IP Library Granted Patent US 12,385,068
Granted Patent B2
US 12,385,068 · App. 17/812,732 · Granted Aug 12, 2025

Recombinant HVT vectors expressing multiple antigens of avian pathogens and uses thereof

Inventors: Michel Bublot (Chaponost, FR); Teshome Mebatsion (Watkinsville, GA); Joyce Pritchard (Gainesville, GA); Perry Linz (Jefferson, GA); Aemro Kassa (Watkinsville, GA)
Assignee: BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
C12N15/869A61K39/12A61K39/155A61K39/245A61K39/295C07K14/03C07K14/08C12N7/00C12N2710/16311C12N2710/16334C12N2710/16343C12N2710/16363C12N2720/10034C12N2760/16163C12N2760/18134C12N2760/18163C12N2830/20C12N2830/50C12N2840/203
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Quick Facts
Patent No.
US 12,385,068
App. No.
17/812,732
Granted
Aug 12, 2025
Kind
B2
Abstract

The present invention provides recombinant herpesvirus of turkeys (HVT) vectors that contain and express antigens of avian pathogens, compositions comprising the recombinant HVT vectors and polyvalent vaccines comprising the recombinant HVT vectors. The present invention further provides methods of vaccination against a variety of avian pathogens and method of producing the recombinant HVT vectors.

Claims (27)

1. A vaccine comprising a recombinant herpesvirus of turkeys (HVT) vector, wherein the HVT vector comprises a first heterologous polynucleotide coding for and expressing an Infectious Bursal Disease Virus (IBDV) viral protein 2 (VP2) antigen and a second heterologous polynucleotide coding for and expressing a Newcastle Disease Virus Fusion Protein (NDV-F) antigen,

wherein the IBDV VP2 antigen has at least 85% sequence identity to a polypeptide having the sequence as set forth in SEQ ID NO:2, and wherein the NDV-F antigen has at least 85% sequence identity to a polypeptide having the sequence as set forth in SEQ ID NO:5;

wherein the two heterologous polynucleotides are inserted into one locus in a non-essential region of the HVT genome selected from the group consisting of intergenic region 1 locus, intergenic region 2 locus, intergenic region 3 locus, UL43 locus, US10 locus, US2 locus, and SORF3/US2 locus;

wherein the two heterologous polynucleotides are linked by internal ribosome entry site (IRES); and

wherein the expression of the two heterologous polynucleotides is driven by a mouse cytomegalovirus (mCMV) immediate early (IE) promoter or human cytomegalovirus (hCMV) IE promoter.

2. The vaccine of claim 1 , wherein the first heterologous polynucleotide is operably linked to mCMV IE promoter at the 5′ end, and the IRES at the 3′ end.

3. The vaccine of claim 1 , wherein the non-essential region is the IG1 locus of the HVT genome.

4. The vaccine of claim 1 , wherein the IBDV VP2 antigen has at least 90%, 95%, 96%, 97%, 98% or 99% sequence identity to a polypeptide having the sequence as set forth in SEQ ID NO:2.

5. The vaccine of claim 1 , wherein the IBDV VP2 antigen has the polypeptide sequence as set forth in SEQ ID NO: 2.

6. The vaccine of claim 1 , wherein the first heterologous polynucleotide encoding the IBDV VP2 antigen has at least 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98% or 99% sequence identity to a polynucleotide having the sequence as set forth in SEQ ID NO:1.

7. The vaccine of claim 1 , wherein the first heterologous polynucleotide encoding the IBDV VP2 antigen has the sequence as set forth in SEQ ID NO: 1.

8. The vaccines of claim 1 , wherein the NDV-F antigen has at least 90%, 95%, 96%, 97%, 98% or 99% sequence identity to a polypeptide having the sequence as set forth in SEQ ID NO:5.

9. The vaccines of claim 1 , wherein the NDV-F antigen has the polypeptide sequence as set forth in SEQ ID NO: 5.

10. The vaccine of claim 1 , wherein the second heterologous polynucleotide encoding the NDV-F antigen has at least 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98% or 99% sequence identity to a polynucleotide having the sequence as set forth in SEQ ID NO:3.

11. The vaccine of claim 1 , wherein the second heterologous polynucleotide encoding the NDV-F antigen has the sequence as set forth in SEQ ID NO: 3.

12. The vaccines of claim 1 , wherein the expression of the NDV-F antigen is regulated by the Simian virus 40 (SV40) poly A signal having the sequence as set forth in SEQ ID NO: 8.

13. The vaccine of claim 1 , wherein the IRES has the sequence as set forth in SEQ ID NO: 10.

14. The vaccine of claim 1 , wherein the first heterologous polynucleotide has the sequence as set forth in SEQ ID NO: 1, and wherein the second heterologous polynucleotide has the sequence as set forth in SEQ ID NO: 3;

wherein the non-essential region is the IG1 locus of the HVT genome;

wherein the first heterologous polynucleotide is operably linked to a mCMV IE promoter at the 5′ end, and the IRES at the 3′ end, and wherein the IRES has the sequence as set forth in SEQ ID NO: 10; and

wherein the expression of the NDV-F antigen is regulated by the SV40 poly A signal having the sequence as set forth in SEQ ID NO: 8.

15. The vaccine of claim 1 , further comprising a pharmaceutically or veterinarily acceptable carrier, excipient, vehicle or adjuvant.

16. A method of inducing an immunological response in an animal against one or more antigens or a protective response in an animal against one or more avian pathogens, comprising inoculating the animal at least once with the vaccine of claim 15 .

17. The method of claim 16 , wherein the animal is an avian.

18. The method of claim 16 , wherein the avian pathogen is selected from the group consisting of Newcastle Disease Virus (NDV) and Infectious Bursal Disease Virus (IBDV).

19. The method of claim 16 , wherein the vaccine is administered to one-day old chicks subcutaneously or intramuscularly.

20. The method of claim 16 , wherein the vaccine is administered to an avian in ovo in 17-19 day-old embryos.

Assignments (4)
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE FROM BOEHRINGER INGELHEIM VETMEDICA GMBH TO BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC. PREVIOUSLY RECORDED ON REEL 62025 FRAME 107. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT . Recorded Jul 10, 2025
From: BOEHRINGER INGELHEIM VETMEDICA GMBH
To: BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
Reel/Frame 071946/0816 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 8, 2022
From: BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
To: BOEHRINGER INGELHEIM VETMEDICA GMBH
Reel/Frame 062025/0107 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 15, 2022
From: BUBLOT, MICHEL; MEBATSION, TESHOME; PRITCHARD, JOYCE; LINZ, PERRY; KASSA, AEMRO
To: MERIAL, INC.
Reel/Frame 061106/0042 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 15, 2022
From: MERIAL, INC.
To: BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
Reel/Frame 061447/0534 →
Continuity (5)
Continuation 17035109 · Sep 28, 2020
Continuation 16393743 · Apr 24, 2019
Continuation 15840764 · Dec 13, 2017
Provisional Application 62433842 · Dec 14, 2016
Related Publication 20230175017A1 · Jun 8, 2023
References Cited (37)
US 6306400B1 · Bublot et al. · 2001 [cited by applicant]
US 20140147457A1 · Bublot et al. · 2014 [cited by applicant]
US 20160375122A1 · Mebatsion · 2016 [cited by examiner]
US 20170043006A1 · Reddy · 2017 [cited by examiner]
CN 103072306A · 2013 [cited by applicant]
CN 103074306A · 2013 [cited by applicant]
CN 106701693A · 2017 [cited by applicant]
JP H11503009A · 1999 [cited by applicant]
JP 2001513630A · 2001 [cited by applicant]
JP 2006055171A · 2006 [cited by applicant]
JP 2015500631A · 2015 [cited by applicant]
JP 2015500806A · 2015 [cited by applicant]
WO 1996005291A1 · 1996 [cited by applicant]
WO 1996029396A1 · 1996 [cited by applicant]
WO 1998037216A1 · 1998 [cited by applicant]
WO WO0105988A1 · 2001 [cited by examiner]
WO 2013057235A1 · 2013 [cited by applicant]
WO 2013057236A1 · 2013 [cited by applicant]
WO 2013082317A2 · 2013 [cited by applicant]
WO 2013082327A1 · 2013 [cited by applicant]
WO 2018112051A1 · 2018 [cited by applicant]
Hall RN, Meers J, Fowler EV, Mahony TJ. Identification of non-essential loci within the Meleagrid herpesvirus 1 genome. Virol J. Aug. 27, 2015;12:130. (Year: 2015). [cited by examiner]
Zai X, Shi B, Shao H, Qian K, Ye J, Yao Y, Nair V, Qin A. Identification of a Novel Insertion Site HVT-005/006 for the Generation of Recombinant Turkey Herpesvirus Vector. Front Microbiol. May 25, 2022; 13:886873. (Year… [cited by examiner]
Zhang F, Chen W, Ma C, Zhang Z, Zhao P, Du Y, Zhang Y, Duan L, Fang J, et al. Transcriptional activity comparison of different sites in recombinant Marek's disease virus for the expression of the H9N2 avian influenza vi… [cited by examiner]
López de Juan Abad BA, Cortes AL, Correa M, Gimeno IM. Evaluation of Factors That Influence Dose Variability of Marek's Disease Vaccines. Avian Dis. Dec. 2019;63(4):591-598. (Year: 2019). [cited by examiner]
Atasoy, MO, 2021. Herpesvirus of Turkeys as a vaccine vector in viral diseases: Pros and cons. Hosts and Viruses, 8(3): 13-20. (Year: 2021). [cited by examiner]
Linda Gergen et al., “A double recombinant 1-20 herpesvirus of turkeys for the protection of chicken against Newcastle, infectious laryngotracheitis and Marke's diseases”, Avian Pathology, vol. 48, No. 1, Jan. 1, 2019, … [cited by applicant]
Gimeno Isabel M., Cortes Aneg L., Guy James S., et al. “Replication of recombinant herpesvirus of turkey expressing genes of infectious laryngotracheitis virus in specific pathogen free and broiler chickens following&he… [cited by applicant]
Johnson (2010); Avian Dis. 54(4):1251-1258. [cited by applicant]
Zhao (2014); J. Virol. 88(15):8397-8406. [cited by applicant]
Jin Hee Kim, et al., “High Cleavage Efficiency of a 2A Peptide Derived from Porcine Teschovirus-1 in Human Cell Lines, Zebrafish and Mice”, PLos One, 2011, vol. 6, Part 4, e18556. [cited by applicant]
Kingham et al., The genome of herpesvirus of turkeys: comparative analysis with Marek's disease viruses, Journal of General Virology, 2001, 82(5):1123-1135. [cited by applicant]
First page of GenBank acc. Nr. NC_002641: genome of HVT strain FC-126 (first seen 2001). [cited by applicant]
First page of GenBank accession No. NC_003985: genome of porcine Teschovirus-1 (first seen 2002). [cited by applicant]
Ngoi et al., Current Gene Therapy, vol. 4, 2004, pp. 15-31. [cited by applicant]
Liu et al., Viruses, vol. 2, 2016, p. 301. [cited by applicant]
English Abstract of CN103074306A. [cited by applicant]