Pneumococcal vaccine and uses thereof

Abstract

The present invention relates to new pneumococcal vaccines. The invention also relates to vaccination of subjects, in particular immunocompromised subjects, against pneumococcal infections using said novel pneumococcal vaccines.

1 . A pneumococcal vaccine comprising at least one conjugated capsular saccharide pneumococcal antigen and at least one TLR-9 agonist as an adjuvant. 
     
     
         2 . The pneumococcal vaccine of  claim 1  wherein said at least one TLR-9 agonist comprises a CpG Oligonucleotide. 
     
     
         3 . The pneumococcal vaccine of  claim 2  wherein said CpG oligonucleotide is a A, B, C or P class CpG immunostimulatory oligonucleotide. 
     
     
         4 - 13 . (canceled) 
     
     
         14 . The pneumococcal vaccine of  claim 2  wherein an internucleotide linkage of the CpG oligonucleotide is phosphodiester, phosphorothioate, methylphosphonate, methylphosphorothioate, phosphorodithioate, p-ethoxy, or combinations thereof. 
     
     
         15 . The pneumococcal vaccine of  claim 2 , wherein the CpG oligonucleotide is 6 to 100 nucleotides long. 
     
     
         16 . The pneumococcal vaccine of  claim 2  comprising from 0.2 mg to 10 mg of the CpG oligonucleotide. 
     
     
         17 . The pneumococcal vaccine of  claim 1 , wherein the conjugated capsular saccharide pneumococcal antigens are derived from at least seven serotypes of  S. pneumoniae.    
     
     
         18 - 19 . (canceled) 
     
     
         20 . The pneumococcal vaccine of  claim 1 , wherein said capsular saccharide antigens are individually conjugated to a carrier protein. 
     
     
         21 . The pneumococcal vaccine of  claim 17 , wherein the vaccine comprises conjugated  S. pneumoniae  saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F and 23F. 
     
     
         22 . The pneumococcal vaccine of  claim 21 , wherein the vaccine further comprises a conjugated  S. pneumoniae  saccharide from serotype 1. 
     
     
         23 . The pneumococcal vaccine of  claim 21 , wherein the vaccine further comprises a conjugated  S. pneumoniae  saccharide from serotype 5. 
     
     
         24 . The pneumococcal vaccine of  claim 21 , wherein the vaccine further comprises a conjugated  S. pneumoniae  saccharide from serotype 7F. 
     
     
         25 . The pneumococcal vaccine of  claim 21 , wherein the vaccine further comprises a conjugated  S. pneumoniae  saccharide from serotype 3. 
     
     
         26 . The pneumococcal vaccine of  claim 21 , wherein the vaccine further comprises a conjugated  S. pneumoniae  saccharide from serotype 6A. 
     
     
         27 . The pneumococcal vaccine of  claim 21 , wherein the vaccine further comprises a conjugated  S. pneumoniae  saccharide from serotype 19A. 
     
     
         28 . The pneumococcal vaccine of  claim 21 , wherein the vaccine further comprises a conjugated  S. pneumoniae  saccharide from serotype 22F. 
     
     
         29 . The pneumococcal vaccine of  claim 21 , wherein the vaccine further comprises a conjugated  S. pneumoniae  saccharide from serotype 15. 
     
     
         30 . The pneumococcal vaccine of  claim 21 , wherein the vaccine further comprises a conjugated  S. pneumoniae  saccharide from serotype 8. 
     
     
         31 . The pneumococcal vaccine of  claim 21 , wherein the vaccine further comprises a conjugated  S. pneumoniae  saccharide from serotype 12F. 
     
     
         32 . The pneumococcal vaccine of  claim 21 , wherein the vaccine further comprises a conjugated  S. pneumoniae  saccharide from serotype 2. 
     
     
         33 . The pneumococcal vaccine of  claim 21 , wherein the vaccine further comprises a conjugated  S. pneumoniae  saccharide from serotype 9N. 
     
     
         34 . The pneumococcal vaccine of  claim 21 , wherein the vaccine further comprises a conjugated  S. pneumoniae  saccharide from serotype 10A. 
     
     
         35 . The pneumococcal vaccine of  claim 21 , wherein the vaccine further comprises a conjugated  S. pneumoniae  saccharide from serotype 11A. 
     
     
         36 . The pneumococcal vaccine of  claim 21 , wherein the vaccine further comprises a conjugated  S. pneumoniae  saccharide from serotype 17F. 
     
     
         37 . The pneumococcal vaccine of  claim 21 , wherein the vaccine further comprises a conjugated  S. pneumoniae  saccharide from serotype 20. 
     
     
         38 . The pneumococcal vaccine of  claim 21 , wherein the vaccine further comprises a conjugated  S. pneumoniae  saccharide from serotype 33F. 
     
     
         39 . (canceled) 
     
     
         40 . The pneumococcal vaccine of  claim 17 , wherein the vaccine comprises conjugated  S. pneumoniae  saccharides from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. 
     
     
         41 . The pneumococcal vaccine of  claim 17 , wherein the vaccine comprises conjugated  S. pneumoniae  saccharides from serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. 
     
     
         42 . The pneumococcal vaccine of  claim 17 , wherein the vaccine comprises  S. pneumoniae  saccharides from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. 
     
     
         43 . The pneumococcal vaccine of  claim 1 , wherein the capsular saccharide antigens are conjugated to a carrier protein selected from the group consisting of: TT, DT, CRM197, fragment C of TT, PhtD, PhtDE fusions, detoxified pneumolysin, and protein D. 
     
     
         44 . The pneumococcal vaccine of  claim 1 , wherein the capsular saccharide antigens are all individually conjugated to the same carrier protein. 
     
     
         45 - 48 . (canceled) 
     
     
         49 . The pneumococcal vaccine of  claim 43 , wherein the carrier protein is CRM197. 
     
     
         55 . (canceled) 
     
     
         56 . The pneumococcal vaccine of  claim 21 , wherein the saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F and 23F are individually conjugated to protein D. 
     
     
         57 . The pneumococcal vaccine of  claim 21 , wherein the saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F and 23F are individually conjugated to CRM197. 
     
     
         58 . The pneumococcal vaccine of  claim 40 , wherein the saccharides from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F are individually conjugated to protein D. 
     
     
         59 . The pneumococcal vaccine of  claim 40 , wherein the saccharides serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F are individually conjugated to CRM197. 
     
     
         60 . The pneumococcal vaccine of  claim 41 , wherein the saccharides from serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F are individually conjugated to protein D. 
     
     
         61 . The pneumococcal vaccine of  claim 41 , wherein the saccharides from serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F are individually conjugated to CRM197. 
     
     
         62 . The pneumococcal vaccine of  claim 42 , wherein the saccharides from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F are individually conjugated to protein D. 
     
     
         63 . The pneumococcal vaccine of  claim 42 , wherein the saccharides from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F are individually conjugated to CRM197. 
     
     
         64 . The pneumococcal vaccine of  claim 135 , wherein the saccharides from serotype 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F individually conjugated to protein D. 
     
     
         65 . The pneumococcal vaccine of  claim 135 , wherein the saccharides from serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F individually conjugated to CRM197. 
     
     
         66 . The pneumococcal vaccine of  claim 41 , wherein the saccharides from serotypes 1, 4, 5, 6B, 7F, 9V, 14, and 23F individually conjugated to protein D, saccharide from serotype 18C conjugated to tetanus toxoid (TT) and saccharide from serotype 19F conjugated to diphtheria toxoid (DT). 
     
     
         67 . The pneumococcal vaccine of  claim 42 , wherein the saccharides from serotypes 1, 4, 5, 7F, 9V, 19F and 23F individually conjugated to tetanus toxoid (TT) and saccharide from serotypes 3, 14 18C and 6B individually conjugated to diphtheria toxoid (DT). 
     
     
         68 - 78 . (canceled) 
     
     
         79 . The pneumococcal vaccine of  claim 49 , wherein the vaccine comprises from 5 to 500 μg, 10 to 200 μg, or 20 to 100 μg of CRM197 carrier protein. 
     
     
         80 - 81 . (canceled) 
     
     
         82 . The pneumococcal vaccine of  claim 1 , wherein the vaccine comprises sodium chloride, sodium succinate buffer, or a combination thereof as excipients. 
     
     
         83 . The pneumococcal vaccine of  claim 1 , wherein the vaccine further comprises at least one additional adjuvant. 
     
     
         84 . (canceled) 
     
     
         85 . The pneumococcal vaccine of  claim 83 , wherein the additional adjuvant is alum, aluminium hydroxide, aluminum phosphate, or aluminum sulphate. 
     
     
         86 - 98 . (canceled) 
     
     
         99 . A method of immunizing a subject against diseases caused by  S. pneumoniae  infection comprising administering to said subject an immunoprotective dose of a vaccine according  claim 1 . 
     
     
         100 . A method of immunizing an immunocompromised subject against diseases caused by  S. pneumoniae  infection comprising administering to said subject an immunoprotective dose of a vaccine according  claim 1 . 
     
     
         101 . The method of  claim 100 , wherein said immunocompromised subject is a mammal. 
     
     
         102 . The method of  claim 101 , wherein said mammal is a cat, sheep, pig, horse, bovine, dog, rat, mouse or a human. 
     
     
         103 . (canceled) 
     
     
         104 . The method of  claim 100 , wherein said immunocompromised subject suffers from a disease that affects the immune system. 
     
     
         105 - 106 . (canceled) 
     
     
         107 . The method of  claim 104 , wherein said disease is selected from the group consisting of: bacterial infections, viral infections, cancers, aging, malnutrition, and chemotherapy drug treatments. 
     
     
         108 . The method of  claim 104 , wherein said disease is selected from the group consisting of: HIV-infection, acquired immunodeficiency syndrome (AIDS), cancer, chronic heart disorders, chronic lung disorders, congestive heart failure, diabetes mellitus, chronic liver disease, alcoholism, cirrhosis, spinal fluid leaks, cardiomyopathy, chronic bronchitis, emphysema, Chronic obstructive pulmonary disease (COPD), spleen dysfunction, lack of spleen function (asplenia), blood malignancy, leukemia, multiple myeloma, Hodgkin's disease, lymphoma, kidney failure, nephrotic syndrome, and asthma. 
     
     
         109 - 119 . (canceled) 
     
     
         120 . The method according to  claim 100 , wherein the immunocompromised subject is a human adult at least 55 years of age. 
     
     
         121 - 134 . (canceled) 
     
     
         135 . The pneumococcal vaccine of  claim 17 , wherein the vaccine comprises  S. pneumoniae  saccharides from serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F.