Recombinant modified vaccinia virus Ankara (MVA) foot and mouth disease virus (FMDV) vaccine
Inventors
Steigerwald, Robin • Kalla, Markus
Assignees
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Publication Number
US-11103570-B2
Publication Date
2021-08-31
Expiration Date
Abstract
The present invention relates to modified poxviral vectors and to methods of making and using the same. In particular, the invention relates to recombinant modified vaccinia virus Ankara-based (MVA-based) vaccine against FMDV infection and to related products, methods and uses. Specifically, the present invention relates to genetically engineered (recombinant) MVA vectors comprising at least one heterologous nucleotide sequence encoding an antigenic determinant of a FMDV protein. The invention also relates to products, methods and uses thereof, e.g., suitable to induce a protective immune response in a subject.
Core Innovation
The invention relates to a recombinant Modified Vaccinia virus Ankara (MVA) engineered to elicit a protective immune response to foot-and-mouth disease virus (FMDV) when administered to animals, particularly cattle. The recombinant MVA comprises a first transcriptional unit inserted into intergenic region IGR 88/89 that encodes an FMDV P1 region operably linked to promoter Pr13.5-long, and a second transcriptional unit inserted into intergenic region IGR 64/65 that encodes the FMDV 3C protease downstream from an HIV frameshift and operably linked to weak promoter PrMVA095R, wherein the 3C protease comprises mutation C142T.
The invention addresses the need for a vaccine that elicits protection against FMDV and prevents the development of FMDV-caused lesions in the animal. The recombinant MVA is described as MVA-BN-based, including specific derivatives, with defined insertion-site choices and transcriptional unit and promoter options tied to the inserted heterologous FMDV antigenic determinants.
In use, the vaccine comprises the recombinant MVA together with a pharmaceutical or veterinary acceptable carrier, excipient, or vehicle, and is administered to elicit protective humoral and cellular immunity. The document includes cattle evidence showing full protection from an A24 Cruzeiro challenge, with disease scoring between vaccinated and unvaccinated cattle, and examples include construction and verification of recombinant MVA-BN-FMDV constructs and analyses related to expression and processing for antigenic determinant presentation, including virus-like particles (VLPs).
Claims Coverage
The document includes two independent claims. Both independent claims focus on the same two transcriptional units inserted into specific MVA intergenic regions with specified promoter and frameshift context and the C142T mutation, and they require a protective immune response that prevents FMDV-caused lesions.
Recombinant MVA with two transcriptional units inserted into IGR 88/89 and IGR 64/65
A vaccine that comprises a recombinant MVA having a first transcriptional unit inserted into intergenic region IGR 88/89 comprising a nucleotide sequence encoding the FMDV P1 region operably linked to Pr13.5-long, and a second transcriptional unit inserted into intergenic region IGR 64/65 comprising a nucleotide sequence encoding the FMDV 3C protease downstream from an HIV frameshift and operably linked to a weak promoter PrMVA095R, wherein the 3C protease comprises the mutation C142T.
Protective immune response preventing FMDV-caused lesions in cattle
A vaccine wherein administration to cattle elicits a protective immune response to FMDV that prevents the development of FMDV-caused lesions in said cattle.
Method of administering the recombinant MVA vaccine to induce protection in an animal
A method of inducing a protective immune response against FMDV in an animal comprising administering an effective amount of a recombinant MVA comprising a first transcriptional unit inserted into IGR 88/89 with the FMDV P1 region operably linked to Pr13.5-long, and a second transcriptional unit inserted into IGR 64/65 with the FMDV 3C protease downstream from an HIV frameshift and operably linked to the weak promoter PrMVA095R, wherein the 3C protease comprises the mutation C142T.
Protective immune response preventing FMDV-caused lesions in the animal
A method wherein the protective immune response prevents the development of FMDV-caused lesions in the animal.
Overall, the claims are anchored on a recombinant MVA-BN-based construct with specified insertion regions that co-expresses the FMDV P1 region and an HIV frameshift-associated FMDV 3C protease under Pr13.5-long and PrMVA095R promoter control, including the C142T mutation, combined with administration to induce a protective immune response that prevents FMDV-caused lesions.
Stated Advantages
Prevents the development of FMDV-caused lesions in cattle.
Provides a protective immune response to FMDV when administered to cattle.
Prevents the development of FMDV-caused lesions in an animal after administration of the recombinant MVA vaccine.
Documented Applications
Vaccination of cattle to elicit a protective immune response to FMDV and prevent FMDV-caused lesions, including prevention of tongue lesions, upon challenge with A24 Cruzeiro.
Inducing a protective immune response against FMDV in an animal by administering an effective amount of the recombinant MVA vaccine, thereby preventing FMDV-caused lesions.
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