# US 10,117,921 B2 · Oil-based adjuvants

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- Number: US 10,117,921 B2
- Document ID: US10117921B2
- Status: Granted
- Kind: B2
- Application number: 14/491,414
- Filed: 2014-09-19
- Published: 2015-05-21
- Granted: 2018-11-06
- Earliest claimed: 2013-09-19
- Assignees: Zoetis Services LLC
- Applicants: Zoetis Services LLC
- Inventors: Paul Joseph Dominowski; Dennis L. Foss; Guillermo Gallo; John Morgan Hardham; Richard Lee Krebs; Sandra Ann Marie Lightle; Suman Mahan; Sangita Mediratta; Kaori Mohr; Duncan Mwangi; Sharath K. Rai; Sarah A. Salmon; Shaunak Vora; Lauren Wilmes
- Web page: https://patentgrep.com/patent/US10117921B2

## CPC

- A61K 39/092: {Streptococcus}
- A61K 39/0002: {Fungal antigens, e.g. Trichophyton, Aspergillus, Candida}
- A61K 39/0003: {Invertebrate antigens}
- A61K 39/0005: {Vertebrate antigens (from snakes A61K39/38)}
- A61K 39/002: Protozoa antigens
- A61K 39/012: Coccidia antigens
- A61K 39/0258: {Escherichia}
- 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 39/085: Staphylococcus
- A61K 39/118: Chlamydiaceae, e.g. Chlamydia trachomatis or Chlamydia psittaci
- A61K 39/12: Viral antigens
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 15/06: Antiabortive agents; Labour repressants
- A61P 31/04: Antibacterial agents
- A61P 31/10: Antimycotics
- A61P 31/12: Antivirals
- A61P 31/14: for RNA viruses
- A61P 33/02: Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
- A61P 33/14: Ectoparasiticides, e.g. scabicides
- A61P 37/02: Immunomodulators
- A61P 37/04: Immunostimulants
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- G01N 33/56944: {Streptococcus}
- A61K 2039/552: {Veterinary vaccine}
- A61K 2039/55561: {CpG containing adjuvants; Oligonucleotide containing adjuvants}
- A61K 2039/55566: {Emulsions, e.g. Freund's adjuvant, MF59}
- A61K 2039/55572: {Lipopolysaccharides; Lipid A; Monophosphoryl lipid A}
- A61K 2039/55577: {Saponins; Quil A; QS21; ISCOMS}
- A61K 2039/55583: {Polysaccharides}
- G01N 2333/315: from Streptococcus (G), e.g. Enterococci
- G01N 2469/10: Detection of antigens from microorganism in sample from host
- 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
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The instant invention provides various formulations comprising combinations of immunostimulating oligonucleotides, polycationic carriers, sterols, saponins, quaternary amines, TLR-3 agonists, glycolipids, and MPL-A or analogs thereof in oil emulsions, use thereof in preparations of immunogenic compositions and vaccines, and use thereof in the treatment of animals.

## Claims

### Claim 1

An immunogenic composition comprising an effective amount of a Foot-and-Mouth Disease Virus (FMDV) antigen and an adjuvant formulation comprising an oily phase and an aqueous phase, a polycationic carrier, and a CpG containing immunostimulatory oligonucleotide, wherein the vaccine is a water-in-oil emulsion.

### Claim 2 (depends on 1)

The immunogenic composition of claim 1 wherein the adjuvant formulation further comprises an aluminum hydroxide gel.

### Claim 3 (depends on 1)

The immunogenic composition of claim 1, wherein the polycationic carrier is DEAE dextran.

### Claim 4 (depends on 1)

The immunogenic composition of claim 1, wherein the Foot-and-Mouth Disease Virus antigen is genetically modified.

### Claim 5 (depends on 4)

The immunogenic composition of claim 4, wherein the Foot-and-Mouth Disease Virus antigen is a leaderless virus.

### Claim 6 (depends on 4)

The immunogenic composition of claim 4, wherein the Foot-and-Mouth Disease Virus antigen expresses one or more FMDV structural proteins of a serotype selected from the group consisting of A, C, O, Asia1, SAT1, SAT2, or SAT3.

### Claim 7 (depends on 6)

The immunogenic composition of claim 6, wherein the Foot-and-Mouth Disease virus antigen comprises antigens from multiple FMDV serotypes.

### Claim 8 (depends on 1)

A method of protecting a bovine from FMDV infection comprising administering to said bovine the immunogenic composition according to claim 1.

### Claim 9 (depends on 3)

The composition according to claim 3, wherein the CpG containing immunostimulatory oligonucleotide is present in the amount of about 50 to about 400 μg per dose and DEAE Dextran is present in the amount of about 10 to about 300 mg per dose.

### Claim 10 (depends on 9)

The composition according to claim 9 wherein the CpG containing immunostimulatory oligonucleotide is present in the amount of about 100 to about 250 μg per dose and DEAE Dextran is present in the amount of about 50 to about 200 mg per dose.

### Claim 11 (depends on 3)

The composition according to claim 3, wherein the oil is a mineral oil.

### Claim 12 (depends on 11)

The composition of claim 11, wherein the CpG containing immunostimulatory oligonucleotide is present in the amount of about 100 to about 250 μg per dose and DEAE Dextran is present in the amount of about 50 to about 200 mg per dose.

### Claim 13 (depends on 12)

The composition according to claim 12 wherein the CpG containing immunostimulatory oligonucleotide is present in the amount of about 100 μg per dose and DEAE Dextran is present in the amount of about 100 mg per dose.

### Claim 14 (depends on 12)

A method of protecting a bovine from FMDV infection comprising administering to said bovine the immunogenic composition according to claim 12.

### Claim 15 (depends on 13)

A method of protecting a bovine from FMDV infection comprising administering to said bovine the immunogenic composition according to claim 13.