Mycoplasma bovis vaccine product
Inventors
Briggs, Robert E • Tatum, Fred M
Assignees
US Department of Agriculture USDA
Publication Number
US-11679150-B2
Publication Date
2023-06-20
Expiration Date
2041-03-02
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Abstract
The present invention relates to modified Mannheimia haemolytica (M. haemolytica) lktCA gene cluster cassettes, compositions comprising such cassettes, methods of using such cassettes and compositions, and kits comprising such cassettes and compositions. Also described herein are Mycoplasma bovis (M. bovis) protective antigens, compositions comprising such antigens, methods of using such antigens and compositions, and kits comprising such antigens and compositions. Also described herein are modified M. haemolytica lktCA gene cluster cassettes engineered to express M. bovis protective antigens, compositions comprising such cassettes, methods of using such cassettes and compositions, and kits comprising such cassettes and compositions.
Core Innovation
The present invention provides modified Mannheimia haemolytica (M. haemolytica) lktCA gene cluster cassettes comprising an insertion of a polynucleotide encoding an additional M. haemolytica leukotoxin neutralizing epitope, resulting in a modified cassette that encodes two leukotoxin neutralizing epitopes. These modified cassettes are useful for the expression of bacterial or viral antigens and may further include polynucleotides encoding heterologous antigens, including Mycoplasma bovis (M. bovis) protective antigens such as EF-Tu and DnaK or chimeric M. bovis antigens.
The invention includes compositions, vectors, and bacterial strains comprising such modified M. haemolytica lktCA gene cluster cassettes, kits containing these elements, and methods of vaccination employing these cassettes or compositions to provoke an immune response in animals against M. haemolytica and/or M. bovis.
The problem addressed by the invention stems from the difficulty of treating and controlling M. bovis infections in cattle and related species owing to its varied disease manifestations, difficult diagnosis, and unreliable efficacy of existing vaccines. While M. haemolytica modified strains have been employed for vaccination against M. haemolytica-associated disease, there remains a need for vaccines that effectively protect against M. bovis, preferably using bacterial vectors capable of expressing M. bovis antigens.
Claims Coverage
The patent contains five claims including one independent claim. The claims disclose inventive features related to an M. bovis antigen, compositions containing the antigen, and methods of provoking immune responses in animals.
An M. bovis antigen comprising EF-Tu and a heat shock protein DnaK chimera
The invention covers an M. bovis antigen comprising a fusion or chimera of elongation factor thermos-unstable protein (EF-Tu) and heat shock protein DnaK.
Composition comprising the M. bovis antigen
Compositions disclosed include polypeptides of the M. bovis antigen, vaccines, or immunogenic compositions that include the EF-Tu/DnaK chimera.
Method for provoking an immune response in an animal
Methods involve administering at least one effective dose of a composition containing the M. bovis antigen to an animal to provoke an immune response.
Composition further comprising pharmaceutically acceptable carrier or adjuvant
The composition including the M. bovis antigen can optionally contain pharmaceutically acceptable carriers or adjuvants to facilitate vaccine formulation or immunogenicity enhancement.
Species coverage for immune response method
The method of provoking an immune response is applicable to animals including cattle, sheep, goats, pigs, bison, elk, camels, dogs, or deer.
The claims cover the EF-Tu/DnaK chimeric M. bovis antigen itself, compositions including it as a vaccine or immunogenic preparation, and methods of administering such compositions to a range of mammal species to provoke immune responses, optionally using carriers or adjuvants.
Stated Advantages
The vaccines using the modified M. haemolytica lktCA gene cluster cassettes elicit protective immune responses against both M. haemolytica and M. bovis infections in animals.
Use of these bacterial vector-based vaccines enables mucosal colonization and immune stimulation at sites where infection initiates, increasing efficacy.
The vaccine expressing an M. bovis antigen effectively reduces M. bovis lung load, middle ear infection, and systemic infection in vaccinated animals.
Vaccination reduces clinical symptoms such as fever duration and severity following BHV-1 and M. bovis challenge.
Inclusion of the M. bovis antigen payload in the vaccine enhances antibody responses to the M. bovis antigen and improves protection.
The bacterial vector vaccines are attenuated, safe, and maintain the ability to colonize mucosa without causing disease, increasing safety and vaccine effectiveness.
Documented Applications
Vaccination of cattle, including dairy and beef breeds, to protect against M. bovis-associated diseases such as pneumonia, otitis media, polyarthritis, and mastitis.
Vaccination of other mammals such as sheep, goats, pigs, bison, elk, camels, dogs, and deer against M. bovis infection.
Use as intranasal, injectable, or oral vaccines combining protection against M. haemolytica and M. bovis for multi-pathogen control.
Use as a platform for expressing heterologous antigens in bacterial vectors to create vaccines against multiple pathogens.
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