HRP20180216T1 - Fuzijski proteini i kombinacijska cjepiva koja sadrže protein e i pilin a iz bakterije haemophilus influenzae - Google Patents

Fuzijski proteini i kombinacijska cjepiva koja sadrže protein e i pilin a iz bakterije haemophilus influenzae Download PDF

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HRP20180216T1
HRP20180216T1 HRP20180216TT HRP20180216T HRP20180216T1 HR P20180216 T1 HRP20180216 T1 HR P20180216T1 HR P20180216T T HRP20180216T T HR P20180216TT HR P20180216 T HRP20180216 T HR P20180216T HR P20180216 T1 HRP20180216 T1 HR P20180216T1
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fusion protein
protein according
amino acids
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Normand Blais
Steve Labbe
Jan Poolman
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Glaxosmithkline Biologicals S.A.
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Claims (24)

1. Fuzijski protein formule I: (X)m-(R1)n-A-(Y)o-B-(Z)- (formula I) naznačen time što: X je signalni peptid ili MHHHHHH (SEQ ID NO. 2); m je 0 ili 1; R1 je aminokiselina; n je 0, 1, 2, 3, 4, 5 ili 6; A je imunogeni fragment Proteina E koji se bira između SEQ ID NO. 122, SEQ ID NO. 123, SEQ ID NO. 124, SEQ ID NO. 125, SEQ ID NO. 126, SEQ ID NO. 179 ili SEQ ID NO. 180 ili slijed koji je najmanje 95% istovjetan bilo kojem od sljedova SEQ ID NO. 122, SEQ ID NO. 123, SEQ ID NO. 124, SEQ ID NO. 125, SEQ ID NO. 126, SEQ ID NO. 179 ili SEQ ID NO.180; Y se bira iz skupine koju čine GG, SG, SS, GGG i (G)h, gdje je h 4, 5, 6, 7, 8, 9 ili 10; o je 0 ili 1; B je imunogeni fragment PilA, najmanje 95% istovjetan aminokiselinama 40-149 iz bilo kojeg od SEQ ID NO. 58 do SEQ ID NO. 121; Z je GGHHHHHH (SEQ ID NO. 3); i p je 0 ili 1.
2. Fuzijski protein u skladu s patentnim zahtjevom 1, naznačen time što je X signalni peptid iz proteina koji se bira iz skupine koju čine Flgl, NadA i pelB.
3. Fuzijski protein u skladu s patentnim zahtjevom 1, naznačen time što je m 0.
4. Fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-3, naznačen time što je A imunogeni fragment Proteina E iz bakterije H. influenzae, koji se bira iz skupine koju čine aminokiseline 17-160 iz SEQ ID NO. 4 (SEQ ID NO. 122), aminokiseline 18-160 iz SEQ ID NO. 4 (SEQ ID NO. 123), aminokiseline 19-160 iz SEQ ID NO. 4 (SEQ ID NO. 124), aminokiseline 20-160 iz SEQ ID NO. 4 (SEQ ID NO. 125), aminokiseline 22-160 iz SEQ ID NO. 4 (SEQ ID NO. 126), aminokiseline 23-160 iz SEQ ID NO. 4 (SEQ ID NO. 179) i aminokiseline 24-160 iz SEQ ID NO. 4 (SEQ ID NO. 180).
5. Fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-4, naznačen time što je B imunogeni fragment PilA koju čine aminokiseline 40-149 iz bilo kojeg od SEQ ID NO. 58-SEQ ID NO. 121.
6. Fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-5, naznačen time što je B imunogeni fragment PilA iz bakterije H. influenzae, kao što je iznijeto u SEQ ID NO. 127.
7. Fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-6, naznačen time što je A SEQ ID NO. 125.
8. Fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-6, naznačen time što je A SEQ ID NO. 124.
9. Fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-4, naznačen time što je B fragment PilA, kao što je iznijeto u SEQ ID NO. 127, a A je imunogeni fragment Proteina E, koji se bira iz skupine koju čine SEQ ID NO. 122, SEQ ID NO. 124, SEQ ID NO. 125 i SEQ ID NO. 126.
10. Fuzijski protein u skladu s patentnim zahtjevom 1, naznačen time što se bira iz skupine koju čine SEQ ID NO. 138, SEQ ID NO. 140, SEQ ID NO. 142, SEQ ID NO. 144, SEQ ID NO. 146, SEQ ID NO. 148, SEQ ID NO. 150, SEQ ID NO. 182, SEQ ID NO. 184, SEQ ID NO. 186, SEQ ID NO. 188, SEQ ID NO. 190, SEQ ID NO. 192, SEQ ID NO. 194, SEQ ID NO. 196, SEQ ID NO. 198, SEQ ID NO. 200, SEQ ID NO. 202 ili SEQ ID NO. 204.
11. Fuzijski protein u skladu s patentnim zahtjevom 1, naznačen time što se bira iz skupine koju čine SEQ ID NO. 138, SEQ ID NO. 140, SEQ ID NO. 142, SEQ ID NO. 144, SEQ ID NO. 146, SEQ ID NO. 148, SEQ ID NO. 150, SEQ ID NO. 182, SEQ ID NO. 184, SEQ ID NO. 186, SEQ ID NO. 188, SEQ ID NO. 190, SEQ ID NO. 192, SEQ ID NO. 194, SEQ ID NO. 196, SEQ ID NO. 198, SEQ ID NO. 200, SEQ ID NO. 202 ili SEQ ID NO. 204, gdje je signalni peptid uklonjen.
12. Fuzijski protein u skladu s patentnim zahtjevom 1, naznačen time što ima SEQ ID NO. 148.
13. Fuzijski protein u skladu s patentnim zahtjevom 1, naznačen time što ima SEQ ID NO. 177 (QIQKAEQN DVKLAPPTDV RSGYIRLVKN VNYYIDSESI WVDNQEPQIV HFDAVVNLDK GLYVYPEPKR YARSVRQYKI LNCANYHLTQ VRTDFYDEFW GQGLRAAPKK QKKHTLSLTP DTTLYNAAQI ICANYGEAFS VDKKGGTKKA AVSELLQASA PYKADVELCV YSTNETTNCT GGKNGIAADI TTAKGYVKSV TTSNGAITVK GDGTLANMEY ILQATGNAAT GVTWTTTCKG TDASLFPANF CGSVTQ).
14. Fuzijski protein u skladu s patentnim zahtjevom 1, naznačen time što ima SEQ ID NO. 194.
15. Fuzijski protein u skladu s patentnim zahtjevom 1, naznačen time što ima SEQ ID NO. 219 (IQKAEQND VKLAPPTDVR SGYIRLVKNV NYYIDSESIW VDNQEPQIVH FDAVVNLDKG LYVYPEPKRY ARSVRQYKIL NCANYHLTQV RTDFYDEFWG QGLRAAPKKQ KKHTLSLTPD TTLYNAAQII CANYGEAFSV DKKGGTKKAA VSELLQASAP YKADVELCVY STNETTNCTG GKNGIAADIT TAKGYVKSVT TSNGAITVKG DGTLANMEYI LQATGNAATG VTWTTTCKGT DASLFPANFC GSVTQ).
16. Imunogeni pripravak, naznačen time što sadrži fuzijski proteini u skladu s bilo kojim od patentnih zahtjeva 1-15.
17. Imunogeni pripravak u skladu s patentnim zahtjevom 16, naznačen time što dodatno sadrži Protein D iz bakterije H. influenzae.
18. Imunogeni pripravak u skladu s patentnim zahtjevom 16 ili patentnim zahtjevom 17, naznačen time što dodatno sadrži adjuvans, gdje adjuvans može biti AS01, primjerice AS01B ili AS01E.
19. Cjepivo, naznačeno time što sadrži fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-15 ili imunogeni pripravak u skladu s patentnim zahtjevima 16-18.
20. Fuzijski protein u skladu s patentnim zahtjevima 1-15, ili imunogeni pripravak u skladu s patentnim zahtjevima 16-18, ili cjepivo u skladu s patentnim zahtjevom 19, naznačeni time što su namijenjeni upotrebi u liječenju ili sprječavanju upale srednjeg uha.
21. Fuzijski protein, imunogeni pripravak, ili cjepivo u skladu s patentnim zahtjevima 1-19, naznačeni time što su – namijenjeni upotrebi u liječenju ili sprječavanju akutnih egzacerbacija kronične opstruktivne plućne bolesti (AE-COPD); i/ili – namijenjeni upotrebi u liječenju ili sprječavanju pneumonije; i/ili – namijenjeni upotrebi u liječenju ili sprječavanju infekcije ili bolesti koje uzrokuje bakterija H. influenzae.
22. Fuzijski protein, imunogeni pripravak, ili cjepivo u skladu s patentnim zahtjevima 1-19, naznačeni time što su namijenjeni upotrebi u liječenju ili sprječavanju akutnih egzacerbacija kronične opstruktivne plućne bolesti (AE-COPD).
23. Fuzijski protein u skladu s patentnim zahtjevima 1-15, naznačen time što je namijenjen upotrebi u poticanju imunosnog odgovora protiv bakterije H. influenzae kod ljudi.
24. Postupak postizanja periplazmtske ekspresije fuzijskog proteina u skladu s patentnim zahtjevima 1-15, naznačen time što se postupak sastoji u poticanju ekspresije proteina koji sadrže signalni peptid, gdje se signalni peptid bira između Flgl ili pelB.
HRP20180216TT 2011-04-13 2018-02-06 Fuzijski proteini i kombinacijska cjepiva koja sadrže protein e i pilin a iz bakterije haemophilus influenzae HRP20180216T1 (hr)

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US201161474779P 2011-04-13 2011-04-13
US201161534012P 2011-09-13 2011-09-13
PCT/CA2012/050236 WO2012139225A1 (en) 2011-04-13 2012-04-12 Fusion proteins and combination vaccines comprising haemophilus influenzae protein e and pilin a
EP12771540.7A EP2707393B1 (en) 2011-04-13 2012-04-12 Fusion proteins and combination vaccines comprising haemophilus influenzae protein e and pilin a

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EP2908854A2 (en) * 2012-10-17 2015-08-26 GlaxoSmithKline Biologicals S.A. Immunogenic composition
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