# US 10,245,311 B2 · Adjuvanting meningococcal factor H binding protein

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- Number: US 10,245,311 B2
- Document ID: US10245311B2
- Status: Granted
- Kind: B2
- Application number: 15/604,054
- Filed: 2017-05-24
- Published: 2017-12-21
- Granted: 2019-04-02
- Earliest claimed: 2009-03-24
- Assignees: Glaxosmithkline Biologicals SA
- Applicants: GlaxoSmithKline Biologicals SA
- Inventors: Mario Contorni; Lorenzo Tarli
- Web page: https://patentgrep.com/patent/US10245311B2

## CPC

- A61K 39/095: Neisseria
- A61K 47/02: Inorganic compounds
- A61P 31/04: Antibacterial agents
- A61P 37/04: Immunostimulants
- A61K 2039/55505: {Inorganic adjuvants}
- A61K 2039/55583: {Polysaccharides}
- A61K 2039/6018: {Lipids, e.g. in lipopeptides}
- A61K 2039/70: {Multivalent vaccine}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Factor H binding protein (fHBP) has been proposed for use in immunizing against serogroup B meningococcus (‘MenB’). This antigen can be efficiently adsorbed to an aluminum hydroxyphosphate adjuvant by (i) ensuring that adsorption takes place at a pH which is equal to or below the adjuvant's point of zero charge (PZC), and/or (ii) selecting a fHBP and adjuvant with an isoelectric point/PZC within the range of 5.0 to 7, and/or (iii) selecting a fHBP with an isoelectric point above the adjuvant's PZC and using a buffer to bring the pH to within 1.2 pH units of the PZC. The adsorption is particularly useful for compositions which include multiple fHBP variants, and also in situations where an aluminum hydroxide adjuvant should be avoided. Buffered pharmaceutical compositions can include at least two different meningococcal fHBP antigens, both of which are at least 85% adsorbed to aluminum hydroxyphosphate adjuvant.

## Claims

### Claim 1

A method for raising an immune response in a human comprising administering to the human a buffered immunogenic composition comprising at least two different meningococcal fHBP antigens, both of which are at least 85% adsorbed to aluminium hydroxyphosphate adjuvant.

### Claim 2

A method for raising an immune response in a human comprising administering to the human a buffered immunogenic composition comprising two different meningococcal fHBP antigens, both adsorbed to aluminium hydroxyphosphate adjuvant, wherein (i) each meningococcal fHBP antigen has 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.