# US 10,500,270 B2 · Multivalent recombinant avian herpes viruses and vaccines for immunizing avian species

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- Number: US 10,500,270 B2
- Document ID: US10500270B2
- Status: Granted
- Kind: B2
- Application number: 15/972,283
- Filed: 2018-05-07
- Published: 2018-09-13
- Granted: 2019-12-10
- Earliest claimed: 2012-03-30
- Assignees: Ceva Sante Animale
- Applicants: Ceva Sante Animale
- Inventors: Ayumi Fujisawa; Mayumi Kubomura; Sakiko Saeki; Shuji Saito
- Web page: https://patentgrep.com/patent/US10500270B2

## CPC

- A61K 39/245: Herpetoviridae, e.g. herpes simplex virus
- A61K 39/12: Viral antigens
- A61K 39/17: Newcastle disease virus
- A61P 31/22: for herpes viruses
- A61P 37/04: Immunostimulants
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- C12N 15/86: Viral vectors
- A61K 2039/5256: {expressing foreign proteins}
- A61K 2039/552: {Veterinary vaccine}
- A61K 2039/70: {Multivalent vaccine}
- C12N 2710/16321: Viruses as such, e.g. new isolates, mutants or their genomic sequences
- C12N 2710/16334: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2710/16343: viral genome or elements thereof as genetic vector
- C12N 2720/10034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/18134: 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

The present invention relates to a recombinant avian herpes virus, which comprises at least two recombinant nucleotide sequences, each recombinant nucleotide sequence encoding a distinct antigenic peptide, wherein the at least two recombinant nucleotide sequences are inserted into distinct non-coding regions of the viral genome chosen among the region located between UL44 and UL45, the region located between UL45 and UL46, the region located between US10 and SORF3, and the region located between SORF3 and US2.

## Claims

### Claim 1

A recombinant herpes virus of turkeys (HVT), which comprises at least two recombinant nucleotide sequences, each recombinant nucleotide sequence encoding a distinct avian antigenic peptide, wherein one of said at least two recombinant nucleotide sequences is inserted into a non-coding region of the viral genome located between UL45 and UL46 under control of a Pec promoter, and another one of said at least two recombinant nucleotide sequences is inserted into a non-coding region of the viral genome located between UL44 and UL45, between US10 and SORF3, or between SORF3 and US2.

### Claim 2 (depends on 1)

The recombinant HVT of claim 1, wherein one recombinant nucleotide sequence is inserted into a non-coding region of the viral genome located between UL45 and UL46 under control of a Pee promoter, and one recombinant nucleotide sequence is inserted into a non-coding region of the viral genome located between SORF3 and US2.

### Claim 3 (depends on 2)

The recombinant HVT of claim 2, wherein the recombinant nucleotide sequence inserted into the non-coding region of the viral genome located between SORF3 and US2 is under control of a mCMV IE1 promoter.

### Claim 4 (depends on 1)

The recombinant HVT of claim 1, wherein the recombinant nucleotide sequence inserted into the non-coding region of the viral genome located between UL45 and UL46 under control of a Pec promoter encodes a F protein of Newcastle disease virus (NDV) or an immunogenic fragment thereof.

### Claim 5 (depends on 2)

The recombinant HVT of claim 2, wherein the recombinant nucleotide sequence inserted into the non-coding region of the viral genome located between SORF3 and US2 encodes a surface protein hemagglutinin (HA) of an avian influenza virus or an immunogenic fragment thereof.

### Claim 6 (depends on 1)

The recombinant HVT of claim 1, which comprises (i) a recombinant nucleotide sequence encoding a F protein of NDV, or an immunogenic fragment thereof, under control of the Pee promoter, inserted into a non-coding region of the viral genome located between UL45 and UL46, and (ii) a recombinant nucleotide sequence encoding a surface protein hemagglutinin (HA) of an avian influenza virus or an immunogenic fragment thereof, under control of the mCMV IE1 promoter, inserted into a non-coding region of the viral genome located between SORF3 and US2.

### Claim 7 (depends on 3)

The recombinant HVT according to claim 3, wherein the mCMV IE1 promoter comprises SEQ ID NO: 19.

### Claim 8 (depends on 1)

The recombinant HVT according to claim 1, wherein the Pec promoter comprises SEQ ID NO: 2.

### Claim 9 (depends on 1)

A multivalent vaccine which comprises an effective immunizing amount of a recombinant HVT of claim 1.

### Claim 10 (depends on 9)

A method for vaccinating an avian simultaneously against at least two pathogens, comprising administering to said avian a multivalent vaccine of claim 9.

### Claim 11 (depends on 9)

A vaccination kit for immunizing avian species which comprises the following components:
a) an effective amount of the vaccine of claim 9, and
b) a means for administering said components to said species.

### Claim 12 (depends on 1)

The recombinant HVT of claim 1, wherein one recombinant nucleotide sequence is inserted into a non-coding region of the viral genome located between UL45 and UL46 under control of a Pee promoter, and one recombinant nucleotide sequence is inserted into a non-coding region of the viral genome located between US10 and SORF3.
