# US 2014/0193451 A1 · Immunogenic composition

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- Number: US 2014/0193451 A1
- Document ID: US20140193451A1
- Status: Published application
- Kind: A1
- Application number: 13/826,932
- Filed: 2013-03-14
- Published: 2014-07-10
- Earliest claimed: 2012-10-17
- Assignees: Glaxosmithkline Biologicals SA
- Applicants: Glaxosmithkline Biologicals SA
- Inventors: VINCENT VERLANT
- Web page: https://patentgrep.com/patent/US20140193451A1

## CPC

- A61K 39/092: {Streptococcus}
- A61K 47/646: {the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines}
- 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)

## Abstract

The present invention relates to immunogenic compositions comprising 26 μg-45 μg of pneumolysin and/or PhtD, vaccines comprising the immunogenic compositions and their use in medicine.

## Claims

### Claim 1

An immunogenic composition comprising 26 μg-45 μg, 26 μg-40 μg, 28 μg-35 μg or around 30 μg of detoxified pneumolysin (dPly) and/or PhtD (polyhistidine triad family D), per human dose.

### Claim 2 (depends on 1)

The immunogenic composition of claim 1 wherein the pneumolysin has been chemically detoxified.

### Claim 3 (depends on 1)

The immunogenic composition of claim 1 wherein the pneumolysin has been genetically detoxified.

### Claim 4 (depends on 1, 2, 3)

The immunogenic composition of any one of claims 1-3 wherein the PhtD (poly histidine triad family D) comprises an amino acid sequence at least 85%, 90%, 95%, 98%, 99% or 100% identical to the sequence of amino acids 21-838 of Sequence ID No. 4 of WO00/37105.

### Claim at position 5

5-15. (canceled)

### Claim 16

The immunogenic composition of any preceding claim wherein the immunogenic composition does not comprise an oil in water adjuvant.

### Claim at position 7

17-19. (canceled)

### Claim 20

The immunogenic composition of any preceding claim wherein the immunogenic composition further comprises 1 or more (e.g. 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, or 23) Streptococcus pneumoniae capsular saccharide conjugates.

### Claim 21 (depends on 20)

The immunogenic composition of claim 20 wherein the 1 or more Streptococcus pneumoniae capsular saccharide conjugates comprises a conjugated serotype 4 saccharide, a conjugated serotype 6B saccharide, a conjugated serotype 9V saccharide, a conjugated serotype 14 saccharide, a conjugated serotype 18C saccharide, a conjugated serotype 19F saccharide and a conjugated serotype 23F saccharide.

### Claim 22 (depends on 20, 21)

The immunogenic composition of claim 20 or 21 wherein the 1 or more Streptococcus pneumoniae capsular saccharide conjugates comprises a conjugated serotype 1 saccharide, a conjugated serotype 5 saccharide and a conjugated serotype 7F saccharide.

### Claim at position 11

23-35. (canceled)

### Claim 36 (depends on 20, 21, 22)

The immunogenic composition of any one of claims 20-22 wherein the 1 or more Streptococcus pneumoniae capsular saccharide conjugates are conjugated to a carrier protein independently selected from the group consisting of tetanus toxoid (TT), fragment C of TT, diphtheria toxoid (DT), CRM197 (cross reacting material 197), detoxified pneumolysin, protein D from H. influenzae, PhtD (Poly Histidine Triad D), PhtDE (fusion protein between Poly Histidine Triad D and Poly Histidine Triad E) and N19.

### Claim 37 (depends on 20, 21, 22, 36)

The immunogenic composition of any one of claim 20-22 or 36 wherein the 1 or more Streptococcus pneumoniae capsular saccharide conjugates are all independently conjugated to CRM197.

### Claim at position 14

38-50. (canceled)

### Claim 51 (depends on 20, 21, 22, 36, 37)

The immunogenic composition of any one of claim 20-22 or 36-37 wherein the 1 or more Streptococcus pneumoniae capsular saccharide conjugates comprises a serotype 1 saccharide conjugated to protein D, a serotype 4 saccharide conjugated to protein D, a serotype 5 saccharide conjugated to protein D, a serotype 6B saccharide conjugated to protein D, a serotype 7F saccharide conjugated to protein D, a serotype 9V saccharide conjugated to protein D, a serotype 14 saccharide conjugated to protein D, a serotype 23F saccharide conjugated to protein D, a serotype 18C saccharide conjugated to tetanus toxoid and a serotype 19F saccharide conjugated to diphtheria toxoid.

### Claim at position 16

52-61. (canceled)

### Claim 62

The immunogenic composition of any preceding claim which further comprises an adjuvant.

### Claim 63 (depends on 62)

The immunogenic composition of claim 62 wherein the adjuvant is aluminium phosphate.

### Claim at position 19

64-65. (canceled)

### Claim 66

A vaccine comprising the immunogenic composition of any preceding claim and a pharmaceutically acceptable excipient.

### Claim 67 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 20, 21, 22, 36, 51, 62, 63, 64, 65, 66)

A method of immunising a human host against diseases caused by Streptococcus pneumoniae infection comprising administering to the host an immunoprotective dose of the immunogenic composition of any one of claims 1-9, 20-22, 36, 51, 62-65 or the vaccine of claim 66.

### Claim 68 (depends on 67)

The method of claim 67 wherein the host is selected from the group consisting of an adult human, and elderly human, an infant human and a toddler human.

### Claim at position 23

69-79. (canceled)
