Immunogenic Composition

• US 20080199490A1
• Filed: 06/23/2006
• Published: 08/21/2008
• Est. Priority Date: 06/27/2005
• Status: Active Grant

• Current Assignee: Glaxosmithkline Biologicals SA (GlaxoSmithKline PLC)
• Original Assignee: Glaxosmithkline Biologicals SA (GlaxoSmithKline PLC)
• Inventors: Poolman, Jan, Denoel, Philippe, Capiau, Carine, Biemans, Ralph Leon, Duvivier, Pierre, Boutriau, Dominique
• Granted Patent: US 8,431,136 B2
• Time in Patent Office: Days
• US Class Current: 424/197.11
• 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 a Hib saccharide conjugate and at least two further bacterial saccharide conjugates wherein the Hib conjugate is present in a lower saccharide dose than the mean saccharide dose of all the at least two further bacterial saccharide conjugates.

Claims

1. An immunogenic composition comprising a Hib saccharide conjugate and at least two further bacterial saccharide conjugates wherein the Hib conjugate is present in a lower saccharide dose than the mean saccharide dose of all the at least two further bacterial saccharide conjugates.

2. The immunogenic composition of claim 1 wherein the Hib conjugate is present in a lower saccharide dose than the saccharide dose of each of the at least two further bacterial saccharide conjugates.

3. The immunogenic composition of claim 1 wherein the at least two further bacterial saccharide conjugates comprise a N. meningitidis capsular saccharide derived from a strain selected from the group consisting of serogroups A, B, C, W135 and Y.

4. The immunogenic composition of claim 3 wherein the at least two further bacterial saccharide conjugates comprise N. meningitidis serogroup C capsular saccharide (MenC).

5. The immunogenic composition of claim 3 wherein the at least two further bacterial saccharide conjugates comprises N. meningitidis serogroup Y capsular saccharide (MenY).

6. The immunogenic composition of claim 3 wherein the at least two further bacterial saccharide conjugates comprise N. meningitidis serogroup A capsular saccharide (MenA).

7. The immunogenic composition of claim 3 wherein the at least two further bacterial saccharide conjugates comprise N. meningitidis serogroup W135 capsular saccharide (MenW).

8. The immunogenic composition of claim 1 comprising a N. meningitidis serogroup B outer membrane vesicle preparation.

9. The immunogenic composition of claim 1 wherein the at least two further bacterial saccharide conjugates comprise a S. pneumoniae capsular saccharide derived from a strain selected from the group consisting of serotypes 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F.

10. The immunogenic composition of claim 1 wherein the at least two further bacterial saccharide conjugates comprise a S. typhi Vi capsular saccharide.

11. The immunogenic composition of claim 1 wherein the saccharide dose of the Hib saccharide conjugate is between 0.1 and 9 μ

g, 1 and 5 μ

g or 2 and 3 μ

g of saccharide.

12. The immunogenic composition of claim 1 wherein the saccharide dose of each of the at least two further saccharide conjugates is between 2 and 20 μ

g, 3 and 10 μ

g or 4 and 7 μ

g of saccharide.

13. The immunogenic composition of claim 1 wherein the same carrier protein is used in the Hib conjugate and two or more of the at least two further bacterial saccharide conjugates.

14. The immunogenic composition of claim 1 wherein the Hib saccharide is conjugated to a carrier protein selected from the group consisting of TT, DT, CRM197, fragment C of TT, protein D, OMPC and pneumolysin.

15. The immunogenic composition of claim 1 wherein the at least two further bacterial saccharides are conjugated to a carrier protein selected from the group consisting of TT, DT, CRM197, fragment C of TT, protein D, OMPC and pneumolysin.

16. The immunogenic composition of claim 4 wherein the MenC saccharide has a molecular weight of above 50 kDa, 75 kDa, 100 kDa or an average size of between 100-200 kDa, 100-150 kDa or 150-200 kDa.

17. The immunogenic composition of claim 4 wherein the MenY saccharide, where present, has a molecular weight of above 50 kDa, 75 kDa, 100 kDa or an average size of between 60-190 kDa, 70-180 kDa, 80-170 kDa, 90-160 kDa, 100-150 kDa or 110-140 kDa.

18. The immunogenic composition of claim 4 wherein MenC is at least partially O-acetylated such that at least 30% of the repeat units are O-acetylated at least one position.

19. The immunogenic composition of claim 1 wherein MenY, where present is at least partially O-acetylated such that at least 20% of the repeat units are O-acetylated at least one position.

20. The immunogenic composition of claim 1 which contains no aluminium salts.

21. The immunogenic composition of claim 1 which is unadjuvanted.

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

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, and Haemophilus influenzae, said kit comprising a first container comprising

tetanus toxoid (TT),

diphtheria toxoid (DT), and

whole cell or acellular pertussis components;

and a second container comprising the immunogenic composition of claim 1.

24. The vaccine kit of claim 23 wherein the first container further comprises hepatitis B surface antigen, optionally adsorbed on aluminium phosphate.

25. The vaccine kit of claim 23 wherein the first or second container further comprises inactivated polio virus (IPV).

26. A process for making the immunogenic composition of claim 1 comprising the step of mixing a Hib saccharide conjugate with at least two further bacterial saccharide conjugates to form a composition in which the Hib conjugate is present in a lower saccharide dose than the mean saccharide dose of all the at least two further bacterial saccharide conjugates.

27. A method of immunising a human host against meningitis comprising administering to the host an immunoprotective dose of the immunogenic composition of claim 1.

28. A method of immunising a human host against disease caused by Haemophilus influenzae comprising administering to the host an immunoprotective dose of the immunogenic composition of claim 1.

29. The method of treating or preventing a disease caused by meningitis by administering the immunogenic composition of claim 1.

30. The method of treating or preventing a disease caused by Haemophilus influenzae by administering the immunogenic composition of claim 1.

31. (canceled)

32. (canceled)