HRP20221470T1 - Testiranje kože na tuberkulozu kod imunokompromitiranih osoba - Google Patents
Testiranje kože na tuberkulozu kod imunokompromitiranih osoba Download PDFInfo
- Publication number
- HRP20221470T1 HRP20221470T1 HRP20221470TT HRP20221470T HRP20221470T1 HR P20221470 T1 HRP20221470 T1 HR P20221470T1 HR P20221470T T HRP20221470T T HR P20221470TT HR P20221470 T HRP20221470 T HR P20221470T HR P20221470 T1 HRP20221470 T1 HR P20221470T1
- Authority
- HR
- Croatia
- Prior art keywords
- preparation
- use according
- antigens
- recombinant
- esat6
- Prior art date
Links
- 206010061598 Immunodeficiency Diseases 0.000 title claims 2
- 201000008827 tuberculosis Diseases 0.000 title 1
- 239000000427 antigen Substances 0.000 claims 10
- 102000036639 antigens Human genes 0.000 claims 10
- 108091007433 antigens Proteins 0.000 claims 10
- 241000187479 Mycobacterium tuberculosis Species 0.000 claims 2
- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 claims 2
- 101150079015 esxB gene Proteins 0.000 claims 2
- 208000015181 infectious disease Diseases 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 239000002953 phosphate buffered saline Substances 0.000 claims 2
- 241000194035 Lactococcus lactis Species 0.000 claims 1
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims 1
- 229920001213 Polysorbate 20 Polymers 0.000 claims 1
- 235000014897 Streptococcus lactis Nutrition 0.000 claims 1
- 230000000890 antigenic effect Effects 0.000 claims 1
- 239000000706 filtrate Substances 0.000 claims 1
- 210000002865 immune cell Anatomy 0.000 claims 1
- 238000001727 in vivo Methods 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 1
- 229940068977 polysorbate 20 Drugs 0.000 claims 1
- 102000004169 proteins and genes Human genes 0.000 claims 1
- 108090000623 proteins and genes Proteins 0.000 claims 1
- 230000000638 stimulation Effects 0.000 claims 1
- 238000012956 testing procedure Methods 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K49/00—Preparations for testing in vivo
- A61K49/0004—Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions
- A61K49/0006—Skin tests, e.g. intradermal testing, test strips, delayed hypersensitivity
-
- 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
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/02—Bacterial antigens
- A61K39/09—Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Dermatology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Pulmonology (AREA)
- Communicable Diseases (AREA)
- Diabetes (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Endocrinology (AREA)
- Gastroenterology & Hepatology (AREA)
- Pathology (AREA)
- Rheumatology (AREA)
- Toxicology (AREA)
- Urology & Nephrology (AREA)
- Oncology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Medicinal Preparation (AREA)
Claims (14)
1. Pripravak za uporabu u in vivo postupku testiranja kože za dijagnosticiranje prisutnosti latentne infekcije Mycobacterium tuberculosis (Mtb) kod imunokompromitiranih osoba ili osoba ko-inficiranih HIV-om, pri čemu pripravak sadrži koktel dva antigena Mtb rano izlučenog antigenskog cilja 6 (ESAT6) i protein filtrata kulture 10 (CFP-10).
2. Pripravak za uporabu prema zahtjevu 1, naznačen time što su dva antigena klonirana, proizvedena i pročišćena u pogodnom organizmu, npr. iz Lactococcus lactis.
3. Pripravak za uporabu prema bilo kojem od prethodnih zahtjeva, naznačen time što je pripravak sastavljen od koktela dva antigena rekombinantnog dvostrukog ESAT6 i rekombinantnog CFP-10.
4. Pripravak za uporabu prema bilo kojem od prethodnih zahtjeva, naznačen time što su antigeni pomiješani u nosaču.
5. Pripravak za uporabu prema zahtjevu 4, naznačen time što su rekombinantni dvostruki-ESAT6 i rekombinantni CFP10 pomiješani u omjeru 1:1(w/w).
6. Pripravak za uporabu prema zahtjevu 4, naznačen time što su rekombinantni dvostruki-ESAT6 i rekombinantni CFP10 pomiješani u omjerima između 1:20(w/w) i 20:1(w/w).
7. Pripravak za uporabu prema bilo kojem od prethodnih zahtjeva, naznačen time što je količina antigena između 0.25-2.0 µg/mL svakog antigena.
8. Pripravak za uporabu prema bilo kojem od zahtjeva 4-7, naznačen time što nosač sadrži fosfatno puferiranu slanu otopinu (PBS) s 0.01 % polisorbata20 i 0.5 % fenola.
9. Pripravak za uporabu prema bilo kojem od prethodnih zahtjeva, naznačen time što navedeni postupak sadrži mjerenje veličine reakcije u koži koja nastaje kao odgovor na stimulaciju imunoloških stanica intradermalnim ubrizgavanjem navedenog pripravka.
10. Pripravak za uporabu prema zahtjevu 8, naznačen time što se veličina reakcije mjeri između 48-72 sata nakon primjene navedenog pripravka.
11. Pripravak za uporabu prema bilo kojem od prethodnih zahtjeva, naznačen time što pripravak sadrži jedan ili više daljnjih antigena Mycobacterium tuberculosis.
12. Pripravak za uporabu prema zahtjevu 10, naznačen time što su daljnji antigeni odabrani iz skupine koju čine RDI ograničeni antigeni, RDI povezani antigeni, i Rv2564, Rv3865, Rv3877, Rv2348, Rv3614, Rv3615 i Rv3616.
13. Pripravak za uporabu prema bilo kojem od prethodnih zahtjeva, naznačen time što je subjekt dojenče ili dijete mlađe od 5 godina.
14. Pripravak za uporabu prema bilo kojem od prethodnih zahtjeva, pri čemu je subjektu dijagnosticirana latentna infekcija Mtb ako je otvrdnuće nakon primjene navedenog pripravka iznad unaprijed određene granice.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DKPA201500739 | 2015-11-18 | ||
| DKPA201600064 | 2016-02-01 | ||
| EP16797736.2A EP3377097B1 (en) | 2015-11-18 | 2016-11-15 | Skin testing for tuberculosis in immunocompromised persons |
| PCT/DK2016/050366 WO2017084671A1 (en) | 2015-11-18 | 2016-11-15 | Skin Testing for tuberculosis in immunocompromised persons |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20221470T1 true HRP20221470T1 (hr) | 2023-01-06 |
Family
ID=58717389
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20221470TT HRP20221470T1 (hr) | 2015-11-18 | 2016-11-15 | Testiranje kože na tuberkulozu kod imunokompromitiranih osoba |
Country Status (22)
| Country | Link |
|---|---|
| US (1) | US10786579B2 (hr) |
| EP (1) | EP3377097B1 (hr) |
| JP (2) | JP2018535977A (hr) |
| KR (1) | KR20180083898A (hr) |
| CN (1) | CN108430501B (hr) |
| AU (1) | AU2016355638B2 (hr) |
| BR (1) | BR112018009901A2 (hr) |
| CA (1) | CA3006110A1 (hr) |
| DK (1) | DK3377097T3 (hr) |
| EA (1) | EA201891129A1 (hr) |
| ES (1) | ES2933035T3 (hr) |
| FI (1) | FI3377097T3 (hr) |
| HR (1) | HRP20221470T1 (hr) |
| HU (1) | HUE060819T2 (hr) |
| LT (1) | LT3377097T (hr) |
| MX (1) | MX2018006129A (hr) |
| PL (1) | PL3377097T3 (hr) |
| PT (1) | PT3377097T (hr) |
| RS (1) | RS63819B1 (hr) |
| SI (1) | SI3377097T1 (hr) |
| WO (1) | WO2017084671A1 (hr) |
| ZA (1) | ZA201803452B (hr) |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1683009A (zh) * | 2005-03-18 | 2005-10-19 | 中国人民解放军第三○九医院 | 诊断结核菌感染、活动性结核病的特异性皮肤试剂 |
| EP1767937A1 (en) * | 2005-09-27 | 2007-03-28 | Institut National De La Sante Et De La Recherche Medicale (Inserm) | Method of diagnosis of tuberculosis related immune restoration syndrome (IRS) |
| CN101455847A (zh) * | 2007-12-12 | 2009-06-17 | 中国人民解放军总医院第二附属医院 | Esat6和cfp10蛋白在制备用于鉴定诊断结核病的药物中的应用 |
| GB201007075D0 (en) * | 2010-04-28 | 2010-06-09 | Sec Dep For Environment Food A | Diagnostic reagents |
-
2016
- 2016-11-15 PT PT167977362T patent/PT3377097T/pt unknown
- 2016-11-15 AU AU2016355638A patent/AU2016355638B2/en active Active
- 2016-11-15 DK DK16797736.2T patent/DK3377097T3/da active
- 2016-11-15 KR KR1020187016555A patent/KR20180083898A/ko not_active Application Discontinuation
- 2016-11-15 LT LTEPPCT/DK2016/050366T patent/LT3377097T/lt unknown
- 2016-11-15 BR BR112018009901A patent/BR112018009901A2/pt active Search and Examination
- 2016-11-15 HU HUE16797736A patent/HUE060819T2/hu unknown
- 2016-11-15 EP EP16797736.2A patent/EP3377097B1/en active Active
- 2016-11-15 US US15/775,673 patent/US10786579B2/en active Active
- 2016-11-15 JP JP2018525696A patent/JP2018535977A/ja active Pending
- 2016-11-15 WO PCT/DK2016/050366 patent/WO2017084671A1/en active Application Filing
- 2016-11-15 CN CN201680078388.4A patent/CN108430501B/zh active Active
- 2016-11-15 PL PL16797736.2T patent/PL3377097T3/pl unknown
- 2016-11-15 HR HRP20221470TT patent/HRP20221470T1/hr unknown
- 2016-11-15 ES ES16797736T patent/ES2933035T3/es active Active
- 2016-11-15 CA CA3006110A patent/CA3006110A1/en active Pending
- 2016-11-15 RS RS20221140A patent/RS63819B1/sr unknown
- 2016-11-15 SI SI201631641T patent/SI3377097T1/sl unknown
- 2016-11-15 EA EA201891129A patent/EA201891129A1/ru unknown
- 2016-11-15 FI FIEP16797736.2T patent/FI3377097T3/fi active
- 2016-11-15 MX MX2018006129A patent/MX2018006129A/es unknown
-
2018
- 2018-05-24 ZA ZA2018/03452A patent/ZA201803452B/en unknown
-
2022
- 2022-07-20 JP JP2022115760A patent/JP2022153501A/ja not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| CA3006110A1 (en) | 2017-05-26 |
| MX2018006129A (es) | 2019-08-12 |
| JP2018535977A (ja) | 2018-12-06 |
| HUE060819T2 (hu) | 2023-04-28 |
| CN108430501B (zh) | 2023-04-11 |
| WO2017084671A1 (en) | 2017-05-26 |
| ZA201803452B (en) | 2019-08-28 |
| SI3377097T1 (sl) | 2023-02-28 |
| KR20180083898A (ko) | 2018-07-23 |
| AU2016355638B2 (en) | 2023-02-02 |
| EA201891129A1 (ru) | 2019-02-28 |
| PL3377097T3 (pl) | 2023-01-09 |
| DK3377097T3 (da) | 2022-12-19 |
| EP3377097A1 (en) | 2018-09-26 |
| BR112018009901A2 (pt) | 2018-11-06 |
| FI3377097T3 (fi) | 2023-01-13 |
| ES2933035T3 (es) | 2023-01-31 |
| RS63819B1 (sr) | 2023-01-31 |
| AU2016355638A1 (en) | 2018-07-05 |
| LT3377097T (lt) | 2022-12-12 |
| US20190151479A1 (en) | 2019-05-23 |
| CN108430501A (zh) | 2018-08-21 |
| EP3377097B1 (en) | 2022-10-19 |
| PT3377097T (pt) | 2022-12-20 |
| JP2022153501A (ja) | 2022-10-12 |
| US10786579B2 (en) | 2020-09-29 |
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