# US 10,478,487 B2 · Foot-and-mouth disease vaccine

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- Number: US 10,478,487 B2
- Document ID: US10478487B2
- Status: Granted
- Kind: B2
- Application number: 15/543,630
- Filed: 2016-01-15
- Published: 2018-09-20
- Granted: 2019-11-19
- Earliest claimed: 2015-01-16
- Assignees: Zoetis Services LLC; The United States of America as represented by the Secretary of Agriculture
- Applicants: Zoetis Services LLC; United States of America, as Represented by the Secretary of Agriculture
- Inventors: Paul Joseph Dominowski; John Morgan Hardham; James Alan Jackson; Cyril Gerard Gay; Luis Leandro Rodriguez; Peter William Krug; Aida Elizabeth Rieder
- Web page: https://patentgrep.com/patent/US10478487B2

## CPC

- A61K 39/135: Foot- and mouth-disease virus
- A61K 39/12: Viral antigens
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61P 31/12: Antivirals
- A61P 31/14: for RNA viruses
- A61P 37/04: Immunostimulants
- A61K 2039/5252: {inactivated (killed)}
- A61K 2039/552: {Veterinary vaccine}
- A61K 2039/555: {characterised by a specific combination antigen/adjuvant}
- A61K 2039/55505: {Inorganic adjuvants}
- A61K 2039/55511: {Organic adjuvants}
- A61K 2039/55561: {CpG containing adjuvants; Oligonucleotide containing adjuvants}
- A61K 2039/55566: {Emulsions, e.g. Freund's adjuvant, MF59}
- A61K 2039/55583: {Polysaccharides}
- C12N 2770/32034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2770/32134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- 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)

## Abstract

Compositions for prevention of Foot and Mouth Disease (FM D) are provided, comprising an antigen component in the amount equivalent to 0.5-20 μg FM D virus and an adjuvant component comprising oil, an immunostimulatory oligonucleotide, and a polycationic carrier. Methods of using the composition, as well as the methods of reducing FM D persistence are also provided.

## Claims

### Claim 1

A method of herd management, comprising administering to each member in said herd the immunogenic composition wherein said composition comprises:
a) antigen component comprising between about 8 μg and 10 μg of FMD (Foot-and-Mouth Disease) virus composition per dose;
b) an emulsion containing an oil;
c) 75-200 μg of a CpG-containing immunostimulatory oligonucleotide per dose;
d) 75-200 mg of a polycationic carrier per dose, and
wherein further, upon suspected contact with FMD infection, the vaccinated members of said herd are not slaughtered.

### Claim 2

A method of herd management, comprising administering to each member in said herd the immunogenic composition wherein said composition comprises:
a) antigen component comprising between about 8 μg and 10 μg of FMD (Foot-and-Mouth Disease) virus composition per dose;
b) an emulsion containing an oil;
c) 75-200 μg of a CpG-containing immunostimulatory oligonucleotide per dose;
d) 75-200 mg of a polycationic carrier per dose, and
wherein further, upon suspected contact with FMD infection, the vaccinated members of said herd are quarantined for 0-30 days.

### Claim 3

A method of herd management, comprising administering to each member in said herd the immunogenic composition wherein said composition comprises:
a) antigen component comprising between about 8 μg and 10 μg of FMD (Foot-and-Mouth Disease) virus composition per dose;
b) an emulsion containing an oil;
c) 75-200 μg of a CpG-containing immunostimulatory oligonucleotide per dose;
d) 75-200 mg of a polycationic carrier per dose, and
wherein further, upon suspected contact with FMD infection, the vaccinated members of said herd are moved beyond the infected premises.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the vaccinated members of the herd are not slaughtered and are quarantined for 0-30 days.

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

The method according to any one of claims 1-3, wherein the FMD virus composition is prepared by hollow fiber filtration.

### Claim 6 (depends on 1, 2, 3)

The method according to any one of claims 1-3, wherein the polycationic polymer is diethylaminoethyl (DEAE) Dextran.

### Claim 7 (depends on 6)

The method according to claim 6, wherein the immunostimulatory oligonucleotide comprises CpG.

### Claim 8 (depends on 7)

The method according to claim 7, wherein the immunostimulatory oligonucleotide comprises at least 15 contiguous nucleotides of SEQ ID NO: 8.

### Claim 9 (depends on 8)

The method according to claim 8, wherein the FMD virus composition comprises a DIVA (differentiating infected from vaccinated animals) marker.

### Claim 10 (depends on 9)

The method according to claim 9, wherein said DIVA marker comprises at least one of a mutated 3B or a mutated 3D protein.

### Claim 11 (depends on 10)

The method according to claim 10, wherein the oil is a light mineral oil.

### Claim 12 (depends on 11)

The method according to claim 11, wherein oily phase comprises 50.01%-55% v/v of the composition.

### Claim 13 (depends on 1, 2, 3)

The method according to any one of claims 1-3, wherein the FMD virus composition comprises a DIVA marker.

### Claim 14 (depends on 13)

The method according to claim 13, wherein said DIV marker comprises at least one of a mutated 3B or a mutated 3D protein.

### Claim 15 (depends on 14)

The method according to claim 14, wherein said FMD virus composition is a preparation of FMD virus Cruzeiro strain.

### Claim 16 (depends on 15)

The method according to claim 15, wherein said FMD virus Cruzeiro strain comprises a heterologous capsid protein.

### Claim 17 (depends on 16)

The method according to claim 16, wherein said heterologous capsid protein is from a strain selected from Asia1, Turkey06, O1Campos, C3Indaial, and A2001-Argentina.

### Claim 18 (depends on 16)

The method according to claim 16, wherein the polycationic polymer is diethylaminoethyl (DEAE) Dextran.

### Claim 19 (depends on 18)

The method according to claim 18, wherein the immunostimulatory oligonucleotide comprises CpG.

### Claim 20 (depends on 19)

The method according to claim 19, wherein the immunostimulatory oligonucleotide comprises at least 15 contiguous nucleotides of SEQ ID NO: 8.

### Claim 21 (depends on 20)

The method according to claim 20, wherein the oil is a light mineral oil.

### Claim 22 (depends on 21)

The method according to claim 21, wherein oily phase comprises 50.01%-55% v/v of the composition.
