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Patexia Research
Patent No. US 08834888
Issue Date Sep 16, 2014
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Patent 08834888 - Adjuvanting meningococcal factor H binding protein > Claims

  • 1. An immunogenic composition comprising two different meningococcal factor H binding protein (fHBP) antigens, both of which are adsorbed to aluminium hydroxyphosphate adjuvant, wherein (i) both of the meningococcal fHBP antigens have an isoelectric point between 5.0 and 7.0, and (ii) the aluminium hydroxyphosphate adjuvant has a point of zero charge between 5.0 and 7.0, wherein at least 85% of the each of the fHBP antigens is adsorbed to the aluminium hydroxyphosphate adjuvant.
    • 2. The composition of claim 1, wherein (i) both of the meningococcal fHBP antigens have an isoelectric point which is greater than the adjuvant's point of zero charge and (ii) the composition has a pH which is within 1.2 pH units of the adjuvant's point of zero charge.
    • 3. The composition of claim 1, including a buffer to maintain pH in the range of 5.0 to 7.0.
      • 4. The composition of claim 3, including a histidine buffer.
    • 5. The composition of claim 1, wherein the immunogenic composition includes a buffer to maintain pH in the range of 5.0 to 6.0.
    • 6. The composition of claim 1, including a buffer which maintains the pH within 1.2 pH units of the adjuvant's point of zero charge.
    • 7. The composition of claim 1, including a buffer which maintains the pH within 0.5 pH unit of the adjuvant's point of zero charge.
    • 8. The composition of claim 1, wherein both of the meningococcal fHBP antigens have an isoelectric point between 5.0 and 6.0.
    • 9. The composition of claim 1, wherein both of the meningococcal fHBP antigens have an isoelectric point between 5.2 and 6.2.
    • 10. The composition of claim 1, wherein the aluminium hydroxyphosphate has a point of zero charge between 5.4 and 6.2.
    • 11. The composition of claim 1, wherein (i) both of the meningococcal fHBP antigens have an isoelectric point between 5.2 and 6.2 and (ii) the aluminium hydroxyphosphate has a point of zero charge between 5.0 and 6.0.
    • 12. The composition of claim 1, wherein the composition does not include an aluminium hydroxide adjuvant.
    • 13. The composition of claim 1, including a conjugated bacterial capsular saccharide.
      • 14. The composition of claim 13, including a pneumococcal capsular saccharide conjugated to a carrier protein.
        • 15. The composition of claim 14, including capsular saccharide from each of pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F.
          • 16. The composition of claim 15, including capsular saccharide from: (a) each of pneumococcal serotypes 1, 4, 5, 6B, 9V, 14, 18C, 19F and 23F; (b) each of pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F; (c) each of pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F; or (d) each of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19, 19F and 23F.
    • 17. The composition of claim 1, wherein the aluminium hydroxyphosphate has a P/Al molar ratio between 0.85 and 1.0.
    • 18. The composition of claim 1, wherein the aluminium hydroxyphosphate is amorphous and particulate comprising plates with diameters 10-100nm.
    • 19. The composition of claim 1, wherein the Al+++concentration is <2mg/ml.
      • 20. The composition of claim 19, wherein the Al+++concentration is between 0.2 and 1mg/ml.
    • 21. The composition of claim 1, wherein the composition includes NaCl.
      • 22. The composition of claim 21, wherein the concentration of NaCl is 10 ±2 mg/ml.
      • 23. The composition of claim 21, comprising polysorbate 80.
    • 24. The composition of claim 1, including between 1 and 500μg/dose of each fHbp antigen.
      • 25. The composition of claim 24, having 20, 40, 50, 60, 80, 100or 200μg of each fHBP antigen.
    • 26. The composition of claim 1, wherein the fHBP antigens are lipidated at a N terminus cysteine.
  • 27. An immunogenic composition comprising two different meningococcal factor H binding protein (fHBP) antigens, both of which are adsorbed to aluminium hydroxyphosphate adjuvant, wherein both of the meningococcal fHBP antigens have an isoelectric point between 5.0 and 7.0, wherein the two different meningococcal fHBP antigens are: (a) a first polypeptide comprising an amino acid sequence having at least 98% sequence identity to SEQ ID NO: 4; andn(b) a second polypeptide comprising an amino acid sequence having at least 98% sequence identity to SEQ ID NO: 6, and wherein the composition: (i) includes a histidine buffer to maintain a pH in the range of 5.0 to 7.0; (ii) has an Al+++ concentration <1 mg/ml; (iii) includes NaCl; (iv) includes polysorbate 80; and (v) includes between 1and 500μg/dose of each fHbp polypeptide.
    • 28. The composition of claim 27, wherein the first polypeptide has amino acid sequence SEQ ID NO: 23 and the second polypeptide has amino acid sequence SEQ ID NO: 25.
      • 33. The composition of claim 28, wherein at least one of the meningococcal fHBP antigens is lipidated at a N-terminus cysteine.
      • 34. The composition of claim 28, wherein both of the meningococcal fHBP antigens are lipidated at a N-terminus cysteine.
    • 29. The composition of claim 27, wherein the composition includes between 60 and 200μg/dose of each fHbp polypeptide.
    • 30. The composition of claim 27, wherein the composition includes 60μg/dose of each fHbp polypeptide.
    • 31. The composition of claim 27, wherein at least one of the meningococcal fHBP antigens is lipidated at a N-terminus cysteine.
    • 32. The composition of claim 27, wherein both of the meningococcal fHBP antigens are lipidated at a N-terminus cysteine.
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