# US 9,623,106 B2 · Bluetongue virus vaccine and immunogenic compositions, methods of use and methods of producing same

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- Number: US 9,623,106 B2
- Document ID: US9623106B2
- Status: Granted
- Kind: B2
- Application number: 14/938,030
- Filed: 2015-11-11
- Published: 2016-03-03
- Granted: 2017-04-18
- Earliest claimed: 2007-11-21
- Assignees: Zoetis Services LLC
- Applicants: Zoetis Services LLC
- Inventors: Joan Plana Duran
- Web page: https://patentgrep.com/patent/US9623106B2

## CPC

- A61K 39/15: Reoviridae, e.g. calf diarrhea virus
- A61K 39/12: Viral antigens
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/12: Antivirals
- A61P 31/14: for RNA viruses
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- A61K 2039/5252: {inactivated (killed)}
- A61K 2039/552: {Veterinary vaccine}
- A61K 2039/55505: {Inorganic adjuvants}
- A61K 2039/55577: {Saponins; Quil A; QS21; ISCOMS}
- C12N 2720/12134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2720/12163: by chemical treatment
- 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

Provided are immunogenic and vaccine compositions and methods for their preparation and use, which compositions are effective in protecting against, minimizing the severity of, preventing, and/or ameliorating infection of ruminants with Bluetongue virus. Administration to an animal of at least one dose of an adjuvanted and twice inactivated Bluetongue virus composition as disclosed herein is effective in providing immunity to the animal and protection from infection with Bluetongue virus, thereby reducing the severity of and/or preventing disease caused by one or more strains or serotypes of Bluetongue virus.

## Claims

### Claim 1

A method of producing inactivated whole Bluetongue virus (BTV) that protects animals from viremia, the method comprising the step of first treating the BTV with binary ethyleneimine (BEI) while the BTV remains in a complete culture, and then retreating the BTV with binary ethyleneimine, wherein the resulting BTV is inactivated and remains immunogenic.

### Claim 2 (depends on 1)

The method of claim 1, wherein the BTV is serotype 4, and the concentration of BEI used in the first step is 10 mM.

### Claim 3 (depends on 2)

The method of claim 2, wherein the concentration of BEI used in the second step is 5 mM.

### Claim 4

A vaccine composition for protecting an animal against BTV, comprising an immunogenically effective amount of at least one strain of twice inactivated BTV, and a biologically acceptable carrier, wherein the composition contains cell debris from the complete culture in which said BTV was first contacted with an inactivating agent.

### Claim 5 (depends on 4)

The vaccine composition of claim 4, further comprising an adjuvant selected from the group consisting of one or more of aluminum hydroxide, saponin, SL-CD, Carbopol and SP-Oil.