HRP20160606T1 - Pripravak mikrobakterijskih antigena - Google Patents
Pripravak mikrobakterijskih antigena Download PDFInfo
- Publication number
- HRP20160606T1 HRP20160606T1 HRP20160606TT HRP20160606T HRP20160606T1 HR P20160606 T1 HRP20160606 T1 HR P20160606T1 HR P20160606T T HRP20160606T T HR P20160606TT HR P20160606 T HRP20160606 T HR P20160606T HR P20160606 T1 HRP20160606 T1 HR P20160606T1
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- Croatia
- Prior art keywords
- preparation according
- immunogenic preparation
- immunogenic
- less
- seq
- Prior art date
Links
- 241000186359 Mycobacterium Species 0.000 title 1
- 230000000890 antigenic effect Effects 0.000 title 1
- 230000002163 immunogen Effects 0.000 claims 26
- 239000000427 antigen Substances 0.000 claims 6
- 102000036639 antigens Human genes 0.000 claims 6
- 108091007433 antigens Proteins 0.000 claims 6
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 2
- 150000001413 amino acids Chemical class 0.000 claims 2
- 239000012634 fragment Substances 0.000 claims 2
- 229920005862 polyol Polymers 0.000 claims 2
- 150000003077 polyols Chemical class 0.000 claims 2
- 239000000600 sorbitol Substances 0.000 claims 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- 125000000539 amino acid group Chemical group 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 229960001438 immunostimulant agent Drugs 0.000 claims 1
- 239000003022 immunostimulating agent Substances 0.000 claims 1
- 230000003308 immunostimulating effect Effects 0.000 claims 1
- GZQKNULLWNGMCW-PWQABINMSA-N lipid A (E. coli) Chemical class O1[C@H](CO)[C@@H](OP(O)(O)=O)[C@H](OC(=O)C[C@@H](CCCCCCCCCCC)OC(=O)CCCCCCCCCCCCC)[C@@H](NC(=O)C[C@@H](CCCCCCCCCCC)OC(=O)CCCCCCCCCCC)[C@@H]1OC[C@@H]1[C@@H](O)[C@H](OC(=O)C[C@H](O)CCCCCCCCCCC)[C@@H](NC(=O)C[C@H](O)CCCCCCCCCCC)[C@@H](OP(O)(O)=O)O1 GZQKNULLWNGMCW-PWQABINMSA-N 0.000 claims 1
- 108090000623 proteins and genes Proteins 0.000 claims 1
- 102000004169 proteins and genes Human genes 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
- 239000012929 tonicity agent Substances 0.000 claims 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/02—Bacterial antigens
- A61K39/04—Mycobacterium, e.g. Mycobacterium tuberculosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
- A61P31/06—Antibacterial agents for tuberculosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
- G01N33/56911—Bacteria
- G01N33/5695—Mycobacteria
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
- A61K2039/55511—Organic adjuvants
- A61K2039/55555—Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
- A61K2039/55511—Organic adjuvants
- A61K2039/55572—Lipopolysaccharides; Lipid A; Monophosphoryl lipid A
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
- A61K2039/55511—Organic adjuvants
- A61K2039/55577—Saponins; Quil A; QS21; ISCOMS
Claims (24)
1. Imunogeni pripravak, naznačen time što sadrži antigen srodan Rv1196, gdje antigen srodan Rv1196 sadrži (a) slijed koji je najmanje 90% identičan SEQ ID No: 1 ili (b) fragment SEQ ID No: 1 dug najmanje 350 aminokiselina, te što je vodljivost pripravka 5 mS/cm ili manja, te gdje je pH navedenog pripravka je u rasponu od 7,0 do 9,0.
2. Imunogeni pripravak u skladu s patentnim zahtjevom 1, naznačen time što je vodljivost pripravka 4 mS/cm ili manja.
3. Imunogeni pripravak u skladu s patentnim zahtjevom 2, naznačen time što je vodljivost pripravka 3 mS/cm ili manja.
4. Imunogeni pripravak u skladu s patentnim zahtjevom 1, naznačen time što je koncentracija soli u navedenom pripravku 40 mM ili manja.
5. Imunogeni pripravak u skladu s patentnim zahtjevom 1, naznačen time što je koncentracija natrijevog klorida u navedenom pripravku 40 mM ili manja.
6. Imunogeni pripravak u skladu s patentnim zahtjevom bilo kojim od patentnih zahtjeva 1 do 5, naznačen time što dodatno sadrži neionsko sredstvo za toničnost koje je poliol.
7. Imunogeni pripravak u skladu s patentnim zahtjevom 6, naznačen time što je poliol sorbitol, te što koncentracija sorbitola je između otprilike 4 i otprilike 6% (tež./vol.).
8. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što koncentracija saharoze je između otprilike 4 i otprilike 6% (tež./vol.).
9. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačen time što dodatno sadrži jedan ili više imunostimulansa.
10. Imunogeni pripravak u skladu s patentnim zahtjevom 9, naznačen time što imunogeni pripravak sadrži QS21.
11. Imunogeni pripravak u skladu s bilo patentnim zahtjevom 9 ili patentnim zahtjevom 10, naznačen time što imunogeni pripravak sadrži 3-de-O-acilirani monofosforilirani lipid A.
12. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 11, naznačen time što je osmolalnost 250 do 750 mOsm/kg.
13. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 12, naznačen time što se pripravak osigurava kao jedinična doza koja se kreće između 50 µl i 1 ml.
14. Imunogeni pripravak u skladu s patentnim zahtjevom 13, naznačen time što jedinična doza sadrži 1 do 100 µg proteina srodnog Rv1196.
15. Imunogeni pripravak u skladu s patentnim zahtjevom 13 ili 14, naznačen time što je jedinična doza doza namijenjena za čovjeka i sadrži između 1 i 100 µg 3D-MPL.
16. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 13 do 15, naznačen time što je jedinična doza doza namijenjena za čovjeka i sadrži između 1 i 100 µg QS21.
17. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 16, naznačen time što je pH navedenog pripravka u rasponu od 7,25 do 8,75.
18. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 16, naznačen time što je pH navedenog pripravka u rasponu od 7,5 do 8,5.
19. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 18, naznačen time što antigen srodan Rv1196 sadrži slijed koji je najmanje 90% identičan SEQ ID No: 1.
20. Imunogeni pripravak u skladu s patentnim zahtjevom 19, naznačen time što antigen srodan Rv1196 sadrži SEQ ID No: 1.
21. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 18, naznačen time što antigen srodan Rv1196 sadrži fragment SEQ ID No: 1 dug najmanje 350 aminokiselina.
22. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 21, naznačen time što antigen srodan Rv1196 sadrži manje od 1000 aminokiselinskih ostataka.
23. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 22, naznačen time što je namijenjen upotrebi u medicini.
24. Imunogeni pripravak, namijenjen upotrebi u skladu s patentnim zahtjevom 23, naznačen time što je namijenjen primjeni na čovjeku.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US42272310P | 2010-12-14 | 2010-12-14 | |
| PCT/EP2011/072817 WO2012080370A1 (en) | 2010-12-14 | 2011-12-14 | Mycobacterium antigenic composition |
| EP11794778.8A EP2651436B1 (en) | 2010-12-14 | 2011-12-14 | Mycobacterium antigenic composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20160606T1 true HRP20160606T1 (hr) | 2016-07-01 |
Family
ID=45346501
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20160362TT HRP20160362T1 (hr) | 2010-12-14 | 2016-04-08 | Antigeni pripravak protiv bakterija iz roda mycobacterium |
| HRP20160606TT HRP20160606T1 (hr) | 2010-12-14 | 2016-06-06 | Pripravak mikrobakterijskih antigena |
| HRP20191843TT HRP20191843T1 (hr) | 2010-12-14 | 2019-10-11 | Mikobakterijski antigenski pripravak |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20160362TT HRP20160362T1 (hr) | 2010-12-14 | 2016-04-08 | Antigeni pripravak protiv bakterija iz roda mycobacterium |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20191843TT HRP20191843T1 (hr) | 2010-12-14 | 2019-10-11 | Mikobakterijski antigenski pripravak |
Country Status (32)
| Country | Link |
|---|---|
| US (5) | US9730992B2 (hr) |
| EP (4) | EP3593813A1 (hr) |
| JP (2) | JP5951634B2 (hr) |
| KR (3) | KR20140029376A (hr) |
| CN (4) | CN106822882A (hr) |
| AR (1) | AR084285A1 (hr) |
| AU (2) | AU2011343368C1 (hr) |
| BR (2) | BR112013014599A2 (hr) |
| CA (2) | CA2819298A1 (hr) |
| CO (2) | CO6751287A2 (hr) |
| CY (1) | CY1122187T1 (hr) |
| DK (3) | DK2651437T3 (hr) |
| EA (2) | EA027504B1 (hr) |
| ES (3) | ES2567190T3 (hr) |
| HR (3) | HRP20160362T1 (hr) |
| HU (3) | HUE045766T2 (hr) |
| IL (2) | IL226450A0 (hr) |
| LT (1) | LT3023106T (hr) |
| ME (1) | ME02380B (hr) |
| MX (2) | MX344280B (hr) |
| MY (1) | MY161412A (hr) |
| PL (3) | PL2651436T3 (hr) |
| PT (2) | PT2651436E (hr) |
| RS (1) | RS54687B1 (hr) |
| SG (2) | SG190731A1 (hr) |
| SI (3) | SI3023106T1 (hr) |
| SM (1) | SMT201600118B (hr) |
| TW (1) | TW201305192A (hr) |
| UA (2) | UA110806C2 (hr) |
| UY (1) | UY33802A (hr) |
| WO (2) | WO2012080369A1 (hr) |
| ZA (2) | ZA201304015B (hr) |
Families Citing this family (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP5164830B2 (ja) | 2005-04-29 | 2013-03-21 | グラクソスミスクライン バイオロジカルズ ソシエテ アノニム | 結核菌感染の予防または治療のための新規方法 |
| MY161412A (en) | 2010-12-14 | 2017-04-14 | Glaxosmithkline Biologicals Sa | Mycobacterium antigenic composition |
| HUE032409T2 (en) | 2011-01-04 | 2017-09-28 | Archivel Farma Sl | Liposome preparation for treating or preventing tuberculosis |
| PT2802345T (pt) | 2012-01-12 | 2018-04-24 | Archivel Farma Sl | Vacina mtb-c contra a asma |
| US9993427B2 (en) | 2013-03-14 | 2018-06-12 | Biorest Ltd. | Liposome formulation and manufacture |
| GB201405921D0 (en) * | 2014-04-02 | 2014-05-14 | Glaxosmithkline Biolog Sa | Novel methods for inducing an immune response |
| CN113046312A (zh) | 2014-04-23 | 2021-06-29 | 朱诺治疗学股份有限公司 | 分离、培养和遗传工程改造用于过继治疗的免疫细胞群的方法 |
| GB201513176D0 (en) | 2015-07-27 | 2015-09-09 | Glaxosmithkline Biolog Sa | Novel methods for inducing an immune response |
| GB201522068D0 (en) * | 2015-12-15 | 2016-01-27 | Glaxosmithkline Biolog Sa | Dried composition |
| JP7136777B2 (ja) | 2016-12-07 | 2022-09-13 | グラクソスミスクライン バイオロジカルズ ソシエテ アノニム | 新規プロセス |
| GB201621686D0 (en) | 2016-12-20 | 2017-02-01 | Glaxosmithkline Biologicals Sa | Novel methods for inducing an immune response |
| GB201707700D0 (en) | 2017-05-12 | 2017-06-28 | Glaxosmithkline Biologicals Sa | Dried composition |
| GB2600653B (en) | 2017-05-30 | 2022-11-02 | Glaxosmithkline Biologicals Sa | Novel methods |
| EP3717001A1 (en) | 2017-12-01 | 2020-10-07 | GlaxoSmithKline Biologicals S.A. | Saponin purification |
| RU2728976C2 (ru) * | 2018-03-22 | 2020-08-03 | Зули Холдингз, Лтд. | Липосомный состав и его получение |
| MX2021001129A (es) | 2018-07-31 | 2021-07-02 | Glaxosmithkline Biologicals Sa | Metodo de purificacion de antigenos. |
| US20220339282A1 (en) | 2018-11-29 | 2022-10-27 | Glaxosmithkline Biologicals Sa | Methods for manufacturing an adjuvant |
| BR112021024363A2 (pt) | 2019-06-05 | 2022-03-22 | Glaxosmithkline Biologicals Sa | Purificação de saponina |
| EP3777884A1 (en) | 2019-08-15 | 2021-02-17 | GlaxoSmithKline Biologicals S.A. | Immunogenic composition |
| US20210069321A1 (en) | 2019-09-09 | 2021-03-11 | Glaxosmithkline Biologicals Sa | Immunotherapeutic compositions |
| CA3161857A1 (en) | 2019-11-22 | 2021-05-27 | Glaxosmithkline Biologicals Sa | Dosage and administration of a bacterial saccharide glycoconjugate vaccine |
| MX2022013855A (es) | 2020-05-05 | 2022-11-30 | Glaxosmithkline Biologicals Sa | Dispositivos de mezcla de microfluidos y metodos de uso. |
| US20230234992A1 (en) | 2020-06-05 | 2023-07-27 | Glaxosmithkline Biologicals Sa | Modified betacoronavirus spike proteins |
| WO2022122830A2 (en) | 2020-12-09 | 2022-06-16 | Glaxosmithkline Biologicals Sa | Saponins |
| CN114034860A (zh) * | 2021-11-01 | 2022-02-11 | 宁夏大学 | 一种结核分枝杆菌mtb39a蛋白抗体间接elisa检测方法及其试剂盒 |
| WO2023242187A1 (en) | 2022-06-15 | 2023-12-21 | Glaxosmithkline Biologicals Sa | Enzymatic modification of saponins |
| CN116120411B (zh) * | 2022-12-07 | 2024-04-12 | 中国疾病预防控制中心传染病预防控制所 | 结核分枝杆菌蛋白抗原混合物、多抗原融合蛋白及编码基因和应用 |
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