DK2788023T3 - Aluminiumforbindelser til anvendelse i terapeutiske midler og vacciner - Google Patents
Aluminiumforbindelser til anvendelse i terapeutiske midler og vacciner Download PDFInfo
- Publication number
- DK2788023T3 DK2788023T3 DK12795830.4T DK12795830T DK2788023T3 DK 2788023 T3 DK2788023 T3 DK 2788023T3 DK 12795830 T DK12795830 T DK 12795830T DK 2788023 T3 DK2788023 T3 DK 2788023T3
- Authority
- DK
- Denmark
- Prior art keywords
- aqueous composition
- aluminium
- protein
- heavy metal
- content
- Prior art date
Links
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
- A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/02—Bacterial antigens
- A61K39/104—Pseudomonadales, e.g. Pseudomonas
-
- 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
- A61K39/12—Viral antigens
-
- 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
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
- A61K2039/525—Virus
- A61K2039/5252—Virus inactivated (killed)
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
- C12N2770/00011—Details
- C12N2770/24011—Flaviviridae
- C12N2770/24111—Flavivirus, e.g. yellow fever virus, dengue, JEV
- C12N2770/24134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Immunology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Inorganic Chemistry (AREA)
- Virology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
Claims (14)
1. En fremgangsmåde til fremstilling af en vandig sammensætning omfattende aluminium, en reaktiv forbindelse og et japansk encephalitisvirus (JEV) protein, hvor fremgangsmåden øger stabiliteten af en JEV-vaccine, og hvor 5 fremgangsmåden omfatter - at vælge et aluminiumsalt der er i stand til at tilvejebringe en vandig sammensætning med mindre end 350 ppb tungmetal og med mindre end 1,25 ppb Cu baseret på vægten af den vandige sammensætning og - at kombinere aluminiumsaltet, den reaktive forbindelse, JEV-proteinet og 10 vand for at få den vandige sammensætning; og hvor den reaktive forbindelse er valgt fra gruppen bestående af en redox-aktiv forbindelse, en radikal byggeforbindelse, en stabiliserende forbindelse og en kombination af en hvilken som helst deraf.
2. Fremgangsmåde ifølge krav 1, yderligere omfattende buffering af den vandige sammensætning ved en pH på mellem 6,5 og 8,5.
3. Vandig sammensætning omfattende et JEV-protein og et aluminiumsalt, hvilken sammensætning omfatter mindre end 350 ppb tungmetal og mindre end 1,25 ppb 20 Cu baseret på vægten af den vandige sammensætning.
4. Vandig sammensætning ifølge krav 3, der kan lagres ved temperaturer højere end 20°C i mindst 1 måned.
5. Vandig sammensætning ifølge krav 3 eller krav 4, hvor tungmetallerne er valgt fra Ni, W, Co, Os, Ru, Cd, Ag, Fe, V.
6. Vandig sammensætning ifølge krav 3-4, hvor tungmetallerne er valgt fra Fe eller Ni. 30
7. Vandig sammensætning ifølge krav 3-6, hvor aluminiumsaltet er aluminiumhydroxid (AI(OH)3).
8. Vandig sammensætning ifølge krav 3-7, omfattende mellem 5 pg/ml og 50 5 mg/ml aluminium.
9. Vandig sammensætning ifølge krav 3-8, omfattende mellem 5 ppb og 250 ppb Fe baseret på vægten af den vandige sammensætning.
10. Vandig sammensætning ifølge krav 3-9, yderligere omfattende en reaktiv forbindelse, hvor den reaktive forbindelse er valgt fra gruppen bestående af en redox-aktiv forbindelse, en radikal byggeforbindelse, en stabiliserende forbindelse og en kombination af en hvilken som helst deraf.
11. JEV-vaccine omfattende vandig sammensætning ifølge krav 3-10.
12. Fremgangsmåde til fremstilling afen vandig sammensætning omfattende mellem 5 pgram/ml og 50 mg/ml aluminium, en reaktiv forbindelse og et JEV protein hvor denne fremgangsmåde øger stabiliteten af en JEV vaccine og hvor 20 denne fremgangsmåde omfatter - at vælge et aluminiumsalt der er i stand til at tilvejebringe en vandig sammensætning med mindre end 450 ppm tungmetal og med mindre end 2,5 ppm Cu baseret på vægten af aluminium (gram/gram) and - at kombinere aluminiumsaltet, den reaktive forbindelse, JEV-proteinet og 25 vand for at producere den vandige sammensætning, hvor den reaktive forbindelse er valgt fra gruppen bestående af en redox-aktiv forbindelse, en radikal byggeforbindelse, en stabiliserende forbindelse og en kombination af en hvilken som helst deraf.
13. Vandig sammensætning omfattende et JEV-protein og et aluminiumsalt, hvilken sammensætning omfatter mellem 5 pgram/ml og 50 mg/ml aluminiumsalt og omfattende mindre end 450 ppm tungmetal og mindre end 2,5 ppm Cu baseret på vægten af aluminiumet i sammensætningen.
14. Vandig sammensætning ifølge krav 13, der kan opbevares ved temperaturer 5 højere end 20°C i mindst 1 måned.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP11192230 | 2011-12-06 | ||
| PCT/EP2012/054387 WO2013135274A1 (en) | 2012-03-13 | 2012-03-13 | Aluminium compounds for use in therapeutics and vaccines |
| PCT/EP2012/074701 WO2013083726A1 (en) | 2011-12-06 | 2012-12-06 | Aluminium compounds for use in therapeutics and vaccines |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2788023T3 true DK2788023T3 (da) | 2016-12-19 |
Family
ID=47294919
Family Applications (6)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK17185526.5T DK3269386T3 (da) | 2011-12-06 | 2012-12-06 | Aluminiumforbindelser til anvendelse inden for behandling og i vacciner |
| DK20184308.3T DK3785730T3 (da) | 2011-12-06 | 2012-12-06 | Aluminiumforbindelser til anvendelse i terapeutiske produkter og vacciner |
| DK12795830.4T DK2788023T3 (da) | 2011-12-06 | 2012-12-06 | Aluminiumforbindelser til anvendelse i terapeutiske midler og vacciner |
| DK16183076.5T DK3106176T3 (da) | 2011-12-06 | 2012-12-06 | Aluminiumforbindelser til anvendelse i terapeutika og vacciner |
| DKBA201300193U DK201300193U1 (da) | 2011-12-06 | 2013-12-09 | Aluminiumforbindelser til anvendelse i terapeutiske produkter og vacciner. |
| DKBA201300194U DK201300194U1 (da) | 2011-12-06 | 2013-12-09 | Aluminiumhydroxidkoncentrat, fortrinsvis til anvendelse i fremstillingen af en vaccine |
Family Applications Before (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK17185526.5T DK3269386T3 (da) | 2011-12-06 | 2012-12-06 | Aluminiumforbindelser til anvendelse inden for behandling og i vacciner |
| DK20184308.3T DK3785730T3 (da) | 2011-12-06 | 2012-12-06 | Aluminiumforbindelser til anvendelse i terapeutiske produkter og vacciner |
Family Applications After (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK16183076.5T DK3106176T3 (da) | 2011-12-06 | 2012-12-06 | Aluminiumforbindelser til anvendelse i terapeutika og vacciner |
| DKBA201300193U DK201300193U1 (da) | 2011-12-06 | 2013-12-09 | Aluminiumforbindelser til anvendelse i terapeutiske produkter og vacciner. |
| DKBA201300194U DK201300194U1 (da) | 2011-12-06 | 2013-12-09 | Aluminiumhydroxidkoncentrat, fortrinsvis til anvendelse i fremstillingen af en vaccine |
Country Status (15)
| Country | Link |
|---|---|
| EP (5) | EP3106176B1 (da) |
| CY (1) | CY1119927T1 (da) |
| DE (1) | DE202012012768U1 (da) |
| DK (6) | DK3269386T3 (da) |
| ES (2) | ES2930458T3 (da) |
| FI (1) | FI3785730T3 (da) |
| HR (1) | HRP20171871T1 (da) |
| HU (1) | HUE037325T2 (da) |
| LT (1) | LT3106176T (da) |
| NO (1) | NO3106176T3 (da) |
| PL (2) | PL3269386T3 (da) |
| PT (2) | PT3106176T (da) |
| RS (1) | RS56709B1 (da) |
| SI (1) | SI3106176T1 (da) |
| WO (1) | WO2013083726A1 (da) |
Families Citing this family (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3106176B1 (en) | 2011-12-06 | 2017-10-11 | Valneva Austria GmbH | Aluminium compounds for use in therapeutics and vaccines |
| US9895437B2 (en) | 2012-04-18 | 2018-02-20 | Valneva Austria Gmbh | Aluminum compounds for use in therapeutics and vaccines |
| BR112017003462B1 (pt) * | 2014-09-03 | 2023-02-14 | Intervet International B.V. | Coronavírus bovino atenuado e vacina |
| EP4218807A3 (en) | 2015-12-23 | 2023-09-06 | Valneva Austria GmbH | Zika virus vaccine |
| US11998599B2 (en) | 2016-12-30 | 2024-06-04 | Vaxcyte, Inc. | Polypeptide-antigen conjugates with non-natural amino acids |
| US11951165B2 (en) | 2016-12-30 | 2024-04-09 | Vaxcyte, Inc. | Conjugated vaccine carrier proteins |
| CA3059817A1 (en) | 2017-04-13 | 2018-10-18 | Valneva Austria Gmbh | Multivalent ospa polypeptides and methods and uses relating thereto |
| BR112020003470B1 (pt) | 2017-09-21 | 2023-09-26 | Valneva Se | Composições farmacêuticas compreendendo o vírus imunogênico de chikungunya chikv-delta5nsp3, processo e uso das mesmas |
| WO2019090233A2 (en) | 2017-11-03 | 2019-05-09 | Takeda Vaccines, Inc. | Method for inactivating zika virus and for determining the completeness of inactivation |
| KR20200090893A (ko) | 2017-11-30 | 2020-07-29 | 다케다 백신즈 인코포레이티드 | 지카 바이러스를 비활성화시키기 위한 방법, 및 관련 방법들 |
| US20210275662A1 (en) | 2018-07-13 | 2021-09-09 | Valneva Se | Method for rescuing and producing a virus in avian cells |
| GB2598494B (en) | 2019-05-20 | 2024-07-24 | Valneva Se | A subunit vaccine for treatment or prevention of a respiratory tract infection |
| EP4114457A4 (en) * | 2020-03-01 | 2023-08-09 | Dynavax Technologies Corporation | CORONAVIRUS VACCINES INCLUDING A TLR9 AGONIST |
| WO2021178306A1 (en) * | 2020-03-01 | 2021-09-10 | Dynavax Technologies Corporation | Coronavirus vaccines comprising a tlr9 agonist |
| EP3895729A1 (en) | 2020-03-01 | 2021-10-20 | Valneva Austria GmbH | Cpg-adjuvanted sars-cov-2 virus vaccine |
| AU2021230501A1 (en) * | 2020-03-01 | 2022-10-27 | Dynavax Technologies Corporation | Coronavirus vaccines comprising a TLR9 agonist |
| IL296071A (en) | 2020-03-01 | 2022-11-01 | Valneva Austria Gmbh | Sars-cov-2 virus vaccine with adjuvant cytidine-phosphoguanosine |
| TW202203967A (zh) | 2020-04-06 | 2022-02-01 | 奧地利商瓦爾尼瓦奧地利有限責任公司 | 不活化ＳＡＲＳ—ＣｏＶ—２病毒疫苗 |
| WO2021205022A1 (en) | 2020-04-09 | 2021-10-14 | Valneva Austria Gmbh | Improved methods of producing a lipidated protein |
| WO2022214678A2 (en) | 2021-04-09 | 2022-10-13 | Valneva Se | Human metapneumo virus vaccine |
| WO2023148256A1 (en) | 2022-02-02 | 2023-08-10 | Valneva Austria Gmbh | Inactivated sars-cov-2 virus vaccine |
| WO2023232901A1 (en) | 2022-06-01 | 2023-12-07 | Valneva Austria Gmbh | Clostridium difficile vaccine |
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| US4057685A (en) | 1972-02-02 | 1977-11-08 | Abbott Laboratories | Chemically modified endotoxin immunizing agent |
| US4761372A (en) | 1981-01-12 | 1988-08-02 | New York University | Mutant enterotoxin of E. coli |
| US4673574A (en) | 1981-08-31 | 1987-06-16 | Anderson Porter W | Immunogenic conjugates |
| US4459286A (en) | 1983-01-31 | 1984-07-10 | Merck & Co., Inc. | Coupled H. influenzae type B vaccine |
| US4663160A (en) | 1983-03-14 | 1987-05-05 | Miles Laboratories, Inc. | Vaccines for gram-negative bacteria |
| US4761283A (en) | 1983-07-05 | 1988-08-02 | The University Of Rochester | Immunogenic conjugates |
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| US4695624A (en) | 1984-05-10 | 1987-09-22 | Merck & Co., Inc. | Covalently-modified polyanionic bacterial polysaccharides, stable covalent conjugates of such polysaccharides and immunogenic proteins with bigeneric spacers, and methods of preparing such polysaccharides and conjugates and of confirming covalency |
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| NL8802046A (nl) | 1988-08-18 | 1990-03-16 | Gen Electric | Polymeermengsel met polyester en alkaansulfonaat, daaruit gevormde voorwerpen. |
| CA2059693C (en) | 1991-01-28 | 2003-08-19 | Peter J. Kniskern | Polysaccharide antigens from streptococcus pneumoniae |
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| HUP0103100A3 (en) | 1998-08-19 | 2005-11-28 | Baxter Healthcare Sa | Immunogenic betha-propionamido-linked polysaccharide protein conjugate useful as a vaccine produced using an n-acryloylated polysaccharide |
| AU2002250071B2 (en) | 2001-02-13 | 2008-02-14 | Government Of The United States, As Represented By The Secretary Of The Army | Vaccine for transcutaneous immunization |
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| CN101734698B (zh) | 2009-09-08 | 2013-01-09 | 东北大学 | 一种由含铝物料制备氧化铝的方法 |
| EP3106176B1 (en) | 2011-12-06 | 2017-10-11 | Valneva Austria GmbH | Aluminium compounds for use in therapeutics and vaccines |
-
2012
- 2012-12-06 EP EP16183076.5A patent/EP3106176B1/en not_active Revoked
- 2012-12-06 DE DE202012012768.3U patent/DE202012012768U1/de not_active Expired - Lifetime
- 2012-12-06 HU HUE16183076A patent/HUE037325T2/hu unknown
- 2012-12-06 ES ES17185526T patent/ES2930458T3/es active Active
- 2012-12-06 WO PCT/EP2012/074701 patent/WO2013083726A1/en active Application Filing
- 2012-12-06 LT LTEP16183076.5T patent/LT3106176T/lt unknown
- 2012-12-06 DK DK17185526.5T patent/DK3269386T3/da active
- 2012-12-06 RS RS20171241A patent/RS56709B1/sr unknown
- 2012-12-06 EP EP20184308.3A patent/EP3785730B1/en active Active
- 2012-12-06 ES ES16183076.5T patent/ES2647882T3/es active Active
- 2012-12-06 FI FIEP20184308.3T patent/FI3785730T3/fi active
- 2012-12-06 EP EP24167413.4A patent/EP4400115A2/en active Pending
- 2012-12-06 DK DK20184308.3T patent/DK3785730T3/da active
- 2012-12-06 DK DK12795830.4T patent/DK2788023T3/da active
- 2012-12-06 PL PL17185526.5T patent/PL3269386T3/pl unknown
- 2012-12-06 SI SI201231133T patent/SI3106176T1/en unknown
- 2012-12-06 NO NO16183076A patent/NO3106176T3/no unknown
- 2012-12-06 PT PT161830765T patent/PT3106176T/pt unknown
- 2012-12-06 EP EP17185526.5A patent/EP3269386B1/en active Active
- 2012-12-06 PT PT171855265T patent/PT3269386T/pt unknown
- 2012-12-06 DK DK16183076.5T patent/DK3106176T3/da active
- 2012-12-06 EP EP12795830.4A patent/EP2788023B1/en active Active
- 2012-12-06 PL PL16183076T patent/PL3106176T3/pl unknown
-
2013
- 2013-12-09 DK DKBA201300193U patent/DK201300193U1/da not_active IP Right Cessation
- 2013-12-09 DK DKBA201300194U patent/DK201300194U1/da not_active Application Discontinuation
-
2017
- 2017-12-04 HR HRP20171871TT patent/HRP20171871T1/hr unknown
-
2018
- 2018-01-10 CY CY20181100033T patent/CY1119927T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| NO3106176T3 (da) | 2018-03-10 |
| HUE037325T2 (hu) | 2018-08-28 |
| DK3785730T3 (da) | 2024-05-06 |
| PL3106176T3 (pl) | 2018-03-30 |
| DK201300194U1 (da) | 2014-01-17 |
| DE202012012768U1 (de) | 2014-01-21 |
| EP2788023B1 (en) | 2016-11-02 |
| EP3785730A1 (en) | 2021-03-03 |
| PT3269386T (pt) | 2022-12-05 |
| ES2930458T3 (es) | 2022-12-13 |
| LT3106176T (lt) | 2018-01-10 |
| FI3785730T3 (fi) | 2024-05-06 |
| DK201300193U1 (da) | 2014-01-17 |
| EP3106176A1 (en) | 2016-12-21 |
| EP2788023A1 (en) | 2014-10-15 |
| EP3269386A1 (en) | 2018-01-17 |
| PL3269386T3 (pl) | 2022-12-05 |
| DK3106176T3 (da) | 2018-01-08 |
| CY1119927T1 (el) | 2018-12-12 |
| WO2013083726A1 (en) | 2013-06-13 |
| PT3106176T (pt) | 2017-12-20 |
| HRP20171871T1 (hr) | 2018-01-12 |
| RS56709B1 (sr) | 2018-03-30 |
| EP4400115A2 (en) | 2024-07-17 |
| ES2647882T3 (es) | 2017-12-27 |
| DK3269386T3 (da) | 2022-10-24 |
| EP3269386B1 (en) | 2022-09-14 |
| EP3106176B1 (en) | 2017-10-11 |
| EP3785730B1 (en) | 2024-04-24 |
| SI3106176T1 (en) | 2018-04-30 |
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