# US 8,784,826 B2 · Multiple vaccination including serogroup C meningococcus

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 8,784,826 B2
- Document ID: US8784826B2
- Status: Granted
- Kind: B2
- Application number: 13/603,278
- Filed: 2012-09-04
- Published: 2013-01-03
- Granted: 2014-07-22
- Earliest claimed: 2005-09-01
- Assignees: Novartis AG
- Applicants: Astrid Borkowski
- Inventors: Astrid Borkowski
- Web page: https://patentgrep.com/patent/US8784826B2

## CPC

- A61K 39/102: {Pasteurellales, e.g. Actinobacillus}, Pasteurella; Haemophilus
- A61K 39/0018: {Combination vaccines based on acellular diphtheria-tetanus-pertussis}
- A61K 39/05: {Actinobacteria, e.g. Actinomyces, Streptomyces, Nocardia, Bifidobacterium, Gardnerella}, Corynebacterium; Propionibacterium {(Mycobacterium A61K39/04)}
- A61K 39/08: Clostridium, e.g. Clostridium tetani
- A61K 39/092: {Streptococcus}
- A61K 39/095: Neisseria
- A61K 39/099: {Bordetella}
- A61P 31/04: Antibacterial agents
- A61P 31/06: for tuberculosis
- A61P 31/12: Antivirals
- A61P 31/14: for RNA viruses
- A61P 31/20: for DNA viruses
- A61P 37/04: Immunostimulants
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/55: {characterised by the host/recipient, e.g. newborn with maternal antibodies}
- A61K 2039/70: {Multivalent vaccine}
- C12N 2730/10134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2770/32634: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Various improvements to vaccines that include a serogroup C meningococcal conjugate antigen, including: (a) co-administration with acellular B. pertussis antigen; (b) co-administration with an inactivated poliovirus antigen; (c) supply in a kit together with a separate pneumococcal conjugate component, which may be in a liquid form; and (d) use in combination with a pneumococcal conjugate antigen but without an aluminum phosphate adjuvant. A kit may have: (a) a first immunogenic component that comprises an aqueous formulation of a conjugated capsular saccharide from Streptococcus pneumoniae; and (b) a second immunogenic component that comprises a conjugated capsular saccharide from Neisseria meningitidis serogroup C.

## Claims

### Claim 1

A kit, comprising a first immunogenic component and a second immunogenic component, wherein: (a) the first immunogenic component comprises a conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C; and (b) the second immunogenic component comprises an acellular Bordetella pertussis antigen and an inactivated poliovirus antigen; wherein the kit does not comprise a lyophilized conjugated H. influenzae type b antigen.

### Claim 2 (depends on 1)

The kit of claim 1, wherein the OAc+ strain is of serotype 16.

### Claim 3 (depends on 1)

The kit of claim 1, wherein the OAc+ strain is of serosubtype P1.7a,1 or serosubtype P1.1.

### Claim 4 (depends on 1)

The kit of claim 1, wherein the OAc+ strain is C11.

### Claim 5 (depends on 1, 2, 3, 4)

The kit of any one of claims 1 to 4, wherein the capsular saccharide from OAc+ strain of Neisseria meningitidis serogroup C is conjugated to a CRM197 carrier protein, a tetanus toxoid carrier protein, a diphtheria toxoid carrier protein or a Haemophilus influenzae protein D carrier protein.

### Claim 6 (depends on 1)

The kit of claim 1, wherein the capsular saccharide from OAc+ strain of Neisseria meningitidis serogroup C is a full length saccharide.

### Claim 7 (depends on 1)

The kit of claim 1, wherein the capsular saccharide from OAc+ strain of Neisseria meningitidis serogroup C is a fragment of a full length saccharide.

### Claim 8 (depends on 7)

The kit of claim 7, wherein the capsular saccharide has a molecular weight of <100 kDa.

### Claim 9 (depends on 7)

The kit of claim 7, wherein the capsular saccharide has a molecular weight of between 5 kDa-75 kDa.

### Claim 10 (depends on 1)

The kit of claim 1, wherein the capsular saccharide has a molecular weight of <100 kDa.

### Claim 11 (depends on 10)

The kit of claim 10, wherein the capsular saccharide has a molecular weight of between 5 kDa-75 kDa.

### Claim 12 (depends on 1)

The kit of claim 1, wherein the conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C conjugate has a saccharide:protein ratio (w/w) of between 1:10 and 10:1.

### Claim 13 (depends on 1)

The kit of claim 1, wherein the conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C conjugate is present at between 1 μg and 20 μg (measured as saccharide) per dose.

### Claim 14 (depends on 1)

The kit of claim 1, wherein the conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C is not adsorbed to an aluminium salt.

### Claim 15 (depends on 1)

The kit of claim 1, wherein the acellular Bordetella pertussis antigen comprises one, two or three of the following antigens: (1) detoxified pertussis toxin (PT); (2) filamentous hemagglutinin (FHA); (3) pertactin.

### Claim 16 (depends on 15)

The kit of claim 15, wherein PT, FHA and pertactin are adsorbed to aluminium hydroxide.

### Claim 17 (depends on 1)

The kit of claim 1, wherein the inactivated poliovirus antigen is from poliovirus Type 1, poliovirus Type 2 and poliovirus Type 3.

### Claim 18

A kit, comprising a first immunogenic component, a second immunogenic component and a third immunogenic component, wherein: (a) the first immunogenic component comprises a conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C; (b) the second immunogenic component comprises an acellular Bordetella pertussis antigen and/or an inactivated poliovirus antigen; and (c) the third immunogenic component comprises a conjugated capsular saccharide from Streptococcus pneumoniae; wherein the kit does not comprise a lyophilized conjugated H. influenzae type b antigen.

### Claim 19 (depends on 18)

The kit of claim 18, wherein the OAc+ strain is of serotype 16.

### Claim 20 (depends on 18)

The kit of claim 18, wherein the OAc+ strain is of serosubtype P1.7a,1 or serosubtype P1.1.

### Claim 21 (depends on 18)

The kit of claim 18, wherein the OAc+ strain is C11.

### Claim 22 (depends on 18, 19, 20, 21)

The kit of any one of claims 18 to 21, wherein the capsular saccharide from OAc+ strain of Neisseria meningitidis serogroup C is conjugated to a CRM197 carrier protein, a tetanus toxoid carrier protein, a diphtheria toxoid carrier protein or a Haemophilus influenzae protein D carrier protein.

### Claim 23 (depends on 18)

The kit of claim 18, wherein the capsular saccharide from OAc+ strain of Neisseria meningitidis serogroup C is a full length saccharide.

### Claim 24 (depends on 18)

The kit of claim 18, wherein the capsular saccharide from OAc+ strain of Neisseria meningitidis serogroup C is a fragment of a full length saccharide.

### Claim 25 (depends on 24)

The kit of claim 24, wherein the capsular saccharide has a molecular weight of <100 kDa.

### Claim 26 (depends on 24)

The kit of claim 24, wherein the capsular saccharide has a molecular weight of between 5 kDa-75 kDa.

### Claim 27 (depends on 18)

The kit of claim 18, wherein the capsular saccharide has a molecular weight of <100 kDa.

### Claim 28 (depends on 27)

The kit of claim 27, wherein the capsular saccharide has a molecular weight of between 5 kDa-75 kDa.

### Claim 29 (depends on 18)

The kit of claim 18, wherein the conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C conjugate has a saccharide:protein ratio (w/w) of between 1:10 and 10:1.

### Claim 30 (depends on 18)

The kit of claim 18, wherein the conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C conjugate is present at between 1 μg and 20 μg (measured as saccharide) per dose.

### Claim 31 (depends on 18)

The kit of claim 18, wherein the conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C is not adsorbed to an aluminium salt.

### Claim 32 (depends on 18)

The kit of claim 18, wherein the acellular Bordetella pertussis antigen comprises one, two or three of the following antigens: (1) detoxified pertussis toxin (PT); (2) filamentous hemagglutinin (FHA); (3) pertactin.

### Claim 33 (depends on 32)

The kit of claim 32, wherein PT, FHA and pertactin are adsorbed to aluminium hydroxide.

### Claim 34 (depends on 18)

The kit of claim 18, wherein the inactivated poliovirus antigen is from poliovirus Type 1, poliovirus Type 2 and poliovirus Type 3.

### Claim 35 (depends on 18)

The kit of claim 18, wherein the third immunogenic component comprises capsular saccharides from more than one serotype of Streptococcus pneumoniae.

### Claim 36 (depends on 18)

The kit of claim 18, wherein the third immunogenic component comprises capsular saccharides for at least Streptococcus pneumoniae serotypes 6B, 14, 19F and 23F.

### Claim 37 (depends on 35)

The kit of claim 35, wherein the Streptococcus pneumoniae are conjugated to a carrier protein selected from the group consisting of: CRM197, tetanus toxoid, diphtheria toxoid and Haemophilus influenzae protein D.

### Claim 38 (depends on 36)

The kit of claim 36, wherein the Streptococcus pneumoniae are conjugated to a carrier protein selected from the group consisting of: CRM197, tetanus toxoid, diphtheria toxoid and Haemophilus influenzae protein D.

### Claim 39 (depends on 35)

The kit of claim 35, wherein the conjugated capsular saccharides from Streptococcus pneumonia conjugate each have a saccharide:protein ratio (w/w) of between 1:10 and 10:1.

### Claim 40 (depends on 35)

The kit of claim 35, wherein the conjugated capsular saccharides from Streptococcus pneumoniae are each present at between 1 μg and 20 μg (measured as saccharide) per dose.

### Claim 41

An immunogenic composition comprising a conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C, an acellular Bordetella pertussis antigen and an inactivated poliovirus antigen; wherein the composition does not comprise a lyophilized conjugated H. influenzae type b antigen.

### Claim 42 (depends on 41)

The immunogenic composition of claim 41, wherein the OAc+ strain is of serotype 16.

### Claim 43 (depends on 41)

The immunogenic composition of claim 41, wherein the OAc+ strain is of serosubtype P1.7a,1 or serosubtype P1.1.

### Claim 44 (depends on 41)

The immunogenic composition of claim 41, wherein the OAc+ strain is C11.

### Claim 45 (depends on 41, 42, 43, 44)

The immunogenic composition of any one of claims 41 to 44, wherein the capsular saccharide from OAc+ strain of Neisseria meningitidis serogroup C is conjugated to a CRM197 carrier protein, a tetanus toxoid carrier protein, a diphtheria toxoid carrier protein or a Haemophilus influenzae protein D carrier protein.

### Claim 46 (depends on 41)

The immunogenic composition of claim 41, wherein the capsular saccharide from OAc+ strain of Neisseria meningitidis serogroup C is a full length saccharide.

### Claim 47 (depends on 41)

The immunogenic composition of claim 41, wherein the capsular saccharide from OAc+ strain of Neisseria meningitidis serogroup C is a fragment of a full length saccharide.

### Claim 48 (depends on 47)

The immunogenic composition of claim 47, wherein the capsular saccharide has a molecular weight of <100 kDa.

### Claim 49 (depends on 47)

The immunogenic composition of claim 47, wherein the capsular saccharide has a molecular weight of between 5 kDa-75 kDa.

### Claim 50 (depends on 41)

The immunogenic composition of claim 41, wherein the capsular saccharide has a molecular weight of <100 kDa.

### Claim 51 (depends on 50)

The immunogenic composition of claim 50, wherein the capsular saccharide has a molecular weight of between 5 kDa-75 kDa.

### Claim 52 (depends on 41)

The immunogenic composition of claim 41, wherein the conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C conjugate has a saccharide:protein ratio (w/w) of between 1:10 and 10:1.

### Claim 53 (depends on 41)

The immunogenic composition of claim 41, wherein the conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C conjugate is present at between 1 μg and 20 μg (measured as saccharide) per dose.

### Claim 54 (depends on 41)

The immunogenic composition of claim 41, wherein the conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C is not adsorbed to an aluminium salt.

### Claim 55 (depends on 41)

The immunogenic composition of claim 41, wherein the acellular Bordetella pertussis antigen comprises one, two or three of the following antigens: (1) detoxified pertussis toxin (PT); (2) filamentous hemagglutinin (FHA); (3) pertactin.

### Claim 56 (depends on 55)

The immunogenic composition of claim 55, wherein PT, FHA and pertactin are adsorbed to aluminium hydroxide.

### Claim 57 (depends on 41)

The immunogenic composition of claim 41, wherein the inactivated poliovirus antigen is from poliovirus Type 1, poliovirus Type 2 and poliovirus Type 3.