# US 7,608,279 B2 · Vaccine formulations

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- Number: US 7,608,279 B2
- Document ID: US7608279B2
- Status: Granted
- Kind: B2
- Application number: 12/027,776
- Filed: 2008-02-07
- Published: 2008-08-07
- Granted: 2009-10-27
- Earliest claimed: 2003-07-24
- Assignees: Merial Limited
- Inventors: Alexis Guy Andre Parisot; Stephanie Marie-Catherine Desgouilles-Blechet; Catherine Charreyre
- Web page: https://patentgrep.com/patent/US7608279B2

## CPC

- A61K 39/12: Viral antigens
- A61K 39/0241: {Mollicutes, e.g. Mycoplasma, Erysipelothrix}
- A61K 39/102: {Pasteurellales, e.g. Actinobacillus}, Pasteurella; Haemophilus
- A61K 39/145: Orthomyxoviridae, e.g. influenza virus
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61P 31/08: for leprosy
- A61P 31/10: Antimycotics
- A61P 31/12: Antivirals
- A61P 33/00: Antiparasitic agents
- A61P 37/04: Immunostimulants
- A61K 2039/521: {inactivated (killed)}
- A61K 2039/5252: {inactivated (killed)}
- A61K 2039/55: {characterised by the host/recipient, e.g. newborn with maternal antibodies}
- A61K 2039/552: {Veterinary vaccine}
- A61K 2039/55566: {Emulsions, e.g. Freund's adjuvant, MF59}
- A61K 2039/70: {Multivalent vaccine}
- C12N 2750/10034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/16134: 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

The present invention provides for a novel oil-in-water (O/W) emulsion, with increased stability in the presence of bacterial or viral suspensions, especially those concentrated and non-purified or weakly purified. The emulsion of the present invention can act as vehicle for the delivery of a pharmaceutical composition comprising at least one immunogen and, in particular, an immunogen selected from the group comprising an inactivated pathogen, an attenuated pathogen, a subunit, a recombinant expression vector, and a plasmid or combinations thereof.

## Claims

### Claim 1

A vaccine composition comprising an injectable oil-in-water (O/W) emulsion, comprising:
(i) an aqueous solution containing at least one immunogen,
(ii) a paraffin oil,
(iii) a sorbitan monooleate,
(iv) an ethoxylated sorbitan trioleate and
(v) a non-ionic block copolymer.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the paraffin oil is present at a concentration of 10% to 40% v/v, the sorbitan monooleate is present at a concentration of 0.2% to 1.5% w/v, the ethoxylated sorbitan trioleate is present at a concentration of 2% to 5% w/v and the non-ionic block copolymer is present at a concentration of 0.1% to 0.5% w/v.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the paraffin oil is present at a concentration of 29.3% v/v, the sorbitan monooleate is present at a concentration of 0.6% w/v, the ethoxylated sorbitan trioleate is present at a concentration of 3.4% w/v and the non-ionic block copolymer is present at a concentration of 0.25% w/v.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the immunogen is selected from the group consisting of an inactivated pathogen, an attenuated pathogen, a subunit, a recombinant expression vector, and a plasmid or combinations thereof.

### Claim 5 (depends on 4)

The composition of claim 4, wherein the pathogen is selected from the group consisting of a virus, a bacterium, a fungus, protozoal parasite or combinations thereof or wherein the immunogen is an inactivated porcine circovirus type 2 (PCV-2) virus or an inactivated Mycoplasma hvopneumoniae bacterium or a combination thereof.

### Claim 6 (depends on 4)

A method for inducing an immunological response in an animal against a pathogen comprising administering to said animal a vaccine composition according to claim 4.

### Claim 7 (depends on 6)

A method according to claim 6, wherein the vaccine composition is administered in a single dose or wherein the animal is selected from the group consisting of cattle, pigs, horses, dogs, cats, chickens, ducks, and turkeys or wherein the vaccine composition is administered in a single dose and wherein the administration is intramuscular (IM), intradermal (ID) or subcutaneous (SC) injection or wherein the vaccine composition is administered in a single dose, wherein the administration is intramuscular (IM), intradermal (ID) or subcutaneous (SC) injection and wherein the administration is done with a needlefree injector.

### Claim 8 (depends on 1)

A method for inducing an immunological response in an animal against a pathogen comprising administering to said animal a vaccine composition according to claim 1.

### Claim 9 (depends on 1)

A method for inducing a gamma-interferon (IFNγ) response in an animal comprising administering to said animal a composition according to claim 1.

### Claim 10 (depends on 8)

A method according to claim 8, wherein the vaccine composition is administered in a single dose or wherein the animal is selected from the group consisting of cattle, pigs, horses, dogs, cats, chickens, ducks, and turkeys or wherein the vaccine composition is administered in a single dose and wherein the administration is intramuscular (IM), intradermal (ID) or subcutaneous (SC) injection or wherein the vaccine composition is administered in a single dose, wherein the administration is intramuscular (IM), intradermal (ID) or subcutaneous (SC) injection and wherein the administration is done with a needlefree injector.

### Claim 11 (depends on 9)

A method according to claim 9, wherein the vaccine composition is administered in a single dose or wherein the animal is selected from the group consisting of cattle, pigs, horses, dogs, cats, chickens, ducks, and turkeys or wherein the vaccine composition is administered in a single dose and wherein the administration is intramuscular (IM), intradermal (ID) or subcutaneous (SC) injection or wherein the vaccine composition is administered in a single dose, wherein the administration is intramuscular (IM), intradermal (ID) or subcutaneous (SC) injection and wherein the administration is done with a needlefree injector.

### Claim 12 (depends on 1)

A kit having at least 2 vials, comprising: an immunogen in a first vial and an emulsion according to claim 1 in a second vial.
