Multivalent meningococcal polysaccharide-protein conjugate vaccine

Patent metadata

Field	Value
Publication number	US-9173955-B2
Application number	US-201514636870-A
Country	US
Kind code	B2
Filing date	Mar 3, 2015
Priority date	Jan 23, 2001
Publication date	Nov 3, 2015
Grant date	Nov 3, 2015

Abstract

The present invention describes a combined vaccine that offers broad protection against meningococcal disease caused by the pathogenic bacteria Neisseria meningitidis . The vaccine is comprised of four distinct polysaccharide-protein conjugates that are formulated as a single dose of vaccine. Purified capsular polysaccharides from Neisseria meningitidis serogroups A, C, W-135, and Y are chemically activated and selectively attached to a carrier protein by means of a covalent chemical bond, forming polysaccharide-protein conjugates capable of eliciting long-lasting immunity to a variety of N. meningitidis strains in children as well as adults.

First claim

I claim:

1. A method of vaccinating a human susceptible to infection due to Neisseria meningitidis comprising administering to the human an immunologically effective amount of an immunological composition comprising a mixture of four distinct and separately made protein-capsular polysaccharide conjugates, wherein the first conjugate comprises purified Neisseria meningitidis capsular polysaccharide of serogroup W-135 conjugated to a purified carrier protein, the second conjugate comprises purified N. meningitidis capsular polysaccharide of serogroup Y conjugated to a purified carrier protein, the third conjugate comprises purified N. meningitidis capsular polysaccharide of serogroup A conjugated to a purified carrier protein, and the fourth conjugate comprises purified N. meningitidis capsular polysaccharide of serogroup C conjugated to a purified carrier protein, wherein the immunological composition has the capacity to elicit in children less than two years of age a primary serum IgG response and a serum bactericidal antibody response to each of the N. meningitidis serogroups A, C, W-135 and Y capsular polysaccharides, wherein said serum bactericidal antibody response is higher than that elicited by the licensed, unconjugated, tetravalent A, C, W-135 and Y meningococcal capsular polysaccharide vaccine, and further wherein the immunological composition has the capacity to elicit a booster anamnestic IgG response to each of the N. meningitidis serogroups A, C, W-135and Y capsular polysaccharides.

2. The method of claim 1 , wherein the immunological composition further comprises an adjuvant.

3. The method of claim 2 , wherein the adjuvant is an aluminum adjuvant.

4. The method of claim 3 , wherein the adjuvant is aluminum hydroxide.

5. The method of claim 3 , wherein the adjuvant is aluminum phosphate.

6. The method of claim 1 , wherein said carrier protein is a single carrier protein species.

7. The method of claim 6 , wherein said single carrier protein species is selected from the group consisting of diphtheria toxoid, CRM 197 and tetanus toxoid.

8. The method of claim 7 , wherein said carrier protein species is diphtheria toxoid.

9. The method of claim 7 , wherein said carrier protein species is CRM 197 .

10. The method of claim 7 , wherein said carrier protein species is tetanus toxoid.

11. The method of claim 1 , wherein the immunological composition is formulated as a sterile liquid.

12. The method of claim 1 , wherein the immunological composition further comprises a pharmaceutically acceptable preservative.

13. The method of claim 12 , wherein said pharmaceutically acceptable preservative is thimerosal.

14. The method of claim 1 , wherein the method includes the administration of a primary dose and a booster dose of the immunological composition.

15. The method of claim 1 , wherein the immunological composition is formulated at 4 microgram of each of the N. meningitidis serogroups A, C, W-135 and Y capsular polysaccharides per dose of the composition.

16. The method of claim 1 , wherein the immunological composition is unadjuvanted.

17. A method of vaccinating a human susceptible to infection due to Neisseria meningitidis comprising administering to the human an immunologically effective amount of a tetravalent conjugate vaccine comprising a mixture of four distinct and separately made protein-capsular polysaccharide conjugates, wherein the first conjugate comprises purified Neisseria meningitidis capsular polysaccharide of serogroup W-135 conjugated to a purified carrier protein, the second conjugate comprises purified N. meningitidis capsular polysaccharide of serogroup Y conjugated to a purified carrier protein, the third conjugate comprises purified N. meningitidis capsular polysaccharide of serogroup A conjugated to a purified carrier protein, and the fourth conjugate comprises purified N. meningitidis capsular polysaccharide of serogroup C conjugated to a purified carrier protein, wherein the tetravalent conjugate vaccine has the capacity to elicit in children less than two years of age a primary serum IgG response and a serum bactericidal antibody response to each of the N. meningitidis serogroups A, C, W-135 and Y capsular polysaccharides, wherein said serum bactericidal antibody response is higher than that elicited by the licensed, unconjugated, tetravalent A, C, W-135 and Y meningococcal capsular polysaccharide vaccine, and further wherein the conjugate vaccine has the capacity to elicit a booster anamnestic IgG response to each of the N. meningitidis serogroups A, C, W-135and Y capsular polysaccharides.

18. The method of claim 17 , wherein the conjugate vaccine further comprises an adjuvant.

19. The method of claim 18 , wherein the adjuvant is an aluminum adjuvant.

20. The method of claim 19 , wherein the adjuvant is aluminum hydroxide.

21. The method of claim 19 , wherein the adjuvant is aluminum phosphate.

22. The method of claim 17 , wherein said carrier protein is a single carrier protein species.

23. The method of claim 22 , wherein said single carrier protein species is selected from the group consisting of diphtheria toxoid, CRM 197 and tetanus toxoid.

24. The method of claim 23 , wherein said carrier protein species is diphtheria toxoid.

25. The method of claim 23 , wherein said carrier protein species is CRM 197 .

26. The method of claim 23 , wherein said carrier protein species is tetanus toxoid.

27. The method of claim 17 , wherein the conjugate vaccine is formulated as a sterile liquid.

28. The method of claim 27 , wherein the conjugate vaccine further comprises a pharmaceutically acceptable preservative.

29. The method of claim 28 , wherein said pharmaceutically acceptable preservative is thimerosal.

30. The method of claim 17 , wherein the method includes the administration of a primary dose and a booster dose of the conjugate vaccine.

31. The method of claim 17 , wherein the conjugate vaccine is formulated at 4 microgram of each of the N. meningitidis serogroups A, C, W-135and Y capsular polysaccharides per dose of the composition.

32. The method of claim 17 , wherein the conjugate vaccine is unadjuvanted.

33. An immunological composition comprising a mixture of four distinct and separately made protein-capsular polysaccharide conjugates, wherein the first conjugate comprises purified Neisseria meningitidis capsular polysaccharide of serogroup W-135conjugated to a purified carrier protein, the second conjugate comprises purified N. meningitidis capsular polysaccharide of serogroup Y conjugated to a purified carrier protein, the third conjugate comprises purified N meningitidis capsular polysaccharide of serogroup A conjugated to a purified carrier protein, and the fourth conjugate comprises purified N. meningitidis capsular polysaccharide of serogroup C conjugated to a purified carrier protein, wherein the immunological composition has the capacity to elicit in children less than two years of age a primary serum IgG response and a serum bactericidal antibody response to each of the N. meningitidis serogroups A, C, W-135 and Y capsular polysaccharides, wherein said serum bactericidal antibody response is higher than that elicited by the licensed, unconjugated, tetravalent A, C, W-135 and Y meningococcal caps

Assignees

• Sanofi Pasteur Inc

Inventors

• Ryall Robert P

Classifications

• A61K47/6415 Primary

  Toxins or lectins, e.g. clostridial toxins or Pseudomonas exotoxins · CPC title

• A61K47/24

  containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids · CPC title

• A61K39/116

  Polyvalent bacterial antigens · CPC title

• A61K47/646

  the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines · CPC title

• A61P37/04

  Immunostimulants · CPC title