Immunogenic composition

Patent metadata

Field	Value
Publication number	US-9561268-B2
Application number	US-201313826696-A
Country	US
Kind code	B2
Filing date	Mar 14, 2013
Priority date	Oct 17, 2012
Publication date	Feb 7, 2017
Grant date	Feb 7, 2017

Abstract

The present invention relates to immunogenic compositions comprising one or more Streptococcus pneumoniae capsular saccharide conjugates and a protein component comprising Protein E and/or PilA from Haemophilus influenzae.

First claim

We claim:

1. An immunogenic composition comprising: (i) 1 or more Streptococcus pneumoniae capsular saccharide conjugates; and (ii) a fusion protein component comprising (a) an immunogenic fragment of Protein E wherein the amino acid sequence of the immunogenic fragment of Protein E has a sequence that is SEQ ID NO. 124 or SEQ ID NO. 125, and (b) an immunogenic fragment of PilA from Haemophilus influenzae , wherein the amino acid sequence of the immunogenic fragment of PilA has at least 95%, identity, over the entire length, to SEQ ID NO. 127, wherein the immunogenic fragment of protein E is covalently linked to immunogenic fragment of PilA to form the fusion protein.

2. The immunogenic composition of claim 1 wherein the immunogenic fragment of Protein E is a polypeptide having an amino acid sequence of SEQ ID NO. 124.

3. The immunogenic composition of claim 1 wherein the immunogenic fragment of Protein E is a polypeptide having the amino acid sequence of SEQ ID NO. 125.

4. The immunogenic composition of claim 1 wherein the immunogenic fragment of PilA is a polypeptide comprising a sequence having at least 98% identity, over the entire length, to SEQ ID NO. 127.

5. The immunogenic composition of claim 1 wherein the immunogenic fragment of PilA is a polypeptide having an amino acid sequence that is SEQ ID NO. 127.

6. The immunogenic composition of claim 1 wherein the fusion protein is at least 95%, identical to SEQ ID NO. 194.

7. The immunogenic composition of claim 1 wherein the 1 or more Streptococcus pneumoniae capsular saccharide conjugates comprises a conjugated saccharide selected from the group consisting of a Streptococcus pneumoniae serotype 1, serotype 4, serotype 5, serotype 6B, serotype 9V, a serotype 14, a serotype 18C, a serotype 19F and a serotype 23F capsular saccharide conjugate.

8. The immunogenic composition of claim 1 or claim 7 wherein the 1 or more Streptococcus pneumoniae capsular saccharide conjugates comprises a conjugated saccharide selected from the group consisting of a conjugated serotype 1 saccharide, a conjugated serotype 5 saccharide and a conjugated serotype 7F saccharide.

9. The immunogenic composition of claim 1 or claim 7 wherein the 1 or more Streptococcus pneumoniae capsular saccharide conjugates are conjugated to a carrier protein independently selected from the group consisting of tetanus toxoid (TT), fragment C of TT, diphtheria toxoid, CRM197 (cross reacting material 197), Pneumolysin, protein D (from H. influenzae ), PhtD (Poly Histidine Triad D), PhtDE (a fusion between Pneumococal Histidine Triad D and E) and N19.

10. The immunogenic composition of claim 1 or claim 7 wherein the Streptococcus pneumoniae capsular saccharide conjugates are all independently conjugated to CRM197.

11. The immunogenic composition of claim 1 or claim 7 wherein the 1 or more Streptococcus pneumoniae capsular saccharide conjugates comprises a serotype 1 saccharide conjugated to protein D, a serotype 4 saccharide conjugated to protein D, a serotype 5 saccharide conjugated to protein D, a serotype 6B saccharide conjugated to protein D, a serotype 7F saccharide conjugated to protein D, a serotype 9V saccharide conjugated to protein D, a serotype 14 saccharide conjugated to protein D, a serotype 23F saccharide conjugated to protein D, a serotype 18C saccharide conjugated to tetanus toxoid and a serotype 19F saccharide conjugated to diphtheria toxoid.

12. The immunogenic composition of claim 1 wherein the immunogenic composition further comprises at least one unconjugated or conjugated Streptococcus pneumoniae protein.

13. The immunogenic composition of claim 12 wherein the at least one unconjugated or conjugated Streptococcus pneumoniae protein is a PhtD protein.

14. The immunogenic composition of claim 12 wherein the at least one unconjugated or conjugated Streptococcus pneumoniae protein is detoxified pneumolysin (dPly).

15. A vaccine comprising the immunogenic composition of claim 1 or claim 7 and a pharmaceutically acceptable excipient.

16. A method of immunizing a subject against diseases caused by Streptococcus pneumoniae infection comprising administering to the subject a therapeutically effective dose of the immunogenic composition of claim 1 or claim 7 or the vaccine of claim 15 .

17. A method of immunizing a subject against diseases caused by Haemophilus influenzae infection comprising administering to the subject a therapeutically effective dose of the immunogenic composition of claim 1 or claim 7 or the vaccine of claim 15 .

18. An immunogenic composition comprising a fusion protein wherein the amino acid sequence of the fusion protein is SEQ ID NO. 219.

19. An immunogenic composition comprising a fusion protein wherein the amino acid sequence of the fusion protein is SEQ ID NO. 177.

Assignees

• Glaxosmithkline Biologicals Sa
• Glaxosmithkline Biologicals Sa

Inventors

• Ceddia Francesca
• Hausdorff William Paul
• Verlant Vincent
• Ysebaert Carine

Classifications

• A61K39/102

  {Pasteurellales, e.g. Actinobacillus}, Pasteurella; Haemophilus · CPC title

• A61K39/092 Primary

  Streptococcus · CPC title

• A61K2039/55566

  Emulsions, e.g. Freund's adjuvant, MF59 · CPC title

• A61K2039/70

  Multivalent vaccine · CPC title

• A61K2039/6068

  Other bacterial proteins, e.g. OMP · CPC title