IMMUNOGENIC COMPOSITION

• US 20090041802A1
• Filed: 06/23/2006
• Published: 02/12/2009
• Est. Priority Date: 06/27/2005
• Status: Active Grant

• Current Assignee: Glaxosmithkline Biologicals SA (GlaxoSmithKline PLC)
• Original Assignee: Glaxosmithkline Biologicals SA (GlaxoSmithKline PLC)
• Inventors: Boutriau, Dominique, Devivier, Pierre, Poolman, Jan, Denoel, Philippe, Capiau, Carine, Biemans, Ralph Leon
• Granted Patent: US 9,789,179 B2
• Time in Patent Office: Days
• US Class Current: 424/197.110
• CPC Class Codes: A61K 2039/545 characterised by the dose, timing or administration schedule
• CPC Class Codes: A61K 2039/55 characterised by the host/recipient, e.g. newborn with maternal antibodies
• CPC Class Codes: A61K 2039/575 humoral response
• CPC Class Codes: A61K 2039/6037 Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
• CPC Class Codes: A61K 2039/62 characterised by the link between antigen and carrier
• CPC Class Codes: A61K 2039/627 characterised by the linker
• CPC Class Codes: A61K 2039/70 Multivalent vaccine
• CPC Class Codes: A61K 39/0017 Combination vaccines based on whole cell diphtheria-tetanus-pertussis
• CPC Class Codes: A61K 39/0018 Combination vaccines based on acellular diphtheria-tetanus-pertussis
• CPC Class Codes: A61K 39/05 Actinobacteria, e.g. Actinomyces, Streptomyces, Nocardia, Bifidobacterium, Gardnerella, Corynebacterium; Propionibacterium Mycobacterium A61K39/04
• CPC Class Codes: A61K 39/08 Clostridium, e.g. Clostridium tetani
• CPC Class Codes: A61K 39/092 Streptococcus
• CPC Class Codes: A61K 39/095 Neisseria
• CPC Class Codes: A61K 39/099 Bordetella
• CPC Class Codes: A61K 39/102 Pasteurellales, e.g. Actinobacillus, Pasteurella; Haemophilus
• CPC Class Codes: A61K 39/116 Polyvalent bacterial antigens
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61K 39/145 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: A61K 39/292 Serum hepatitis virus, hepatitis B virus, e.g. Australia antigen
• CPC Class Codes: A61K 39/385 Haptens or antigens, bound to carriers
• CPC Class Codes: A61P 11/04 : for throat disorders
• CPC Class Codes: A61P 11/14 : Antitussive agents
• CPC Class Codes: A61P 31/00 : Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 : Antibacterial agents
• CPC Class Codes: A61P 31/12 : Antivirals
• CPC Class Codes: A61P 31/20 : for DNA viruses
• CPC Class Codes: A61P 37/00 : Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/04 : Immunostimulants
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07H 3/00 : Compounds containing only hydrogen atoms and saccharide radicals having only carbon, hydrogen, and oxygen atoms preparation by hydrolysis of di-or polysaccharides C13; separation or purification of sucrose, glucose, fructose, lactose or maltose C13
• CPC Class Codes: C12N 2730/10134 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2760/16234 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2760/16271 : Demonstrated in vivo effect
• CPC Class Codes: C12N 2770/32634 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 7/00 : Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present application discloses an immunogenic composition comprising N. meningitidis capsular polysaccharides from at least one of serogroups A, C, W135 and Y conjugated to a carrier protein to produce a N. meningitidis capsular polysaccharide conjugate, wherein the average size of each N. meningitidis polysaccharide is above 50 kDa.

Claims

1. An immunogenic composition comprising N. meningitidis capsular polysaccharides from at least one of serogroups A, C, W135 and Y comprising N. meningitidis serogroup C capsular polysaccharide having an average size of above 75 kDa, conjugated to a carrier protein to produce a N. meningitidis capsular polysaccharide conjugate, wherein the average size of each N. meningitidis polysaccharide is above above 50 kDa.

2. The immunogenic composition of claim 1 comprising N. meningitidis capsular polysaccharides from at least one of serogroups A, C, W135 and Y conjugated to a carrier protein to form N. meningitidis conjugates, wherein each N. meningitidis polysaccharide is either a native polysaccharide or is sized by a factor of no more than x10.

3. The immunogenic composition of claim 1 wherein each N. meningitidis capsular polysaccharide is a native polysaccharide.

4. The immunogenic composition of claim 1 wherein at least one N. meningitidis capsular polysaccharide is sized by microfluidization.

5. The immunogenic composition of claim 1 wherein each N. meningitidis capsular polysaccharide is sized by a factor of no more than x10.

6. The immunogenic composition of claim 1 wherein the N. meningitidis conjugates are made from a mixture of native polysaccharides and polysaccharides that are sized by a factor of no more than x10.

7. The immunogenic composition of claim 6 wherein capsular polysaccharides from serogroup Y are sized by a factor of no more than x10.

8. The immunogenic composition of claim 6 wherein capsular polysaccharides from serogroups A and C are native and polysaccharides from serogroups W135 and Y are sized by a factor of no more than x10.

9. The immunogenic composition of claim 1 wherein the average size of each N. meningitidis capular polysaccharide is between 50 kDa and 300 KDa or 50 kDa and 200 kDa.

10. The immunogenic composition of claim 1 comprising a MenA capsular polysaccharide having an average size of above 50 kDa, 75 kDa, 100 kDa or an average size of between 50-100 kDa or 55-90 KDa or 60-80 kDa.

11. The immunogenic composition of claim 1 comprising a MenC capsular polysaccharide having an average size of above 100 kDa or between 100-200 kDa, 100-150 kDa, 80-120 kDa, 90-110 kDa, 150-200 kDa, 120-240 kDa, 140-220 kDa, 160-200 kDa or 190-200 kDa.

12. The immunogenic composition of claim 1 comprising a MenY capsular polysaccharide, having an average size of above 50 kDa, 75 kDa, 100 kDa or between 60-190 kDa or 70-180 kDa or 80-170 kDa or 90-160 kDa or 100-150 kDa, 110-145 kDa or 120-140 kDa.

13. The immunogenic composition of any one of claim 1 comprising a MenW capsular polysaccharide having an average size of above 50 kDa, 75 kDa, 100 kDa or between 60-190 kDa or 70-180 kDa or 80-170 kDa or 90-160 kDa or 100-150 kDa, 140-180 kDa, 150-170 kDa or 110-140 kDa.

14. The immunogenic composition claim 1 wherein each N. meningitidis capsular polysaccharide is conjugated to a carrier protein independently selected from the group consisting of TT, DT, CRM197, fragment C of TT and protein D.

15. The immunogenic composition of claim 1 wherein each N. meningitidis capsular polysaccharide is conjugated to the same carrier protein selected from the group consisting of TT, DT, CRM197, fragment C of TT and protein D.

16. The immunogenic composition of claim 1 further comprising a H. influenzae b capsular saccharide conjugated to a carrier protein.

17. The immunogenic composition of claim 16 wherein the H. influenzae b capsular saccharide is conjugated to a carrier protein selected from the group consisting of TT, DT, CRM 197, fragment C of TT and protein D.

18. The immunogenic composition claim 16 comprising a Hib saccharide conjugate and at least two further bacterial saccharide conjugates wherein the Hib conjugate is present in a lower dose than the mean dose of the at least two further bacterial saccharide conjugates.

19. The immunogenic composition of claim 18 wherein the Hib conjugate is present in a lower dose than the dose of each of the at least two further bacterial saccharide conjugates.

20. The immunogenic composition of claim 16 wherein the same carrier protein is used in the Hib conjugate and two or more of the at least two further bacterial saccharide conjugates.

21. The immunogenic composition of claim 1 comprising a N. meningitidis serogroup B outer membrane vesicle preparation or capsular saccharide.

22. A vaccine comprising the immunogenic composition of claim 1 and a pharmaceutically acceptable carrier.

23. A vaccine kit for concomitant or sequential administration comprising two multi-valent immunogenic compositions for conferring protection in a host against disease caused by Bordetella pertussis, Clostridium tetani, Corynebacterium diphtheriae, Haemophilus influenzae and Neisseria meningitidis, said kit comprising a first container comprising:

tetanus toxoid (TT),

diphtheria toxoid (DT), and

wholecell or acellular pertussis components

and a second container comprising;

the immunogenic composition of claim 1.

24. A process for making the vaccine of claim 22 comprising the step of mixing the immunogenic composition of claim 1 with a pharmaceutically acceptable carrier.

25. A method of immunising a human host against disease caused by Neisseria meningitidis infection comprising administering to the host an immunoprotective dose of the immunogenic composition or vaccine of claim 1 or 23.

26. The method of treating or preventing a disease caused by Neisseria meningitidis comprising administering an immunogenic composition of claim 1.

27. (canceled)