# US 10,478,483 B2 · Combinations of meningococcal factor H binding proteins

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- Number: US 10,478,483 B2
- Document ID: US10478483B2
- Status: Granted
- Kind: B2
- Application number: 13/806,743
- Filed: 2011-06-24
- Published: 2013-07-25
- Granted: 2019-11-19
- Earliest claimed: 2010-06-25
- Assignees: Glaxosmithkline Biologicals SA
- Applicants: Maria Aricò; Brunella Brunelli; Maurizio Comanducci; Mariagrazia Pizza; Silvana Savino; Maria Scarselli
- Inventors: Maria Aricò; Brunella Brunelli; Maurizio Comanducci; Mariagrazia Pizza; Silvana Savino; Maria Scarselli
- Web page: https://patentgrep.com/patent/US10478483B2

## CPC

- A61K 39/095: Neisseria
- A61K 39/385: Haptens or antigens, bound to carriers
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61P 31/04: Antibacterial agents
- A61K 2039/55505: {Inorganic adjuvants}
- 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

The M01573 sequence of meningococcal fHbp offers poor coverage in a vaccine. The invention addresses this poor coverage in two ways. In a first aspect, a fHbp-based vaccine includes two family I fHbp sequences, one which is more closely related to MC58 than to M01573, and vice versa. In a second aspect, a multi-family fHbp-based vaccine uses a family I fHbp sequence which is more closely related to MC58 than to M01573, in combination with a family III fHbp sequence.

## Claims

### Claim 1

An immunogenic composition which comprises an immunologically effective amount of an adjuvant, an immunologically effective amount of a first isolated factor H binding protein (fHbp) antigen and an immunologically effective amount of a second isolated fHbp antigen, wherein: the first isolated fHbp antigen comprises a first amino acid sequence which has at least 75% sequence identity to both of SEQ ID NO: 1 and SEQ ID NO: 23, but the first amino acid sequence has a higher sequence identity to SEQ ID NO: 1 than to SEQ ID NO: 23, when aligned using the same algorithm and parameters; and the second isolated fHbp antigen comprises a second amino acid sequence which has at least 75% sequence identity to both of SEQ ID NO: 1 and SEQ ID NO: 23, but the second amino acid sequence has a higher sequence identity to SEQ ID NO: 23 than to SEQ ID NO: 1, when aligned using the same algorithm and parameters.

### Claim 2

An immunogenic composition which comprises an immunologically effective amount of an adjuvant, an immunologically effective amount of a first isolated fHbp antigen and an immunologically effective amount of a second isolated fHbp antigen, wherein: the first isolated fHbp antigen comprises a first amino acid sequence which has at least 75% sequence identity to both of SEQ ID NO: 1 and SEQ ID NO: 23, but the first amino acid sequence has a higher sequence identity to SEQ ID NO: 1 than to SEQ ID NO: 23, when aligned using the same algorithm and parameters; and the second isolated fHbp antigen comprises a second amino acid sequence (i) having at least 94% sequence identity to SEQ ID NO: 25 and/or (ii) consisting of a fragment of at least 50 contiguous amino acids from SEQ ID NO: 25.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the first isolated fHbp antigen can elicit antibodies in a mouse which are bactericidal against strain MC58 in a serum bactericidal assay.

### Claim 4 (depends on 2)

The composition of claim 2, wherein the first isolated fHbp antigen can elicit antibodies in a mouse which are bactericidal against strain MC58 in a serum bactericidal assay.

### Claim 5 (depends on 2)

The composition of claim 2, wherein the second isolated fHbp antigen can elicit antibodies in a mouse which are bactericidal against strain 961-5945 in a serum bactericidal assay.

### Claim 6 (depends on 1)

The composition of claim 1, wherein the second isolated fHbp antigen elicits antibodies in a mouse which are not bactericidal against strain MC58 in a serum bactericidal assay.

### Claim 7 (depends on 1)

The composition of claim 1, including a third isolated fHbp antigen comprising an amino acid sequence (i) having at least 94% sequence identity to SEQ ID NO: 25 and/or (ii) consisting of a fragment of at least 50 contiguous amino acids from SEQ ID NO: 25.

### Claim 8 (depends on 7)

The composition of claim 7, wherein the third isolated fHbp antigen can elicit antibodies in a mouse which are bactericidal against strain 961-5945 in a serum bactericidal assay.

### Claim 9 (depends on 2)

The composition of claim 2, wherein the composition does not include (i) an antigen comprising an amino acid sequence which has >95% sequence identity to SEQ ID NO: 23 or (ii) an antigen comprising an amino acid sequence which has >95% sequence identity to SEQ ID NO: 24.

### Claim 10 (depends on 1)

The composition of claim 1, wherein the adjuvant includes an aluminium salt.