Immunostimulating compositions and uses therefore
Inventors
TABOR, Alicja • Bellgard, Matthew • RODRIGUEZ VALLE, Manuel • Guerrero, Felicito
Assignees
US Department of Agriculture USDA
Publication Number
US-11623945-B2
Publication Date
2023-04-11
Expiration Date
2038-02-06
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Abstract
The present invention relates to immunogenic polypeptides, immunogenic fragments thereof and compositions comprising same, for use in eliciting an immune response in a subject to a tick. The invention also provides for methods of using said compositions and polypeptides.
Core Innovation
The invention provides immunostimulatory compositions comprising one or more polypeptides that correspond to at least a portion of tick polypeptides, particularly from the Rhipicephalus microplus species complex. These compositions elicit significant cellular and/or humoral immune responses in a subject to a tick, thus offering therapeutic and prophylactic utility for combating tick infestations.
The compositions include recombinant or synthetic polypeptides corresponding to tick polypeptides selected from TC12130, MPAAN50tr, MPAA730tr, TC12142, TC10097, TC9753, TC13011, TC8992, and TC5995, as well as immunogenic fragments and variants thereof, optionally conjugated to carrier proteins and combined with adjuvants such as Freund's adjuvant, saponin adjuvants, or mineral oil adjuvants. The compositions may include multiple polypeptides simultaneously and also nucleic acid constructs encoding these polypeptides, enabling diverse modes of administration and enhanced immunogenicity.
The problem being solved is the substantial economic and animal welfare impact caused by tick infestations in livestock, particularly cattle, including transmission of tick-borne diseases such as babesiosis and anaplasmosis. Existing chemical acaricide treatments are undermined by widespread tick resistance and concerns about chemical residues. Prior vaccines like TICKGARD PLUS, based on the antigen Bm86, showed limited geographical efficacy and required frequent booster shots, leading to poor adoption. There is thus an unmet need for new treatments and compositions that effectively prevent or reduce tick infestations and are broadly efficacious.
Claims Coverage
The patent includes one independent claim covering a composition with a recombinant or synthetic polypeptide and an adjuvant for immune potentiation. The inventive features relate to specific polypeptide sequences and their inclusion in immunostimulatory compositions.
Composition comprising specific tick polypeptide epitopes and adjuvant
A composition comprising a recombinant or synthetic polypeptide including or consisting of the amino acid sequences corresponding to residues 140-154 (SEQ ID NO: 52) and/or 159-179 (SEQ ID NO: 51) of SEQ ID NO: 7 (TC12142), together with an adjuvant for potentiating immune response to the polypeptide.
Composition including additional polypeptides from tick antigens TC9753, TC8992, and TC5995
The composition may further comprise polypeptides including or consisting of amino acid residues 20-37, 96-106, 164-173, and 185-200 of SEQ ID NO: 10 (TC9753); residues 198-209 of SEQ ID NO: 14 (TC8992); and residues 91-132, 104-124, and 117-132 of SEQ ID NO: 16 (TC5995).
Inclusion of carrier protein and pharmaceutically acceptable excipients
The composition optionally includes a carrier protein conjugated to the recombinant or synthetic polypeptide and/or a pharmaceutically acceptable carrier, excipient, or diluent.
Recombinant or synthetic polypeptide comprising full-length TC12142 sequence
The polypeptide can comprise or consist of the amino acid sequence of full-length SEQ ID NO: 7 (TC12142).
Compositions containing polypeptides corresponding to one or more of SEQ ID NOs: 7, 10, 14, and 16
Compositions may combine polypeptides consisting of the full-length sequences of TC12142 (SEQ ID NO: 7) with polypeptides comprising or consisting of TC9753 (SEQ ID NO: 10), TC8992 (SEQ ID NO: 14), and TC5995 (SEQ ID NO: 16), in various combinations as described in the claims.
The claims cover immunostimulatory compositions comprising defined polypeptide antigens derived from tick proteins TC12142 and optionally TC9753, TC8992, and TC5995 combined with adjuvants and optionally carrier proteins and pharmaceutically acceptable components. The coverage is centered on specific epitope-containing sequences and their use in eliciting immune responses to ticks.
Stated Advantages
The compositions elicit significant cellular and/or humoral immune responses against tick antigens.
They offer therapeutic and prophylactic applications in the treatment and prevention of tick infestations.
They reduce reliance on chemical acaricides, helping to decrease chemical residues in cattle and the environment.
They overcome limitations of previous vaccines like TICKGARD PLUS, including improved efficacy and reduced booster frequency.
Documented Applications
Use in eliciting an immune response in livestock (e.g., cattle, buffalo, sheep, goats, horses) to prevent or treat tick infestations.
Prophylactic and therapeutic vaccination of mammals to reduce tick numbers and associated diseases such as babesiosis and anaplasmosis.
Methods for reducing transmission risk of ticks in animal populations.
Production of antigen-binding molecules, including antibodies, specific to tick polypeptides for diagnostic or therapeutic uses.
Application in prime-boost immunization regimens for durable protection.
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