| Sonstiges: |
- Nachgewiesen in: USPTO Patent Grants
- Sprachen: English
- Patent Number: 9,345,759
- Publication Date: May 24, 2016
- Appl. No: 13/046317
- Application Filed: March 11, 2011
- Assignees: MERIAL, INC. (Duluth, GA, US)
- Claim: 1. A composition comprising a BTV (Bluetongue Virus) VP2 antigen and a pharmaceutically or veterinarily acceptable carrier, excipient, adjuvant, or vehicles; wherein a nucleic acid sequence encoding the BTV VP2 antigen is expressed in a duckweed plant and said encoded antigen is localized to the cytoplasm of the duckweed plant; wherein said encoded antigen is non-glycosylated, and partially purified; wherein SEQ ID NO: 26 is fused immediately upstream of the nucleic acid sequence encoding the BTV VP2 antigen; and wherein the BTV VP2 antigen has at least 95% sequence identity to the sequence as set forth in SEQ ID NO: 4, and provides a protective immunogenic response in an animal against BTV infection.
- Claim: 2. The composition of claim 1 , wherein the composition further comprises a BTV VP5 antigen having at least 95% identity to the sequence as set forth in SEQ ID NO: 10.
- Claim: 3. The composition of claim 1 , wherein the BTV antigen is substantially purified.
- Claim: 4. The composition of claim 1 , wherein the pharmaceutically or veterinarily acceptable carrier, adjuvant, excipient, or vehicle is a crystalline salt or an oil-in-water emulsion.
- Claim: 5. A method of vaccinating a host susceptible to BTV comprising at least one administration of the composition according to claim 1 .
- Claim: 6. The method of claim 5 comprising a prime-boost administration protocol.
- Claim: 7. The method of claim 6 , wherein said prime-boost administration comprises a prime-administration of the composition of claim 1 , and a boost-administration of a vaccine or composition comprising a recombinant viral vector that contains and expresses the BTV antigen in vivo, or an inactivated viral vaccine comprising the BTV antigen, or a DNA plasmid vaccine or composition that contains or expresses the BTV antigen.
- Claim: 8. The method of claim 6 , wherein the prime-boost administration comprises a prime-administration of a vaccine or composition comprising a recombinant viral vector that contains and expresses the BTV antigen in vivo, or an inactivated viral vaccine comprising the BTV, or a DNA plasmid vaccine or composition that contains or expresses the BTV antigen, and a boost-administration of the composition of claim 1 .
- Claim: 9. The method of claim 6 , wherein the prime-boost administration comprises a prime-administration of the composition of claim 1 , and a boost-administration of the composition of claim 1 .
- Claim: 10. The method of claim 5 , wherein the host is ovine, bovine, or caprine.
- Claim: 11. A plasmid comprising a DNA fragment, wherein said fragment comprises SEQ ID NO: 26 fused immediately upstream of the sequence as set forth in SEQ ID NO: 3, wherein the plasmid is for duckweed plant transformation, wherein the expression of the DNA fragment in the duckweed plant produces a BTV VP2 antigen which provides a protective immunogenic response in an animal against BTV infection, and wherein said antigen is cytoplasmically localized and non-glycosylated.
- Claim: 12. A stably transformed duckweed plant or culture transformed with a nucleic acid sequence encoding a BTV antigen, wherein SEQ ID NO: 26 is fused immediately upstream of the nucleic acid sequence encoding the BTV antigen, wherein the BTV antigen is BTV VP2 having at least 95% sequence identity to the sequence as set forth in SEQ ID NO: 4, wherein the BTV VP2 antigen is expressed and localized to the cytoplasm of the duckweed plant or culture and non-glycosylated; and wherein said antigen provides a protective immunogenic response in an animal against BTV infection.
- Claim: 13. The duckweed plant or culture of claim 12 comprising the plasmid of claim 11 .
- Claim: 14. The composition of claim 2 , wherein the BTV VP2 has the sequence as set forth in SEQ ID NO:4, and the BTV VP5 has the sequence as set forth in SEQ ID NO:10.
- Claim: 15. The plasmid of claim 11 , wherein the plasmid comprises an RbcS leader sequence.
- Claim: 16. The plasmid of claim 11 , wherein the plasmid comprises an ADH1 intron.
- Patent References Cited: 5690938 November 1997 Ermak et al. ; 5833995 November 1998 Roy et al. ; 2007/0280960 December 2007 Audonnet et al.
- Other References: Athmaram et al (Vaccine, 24, p. 2994-3000, 2006). cited by examiner ; Sallieau et al (see GenBank accession ACJ65032.1). cited by examiner ; Rybicki (Drug Discovery Today, 14(1/2), p. 16-24, Jan. 2009). cited by examiner ; Walker et al (Plant Cell Rep, 24, p. 629-641, 2005). cited by examiner ; Stoger et al (Current Opinion in Biotechnology, 16(2), pp. 167-173, 2005). cited by examiner ; Lobato (Veterinary Immunology and Immunopathology, 59, pp. 293-309, 1997). cited by examiner ; Athmaram, TN, et al., (2006) “Integration and expression of bluetongue VP2 gene in somatic embryos of peanut through particle bombardment method”, Vaccine 24: 2994-3000. cited by applicant ; Spreull, J. (1905). “Malarial catarrhal fever (bluetongue) of sheep in South Africa.” J. Comp. Path.. Ther. 18: 321-337. cited by applicant ; Wilson, WC., et al., (2000). “Molecular Evolution of Orbiviruses.” Proc USAHA 104: 169-180. cited by applicant ; Bonneau, KR., et al. (2001). “Occurrence of genetic drift and founder effect during quasispecies evolution of the VP2 and NS3/NS3A genes of bluetongue virus upon passage between sheep, cattle, and Culicoides sonorensis.” J Virol 75(17): 8298-305. cited by applicant ; Anderson, G. A., J. L. Stott, et al. (1985). “Subclinical and clinical bluetongue disease in cattle: clinical, pathological and pathogenic considerations.” Prog Clin Biol Res 178: 103-7. cited by applicant ; MacLachlan, NJ. (1994). “The pathogenesis and immunology of bluetongue virus infection of ruminants.” Comp Immunol Microbiol Infect Dis 17(3-4): 197-206. cited by applicant ; White, DM., et al. (2005). “Studies on overwintering of bluetongue viruses in insects.” J Gen Virol 86(Pt 2): 453-62. cited by applicant ; Roy, P. (1996). “Orbivirus structure and assembly.” Virology 216(1): 1-11. cited by applicant ; Verwoerd, DW., et al. (1972). “Structure of the bluetongue virus capsid.” J Virol 10(4): 783-94. cited by applicant ; Hassan, SS., et al., (1999). “Expression and functional characterization of bluetongue virus VP2 protein: role in cell entry.” J Virol 73(12): 9832-42. cited by applicant ; Huismans, H. et al., (1981). “Identification of the serotype-specific and group-specific antigens of bluetongue virus.” Onderstepoort J Vet Res 48(2): 51-8. cited by applicant ; De Mattos, CA., et al. (1994). “Heterogeneity of the L2 gene of field isolates of bluetongue virus serotype 17 from the San Joaquin Valley of California.” Virus Res 31(1): 67-87. cited by applicant ; Demaula, CD., et al. (2000). “Changes in the outer capsid proteins of bluetongue virus serotype ten that abrogate neutralization by monoclonal antibodies.” Virus Res 67(1): 59-66. cited by applicant ; Roy, P., et al. (1990). “Recombinant virus vaccine for bluetongue disease in sheep.” J Virol 64(5): 1998-2003. cited by applicant ; Huismans, H., et al. (1987). “Isolation of a capsid protein of bluetongue virus that induces a protective immune response in sheep.” Virology 157(1): 172-9. cited by applicant ; Andrew, M., et al. (1995). “Antigen specificity of the ovine cytotoxic T lymphocyte response to bluetongue virus.” Vet Immunol Immunopathol 47(3-4): 311-22. cited by applicant ; Lobato, ZI.,et al. (1997). “Antibody responses and protective immunity to recombinant vaccinia virus-expressed bluetongue virus antigens.” Vet Immunol Immunopathol 59(3-4): 293-309. cited by applicant ; Chargelegue et al., “Transgenic Plants for Vaccine Production: Expectations and Limitations”, Trends in Plant Science 2001, 6, 495-496. cited by applicant ; Schillberg et al., “Opportunities for Recombinant Antigen and Antibody Expression in Transgenic Plants—Technology Assessment”, Vaccine 2005, 23, 1764-1769. cited by applicant ; Arntzen et al., “Plant-derived Vaccines and Antibodies; Potential and Limitations”, Vaccine 2005, 23, 1753-1756. cited by applicant ; Koprowski, “Vaccines and Sera Through Plant biotechnology”, Vaccine 2005, 23, 1757-1763. cited by applicant ; MacLachlan, NJ., et al., (2004). “Bluetongue: Prodeedings of the Third International Symposium.”, Vet Italiana. 40: 1-730. cited by applicant
- Assistant Examiner: Uyeno, Stephen
- Primary Examiner: Fox, David T
- Attorney, Agent or Firm: Jarecki-Black, Judy ; Chen, Ruoyang ; Merial, Inc.
|
