HRP20220573T1 - Imunogeni pripravci, namijenjeni upotrebi u pneumokoknim cjepivima - Google Patents
Imunogeni pripravci, namijenjeni upotrebi u pneumokoknim cjepivima Download PDFInfo
- Publication number
- HRP20220573T1 HRP20220573T1 HRP20220573TT HRP20220573T HRP20220573T1 HR P20220573 T1 HRP20220573 T1 HR P20220573T1 HR P20220573T T HRP20220573T T HR P20220573TT HR P20220573 T HRP20220573 T HR P20220573T HR P20220573 T1 HRP20220573 T1 HR P20220573T1
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- Prior art keywords
- intended
- pneumoniae
- serotypes
- accordance
- immunogenic preparation
- Prior art date
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- 230000002163 immunogen Effects 0.000 title claims 17
- 239000000203 mixture Substances 0.000 title 1
- 229960001973 pneumococcal vaccines Drugs 0.000 title 1
- 241000894006 Bacteria Species 0.000 claims 12
- 239000002775 capsule Substances 0.000 claims 3
- 150000004676 glycans Chemical class 0.000 claims 3
- 208000015181 infectious disease Diseases 0.000 claims 3
- 229920001282 polysaccharide Polymers 0.000 claims 3
- 239000005017 polysaccharide Substances 0.000 claims 3
- 102000014914 Carrier Proteins Human genes 0.000 claims 2
- 108010078791 Carrier Proteins Proteins 0.000 claims 2
- 150000001720 carbohydrates Chemical class 0.000 claims 2
- 238000000338 in vitro Methods 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 230000000625 opsonophagocytic effect Effects 0.000 claims 2
- 108010071134 CRM197 (non-toxic variant of diphtheria toxin) Proteins 0.000 claims 1
- 238000002965 ELISA Methods 0.000 claims 1
- 238000006640 acetylation reaction Methods 0.000 claims 1
- 239000002671 adjuvant Substances 0.000 claims 1
- 238000003556 assay Methods 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 230000003053 immunization Effects 0.000 claims 1
- 230000000116 mitigating effect Effects 0.000 claims 1
- 238000006268 reductive amination reaction Methods 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
- A61K39/09—Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
- A61K39/092—Streptococcus
-
- 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
- A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
-
- 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
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
-
- 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
- A61K2039/55505—Inorganic adjuvants
-
- 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
- A61K2039/58—Medicinal preparations containing antigens or antibodies raising an immune response against a target which is not the antigen used for immunisation
-
- 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
- A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
- A61K2039/6031—Proteins
- A61K2039/6037—Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
-
- 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
- A61K2039/70—Multivalent vaccine
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Immunology (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Microbiology (AREA)
- Epidemiology (AREA)
- Mycology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
Claims (15)
1. Imunogeni pripravak koji sadrži najmanje jedan glikokonjugat polisaharida kapsule iz serotipa 18C bakterije S. pneumoniae kovalentno vezan na protein-nosač, te što dodatno sadrži glikokonjugate polisaharida kapsule iz serotipova 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F i 23F bakterije S. pneumoniae kovalentno vezane na protein-nosač, gdje su navedeni glikokonjugati pojedinačno konjugirani s CRM197, naznačen time što je namijenjen upotrebi u postupku imuniziranja subjekta protiv infekcije serotipovima 18A, 18B i/ili 18F bakterije S. pneumoniae, gdje navedeni pripravak ne sadrži saharid kapsule iz serotipova 18A, 18B i 18F bakterije S. pneumoniae.
2. Imunogeni pripravak, namijenjen upotrebi u skladu s patentnim zahtjevom 1, naznačen time što dodatno sadrži glikokonjugate iz serotipova 22F i 33F bakterije S. pneumoniae.
3. Imunogeni pripravak, namijenjen upotrebi u skladu s patentnim zahtjevom 1, naznačen time što dodatno sadrži glikokonjugate iz serotipova 15B, 22F i 33F bakterije S. pneumoniae.
4. Imunogeni pripravak, namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1-3, naznačen time što dodatno sadrži glikokonjugate iz serotipova 12F, 10A, 11A i 8 bakterije S. pneumoniae.
5. Imunogeni pripravak, namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1-4, naznačen time što je 13-, 14-, 15-, 16-, 17-, 18-, 19-, 20-, 21-, 22-, 23-, 24- ili 25-erovalentni pneumokokni konjugatni pripravak.
6. Imunogeni pripravak, namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1-5, naznačen time što se navedeni glikokonjugat iz serotipa 18C bakterije S. pneumoniae pripravlja reduktivnim aminiranjem.
7. Imunogeni pripravak, namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1-6, naznačen time što navedeni glikokonjugat iz serotipa 18C bakterije S. pneumoniae sadrži saharid kod kojeg je stupanj O-acetiliranja ≤ 10%.
8. Imunogeni pripravak, namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1-7, naznačen time što navedeni imunogeni pripravak dodatno sadrži najmanje jedan adjuvans.
9. Imunogeni pripravak, namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1-8, naznačen time što može proizvesti IgG protutijela kod čovjeka koja se mogu vezati na serotipove 18A, 18B i/ili 18F bakterije S. pneumoniae polisaharid u koncentraciji od najmanje 0,35 mg/ml, što je određeno ELISA ispitivanjem.
10. Imunogeni pripravak, namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1-9, naznačen time što može proizvesti funkcionalna protutijela kod čovjeka koja mogu usmrćivati serotipove 18A, 18B i/ili 18F bakterije S. pneumoniae, što je određeno opsonofagocitnim ispitivanjem (OPA) in vitro.
11. Imunogeni pripravak, namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1-10, naznačen time što može postići titar od najmanje 1:8 protiv serotipova 18A, 18B i/ili 18F bakterije S. pneumoniae kod najmanje 50% subjekata, što je određeno ispitivanjem na opsonofagocitno usmrćivanje (OPA) in vitro.
12. Imunogeni pripravak, namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1-11, naznačen time što može značajno povećati udio odgovaratelja protiv serotipova 18A, 18B i/ili 18F bakterije S. pneumoniae u usporedbi s predimuniziranom populacijom.
13. Imunogeni pripravak, namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1-12, naznačen time što može značajno povećati titre OPA kod ljudski subjekata protiv serotipova 18A, 18B i/ili 18F bakterije S. pneumoniae u usporedbi s predimuniziranom populacijom.
14. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1-13, naznačen time što je namijenjen upotrebi u postupku sprječavanja, liječenja ili ublažavanja infekcije, bolesti ili stanja kojeg uzrokuju serotipovi 18A, 18B i/ili 18F bakterije S. pneumoniae kod subjekta.
15. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1-13, naznačen time što je namijenjen upotrebi koja sprječava infekciju serotipovima 18A, 18B i/ili 18F bakterije S. pneumoniae kod subjekta.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762448485P | 2017-01-20 | 2017-01-20 | |
| PCT/IB2018/050084 WO2018134693A1 (en) | 2017-01-20 | 2018-01-05 | Immunogenic compositions for use in pneumococcal vaccines |
| EP18701573.0A EP3570879B1 (en) | 2017-01-20 | 2018-01-05 | Immunogenic compositions for use in pneumococcal vaccines |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20220573T1 true HRP20220573T1 (hr) | 2022-06-10 |
Family
ID=61028107
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20220573TT HRP20220573T1 (hr) | 2017-01-20 | 2018-01-05 | Imunogeni pripravci, namijenjeni upotrebi u pneumokoknim cjepivima |
Country Status (18)
| Country | Link |
|---|---|
| US (2) | US11413344B2 (hr) |
| EP (1) | EP3570879B1 (hr) |
| JP (1) | JP7120767B2 (hr) |
| KR (1) | KR102459629B1 (hr) |
| CN (1) | CN110198735A (hr) |
| AU (1) | AU2018208844B2 (hr) |
| BR (1) | BR112019014833A2 (hr) |
| CA (1) | CA3050622A1 (hr) |
| DK (1) | DK3570879T3 (hr) |
| ES (1) | ES2911490T3 (hr) |
| HR (1) | HRP20220573T1 (hr) |
| HU (1) | HUE059252T2 (hr) |
| IL (1) | IL268168A (hr) |
| MX (1) | MX2019008564A (hr) |
| PL (1) | PL3570879T3 (hr) |
| RU (1) | RU2762723C2 (hr) |
| SI (1) | SI3570879T1 (hr) |
| WO (1) | WO2018134693A1 (hr) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10105431B2 (en) * | 2014-01-21 | 2018-10-23 | Pfizer Inc. | Streptococcus pneumoniae capsular polysaccharides and conjugates thereof |
| KR102225282B1 (ko) * | 2015-07-21 | 2021-03-10 | 화이자 인코포레이티드 | 접합된 캡슐형 사카라이드 항원을 포함하는 면역원성 조성물, 그를 포함하는 키트 및 그의 용도 |
| US11951165B2 (en) | 2016-12-30 | 2024-04-09 | Vaxcyte, Inc. | Conjugated vaccine carrier proteins |
| EP3562503A2 (en) | 2016-12-30 | 2019-11-06 | Sutrovax, Inc. | Polypeptide-antigen conjugates with non-natural amino acids |
| US11197921B2 (en) | 2017-01-31 | 2021-12-14 | Merck Sharp & Dohme Corp. | Methods for making polysaccharide-protein conjugates |
| US11090374B2 (en) | 2017-02-24 | 2021-08-17 | Merck Sharp & Dohme Corp. | Enhancing immunogenicity of Streptococcus pneumoniae polysaccharide-protein conjugates |
| US10729763B2 (en) | 2017-06-10 | 2020-08-04 | Inventprise, Llc | Mixtures of polysaccharide-protein pegylated compounds |
| KR20200051005A (ko) | 2017-09-07 | 2020-05-12 | 머크 샤프 앤드 돔 코포레이션 | 폐렴구균 폴리사카라이드 및 면역원성 폴리사카라이드-담체 단백질 접합체에서의 그의 용도 |
| BR112020004471A8 (pt) | 2017-09-07 | 2022-11-01 | Merck Sharp & Dohme | Polissacarídeos pneumocócicos e uso dos mesmos em conjugados imunogênicos polissacarídeo-proteína carreadora |
| CN111683678B (zh) | 2017-12-06 | 2024-01-26 | 默沙东有限责任公司 | 包含肺炎链球菌多糖蛋白缀合物的组合物及其使用方法 |
| KR20210005158A (ko) | 2018-04-30 | 2021-01-13 | 머크 샤프 앤드 돔 코포레이션 | 스트렙토코쿠스 뉴모니아에 피막 폴리사카라이드 담체 단백질 접합체를 제조하는 방법 |
| KR20210002641A (ko) | 2018-04-30 | 2021-01-08 | 머크 샤프 앤드 돔 코포레이션 | 디메틸술폭시드 중의 동결건조된 돌연변이체 디프테리아 독소의 균질 용액을 제공하는 방법 |
| CA3123414A1 (en) | 2018-12-19 | 2020-06-25 | Merck Sharp & Dohme Corp. | Compositions comprising streptococcus pneumoniae polysaccharide-protein conjugates and methods of use thereof |
| CA3195083A1 (en) * | 2020-09-10 | 2022-03-17 | United Immunity, Co., Ltd. | Complex |
| EP4243863A2 (en) | 2020-11-10 | 2023-09-20 | Pfizer Inc. | Immunogenic compositions comprising conjugated capsular saccharide antigens and uses thereof |
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-
2018
- 2018-01-05 EP EP18701573.0A patent/EP3570879B1/en active Active
- 2018-01-05 AU AU2018208844A patent/AU2018208844B2/en active Active
- 2018-01-05 WO PCT/IB2018/050084 patent/WO2018134693A1/en active Application Filing
- 2018-01-05 MX MX2019008564A patent/MX2019008564A/es unknown
- 2018-01-05 US US16/478,265 patent/US11413344B2/en active Active
- 2018-01-05 ES ES18701573T patent/ES2911490T3/es active Active
- 2018-01-05 SI SI201830655T patent/SI3570879T1/sl unknown
- 2018-01-05 PL PL18701573T patent/PL3570879T3/pl unknown
- 2018-01-05 RU RU2019122619A patent/RU2762723C2/ru active
- 2018-01-05 DK DK18701573.0T patent/DK3570879T3/da active
- 2018-01-05 CN CN201880007697.1A patent/CN110198735A/zh active Pending
- 2018-01-05 CA CA3050622A patent/CA3050622A1/en active Pending
- 2018-01-05 HR HRP20220573TT patent/HRP20220573T1/hr unknown
- 2018-01-05 HU HUE18701573A patent/HUE059252T2/hu unknown
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Also Published As
| Publication number | Publication date |
|---|---|
| DK3570879T3 (da) | 2022-04-11 |
| MX2019008564A (es) | 2019-09-19 |
| EP3570879A1 (en) | 2019-11-27 |
| BR112019014833A2 (pt) | 2020-04-14 |
| RU2019122619A3 (hr) | 2021-02-20 |
| ES2911490T3 (es) | 2022-05-19 |
| AU2018208844B2 (en) | 2021-02-25 |
| KR102459629B1 (ko) | 2022-10-28 |
| RU2762723C2 (ru) | 2021-12-22 |
| WO2018134693A1 (en) | 2018-07-26 |
| KR20190097176A (ko) | 2019-08-20 |
| EP3570879B1 (en) | 2022-03-30 |
| CA3050622A1 (en) | 2018-07-26 |
| PL3570879T3 (pl) | 2022-06-20 |
| US20190343946A1 (en) | 2019-11-14 |
| JP2018115159A (ja) | 2018-07-26 |
| HUE059252T2 (hu) | 2022-11-28 |
| JP7120767B2 (ja) | 2022-08-17 |
| US11413344B2 (en) | 2022-08-16 |
| SI3570879T1 (sl) | 2022-06-30 |
| RU2019122619A (ru) | 2021-02-20 |
| US20230190907A1 (en) | 2023-06-22 |
| IL268168A (en) | 2019-09-26 |
| CN110198735A (zh) | 2019-09-03 |
| AU2018208844A1 (en) | 2019-07-11 |
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