1034-1065, administered to a human adult or child in a volume of 0.25 ml, 0.5 ml, or 1.0 ml.
Claims (22)
前記方法が、
- ヒト成人もしくはヒト小児に少なくとも3回または少なくとも2回、用量当たり120～200μgの範囲内の、3つの前記融合タンパク質の総タンパク質含量で；または
- ヒト小児に少なくとも3回または少なくとも2回、用量当たり60～100μgの範囲内の、3つの前記融合タンパク質の総タンパク質含量で
前記組成物を投与する工程を含む、前記組成物。 A composition comprising a fusion protein of SEQ ID NO: 1 (Lip-S1D1-S2D1), a fusion protein of SEQ ID NO: 2 (Lip-S4D1-S3hybD1) and a fusion protein of SEQ ID NO: 3 (Lip-S5D1-S6D1) for use in a method for vaccinating a human, comprising:
The method ,
- at least three doses or at least two doses to a human adult or a human child, with a total protein content of the three fusion proteins in the range of 120-200 μg per dose; or
- at least three doses or at least two doses to a human child, with a total protein content of the three fusion proteins in the range of 60-100 μg per dose;
The composition comprising the step of administering the composition .
前記方法が、
- ヒト成人もしくはヒト小児に少なくとも3回または少なくとも2回、用量当たり120～200μgの範囲内の、3つの前記融合タンパク質の総タンパク質含量で；または
- ヒト小児に少なくとも3回または少なくとも2回、用量当たり60～100μgの範囲内の、3つの前記融合タンパク質の総タンパク質含量で
前記組成物を投与する工程を含む、前記組成物。 1. A composition comprising a fusion protein of SEQ ID NO: 1 (Lip-S1D1-S2D1), a fusion protein of SEQ ID NO: 2 (Lip-S4D1-S3hybD1) and a fusion protein of SEQ ID NO: 3 (Lip-S5D1-S6D1) for use in a method for raising an immune response in a human against Lyme disease, the composition comprising:
The method,
- at least three doses or at least two doses to a human adult or a human child, with a total protein content of the three fusion proteins in the range of 120-200 μg per dose; or
- administering said composition to a human child at least three times or at least two times , with a total protein content of three of said fusion proteins in the range of 60-100 μg per dose.
2回目の投与が、1回目の投与後少なくとも6週から多くても3ヶ月までの期間中であり、かつ/または3回目の投与が、1回目の投与後少なくとも5ヶ月から多くても7ヶ月までの期間中であるか、または
2回目の投与が、1回目の投与後、少なくとも50日から多くても70日までの期間中、特に少なくとも55日から多くても60日までの期間中、とりわけ56日であり；かつ/または3回目の投与が、1回目の投与後、少なくとも170日から多くても190日までの期間中、少なくとも175日から多くても185日までの期間中、とりわけ180日である、
請求項1または2記載の使用のための組成物。 The composition is administered at least three times;
the second dose is administered at least 6 weeks and up to 3 months after the first dose, and/or the third dose is administered at least 5 months and up to 7 months after the first dose , or
the second administration is administered within a period of at least 50 days and at most 70 days, particularly at least 55 days and at most 60 days, especially 56 days, after the first administration; and/or the third administration is administered within a period of at least 170 days and at most 190 days, particularly at least 175 days and at most 185 days, especially 180 days, after the first administration.
3. A composition for use according to claim 1 or 2.
前記組成物の4回目の投与が、1回目の投与後、少なくとも15ヶ月から多くても21ヶ月までの期間中、特に少なくとも17ヶ月から多くても19ヶ月までの期間中、とりわけ18ヶ月である、請求項1～3のいずれか一項記載の使用のための組成物。 The composition is administered at least three times;
The composition for use according to any one of claims 1 to 3, wherein the fourth administration of the composition is administered at a period of at least 15 months and at most 21 months, in particular at least 17 months and at most 19 months, especially 18 months, after the first administration.
2回目の投与が、1回目の投与後少なくとも5ヶ月から多くても7ヶ月までの期間中であるか、またはThe second dose is administered at least 5 months but not more than 7 months after the first dose, or
2回目の投与が、1回目の投与後、少なくとも170日から多くても190日までの期間中、少なくとも175日から多くても185日までの期間中、とりわけ180日である、The second dose is administered within a period of at least 170 days and at most 190 days, at least 175 days and at most 185 days, especially 180 days, after the first dose;
請求項1～4のいずれか一項記載の使用のための組成物。A composition for use according to any one of claims 1 to 4.
前記組成物の3回目の投与が、1回目の投与後、少なくとも15ヶ月から多くても21ヶ月までの期間中、特に少なくとも17ヶ月から多くても19ヶ月までの期間中、とりわけ18ヶ月である、The third administration of the composition is administered at a time period of at least 15 months and at most 21 months, particularly at least 17 months and at most 19 months, more particularly 18 months, after the first administration.
請求項1～5のいずれか一項記載の使用のための組成物。A composition for use according to any one of claims 1 to 5.
3つの前記融合タンパク質の総タンパク質含量が、ヒト成人または小児に対して用量当たり135μgであり、2回目の投与が、1回目の投与の56日後であり、3回目の投与が、1回目の投与の180日後であり、かつ任意の4回目の投与が、1回目の投与の18ヶ月後であるか、または
3つの前記融合タンパク質の総タンパク質含量が、幼い小児に対して用量当たり67.5μgまたは90μgであり、2回目の投与が、1回目の投与の56日後であり、3回目の投与が、1回目の投与の180日後であり、かつ任意の4回目の投与が、1回目の投与の18ヶ月後である、
請求項1～10のいずれか一項記載の使用のための組成物。 The composition is administered at least three times;
the total protein content of the three fusion proteins is 135 μg per dose for a human adult or child, the second administration is 56 days after the first administration, the third administration is 180 days after the first administration, and an optional fourth administration is 18 months after the first administration ; or
the total protein content of the three fusion proteins is 67.5 μg or 90 μg per dose for young children, the second dose is 56 days after the first dose, the third dose is 180 days after the first dose, and an optional fourth dose is 18 months after the first dose;
A composition for use according to any one of claims 1 to 10.
3つの前記融合タンパク質の総タンパク質含量が、ヒト成人または小児に対して用量当たり135μgまたは180μgであり、2回目の投与が、1回目の投与の2ヶ月後であり、3回目の投与が、1回目の投与の6ヶ月後であり、かつ任意の4回目の投与が、1回目の投与の18ヶ月後であるか、または
3つの前記融合タンパク質の総タンパク質含量が、幼い小児に対して用量当たり67.5μgまたは90μgであり、2回目の投与が、1回目の投与の2ヶ月後であり、3回目の投与が、1回目の投与の6ヶ月後であり、かつ任意の4回目の投与が、1回目の投与の18ヶ月後である、
請求項1～10のいずれか一項記載の使用のための組成物。 The composition is administered at least three times;
the total protein content of the three fusion proteins is 135 μg or 180 μg per dose for a human adult or child, the second administration is 2 months after the first administration, the third administration is 6 months after the first administration, and an optional fourth administration is 18 months after the first administration ; or
the total protein content of the three fusion proteins is 67.5 μg or 90 μg per dose for young children, the second administration is 2 months after the first administration, the third administration is 6 months after the first administration, and an optional fourth administration is 18 months after the first administration;
A composition for use according to any one of claims 1 to 10.
3つの前記融合タンパク質の総タンパク質含量が、ヒト成人または小児に対して用量当たり135μgまたは180μgであり、2回目の投与が、1回目の投与の180日後であり、かつ任意の3回目の投与が、1回目の投与の18ヶ月後であり、および任意でその後12ヶ月毎であり、または
3つの前記融合タンパク質の総タンパク質含量が、幼い小児に対して用量当たり67.5μgまたは90μgであり、2回目の投与が、1回目の投与の180日後であり、かつ任意の3回目の投与が、1回目の投与の18ヶ月後であり、および任意でその後12ヶ月毎である、
請求項1～12のいずれか一項記載の使用のための組成物。 The composition is administered at least twice,
the total protein content of the three fusion proteins is 135 μg or 180 μg per dose for a human adult or child, the second administration is 180 days after the first administration, and an optional third administration is 18 months after the first administration, and optionally every 12 months thereafter; or
the total protein content of the three fusion proteins is 67.5 μg or 90 μg per dose for young children, the second dose is 180 days after the first dose, and the optional third dose is 18 months after the first dose, and optionally every 12 months thereafter;
A composition for use according to any one of claims 1 to 12 .
3つの前記融合タンパク質の総タンパク質含量が、ヒト成人または小児に対して用量当たり135μgまたは180μgであり、2回目の投与が、1回目の投与の6ヶ月後であり、かつ任意の3回目の投与が、1回目の投与の18ヶ月後であり、および任意でその後12ヶ月毎であり、またはthe total protein content of the three fusion proteins is 135 μg or 180 μg per dose for a human adult or child, the second administration being 6 months after the first administration, and an optional third administration being 18 months after the first administration, and optionally every 12 months thereafter; or
3つの前記融合タンパク質の総タンパク質含量が、幼い小児に対して用量当たり67.5μgまたは90μgであり、2回目の投与が、1回目の投与の6ヶ月後であり、かつ任意の3回目の投与が、1回目の投与の18ヶ月後であり、および任意でその後12ヶ月毎である、the total protein content of the three fusion proteins is 67.5 μg or 90 μg per dose for young children, the second administration is 6 months after the first administration, and the optional third administration is 18 months after the first administration, and optionally every 12 months thereafter;
請求項1～13のいずれか一項記載の使用のための組成物。A composition for use according to any one of claims 1 to 13.
Applications Claiming Priority (13)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP20169147 | 2020-04-09 | ||
| EP20169148.2 | 2020-04-09 | ||
| EP20169148 | 2020-04-09 | ||
| EP20169147.4 | 2020-04-09 | ||
| EP20169642 | 2020-04-15 | ||
| EP20169642.4 | 2020-04-15 | ||
| EP20187283.5 | 2020-07-22 | ||
| EP20187283 | 2020-07-22 | ||
| EP20202816 | 2020-10-20 | ||
| EP20202816.3 | 2020-10-20 | ||
| US202163152582P | 2021-02-23 | 2021-02-23 | |
| US63/152,582 | 2021-02-23 | ||
| PCT/US2021/026599 WO2021207615A1 (en) | 2020-04-09 | 2021-04-09 | Compositions comprising three ospa fusion proteins for medical use |
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| JP2023522170A JP2023522170A (en) | 2023-05-29 |
| JPWO2021207615A5 true JPWO2021207615A5 (en) | 2024-04-11 |
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| JP2022561414A Pending JP2023522170A (en) | 2020-04-09 | 2021-04-09 | Compositions containing three OspA fusion proteins for medical use |
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| US (1) | US20230173051A1 (en) |
| EP (1) | EP4132950A1 (en) |
| JP (1) | JP2023522170A (en) |
| KR (1) | KR20220167305A (en) |
| CN (1) | CN115698044A (en) |
| AU (1) | AU2021254265A1 (en) |
| BR (1) | BR112022020438A2 (en) |
| CA (1) | CA3174892A1 (en) |
| IL (1) | IL297166A (en) |
| MX (1) | MX2022012647A (en) |
| WO (1) | WO2021207615A1 (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CA3059817A1 (en) | 2017-04-13 | 2018-10-18 | Valneva Austria Gmbh | Multivalent ospa polypeptides and methods and uses relating thereto |
| WO2023212520A1 (en) | 2022-04-25 | 2023-11-02 | Pfizer Inc. | Compositions and methods for eliciting an immune response protective against lyme disease |
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| US8986704B2 (en) | 2012-07-06 | 2015-03-24 | Valneva Austria Gmbh | Mutant fragments of OspA and methods and uses relating thereto |
| JP6505110B2 (en) | 2014-01-09 | 2019-04-24 | バルネバ オーストリア ゲーエムベーハ— | Mutant fragments of OspA and methods and uses relating thereto |
| CA3059817A1 (en) * | 2017-04-13 | 2018-10-18 | Valneva Austria Gmbh | Multivalent ospa polypeptides and methods and uses relating thereto |
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- 2021-04-09 AU AU2021254265A patent/AU2021254265A1/en active Pending
- 2021-04-09 KR KR1020227039114A patent/KR20220167305A/en active Search and Examination
- 2021-04-09 BR BR112022020438A patent/BR112022020438A2/en unknown
- 2021-04-09 WO PCT/US2021/026599 patent/WO2021207615A1/en active Application Filing
- 2021-04-09 EP EP21720149.0A patent/EP4132950A1/en active Pending
- 2021-04-09 JP JP2022561414A patent/JP2023522170A/en active Pending
- 2021-04-09 US US17/917,624 patent/US20230173051A1/en active Pending
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