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Patexia Research
Patent No. US 11224647
Issue Date Jan 18, 2022
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Patent 11224647 - Safe potent single platform vaccine against Tier 1 select agents and other pathogens > Claims

  • 1. An immunogenic composition comprising: a recombinant attenuated Francisella tularensis subspecies holarctica live vaccine Strain (LVS) having a deleted CapB gene (SEQ ID NO: 1) which comprises a F. tularensis promoter that expresses a fusion protein comprising an antigenic polypeptide epitope present in a Burkholderia pseudomallei polypeptide;wherein:the fusion protein expressed by the F. tularensis promoter is less than 80 kilodaltons in size; andthe antigenic polypeptide epitope elicits an immune response in a mammalian host when the immunogenic composition is administered orally, intradermally (i.d.), subcutaneously (s.q.), intramuscularly (i.m.), or intranasally (i.n.) to the mammalian host.
    • 2. The immunogenic composition of claim 1, wherein the antigenic polypeptide epitope is present in a Burkholderia pseudomallei polypeptide selected from:Hcp-1 (SEQ ID NO: 35),Hcp-2 (SEQ ID NO: 36),Hcp-3 (SEQ ID NO: 37),Hcp-4 (SEQ ID NO: 38),Hcp-6 (SEQ ID NO: 39),LolC (SEQ ID NO: 40),TypA (SEQ ID NO: 41),BipB (SEQ ID NO: 42),BipC (SEQ ID NO: 43),BipD (SEQ ID NO: 44),Omp3 (SEQ ID NO: 45),Omp7 (SEQ ID NO: 46),Omp85 (SEQ ID NO: 47),OmpW (SEQ ID NO: 48),PotF (SEQ ID NO: 49),OppA (SEQ ID NO: 50),BopA (SEQ ID NO: 51),BimA (SEQ ID NO: 52),BPSL1897 (SEQ ID NO: 53),BPSL3369 (SEQ ID NO: 54),BPSL2287 (SEQ ID NO: 55),BPSL2765 (SEQ ID NO: 56), andVgrG5 (SEQ ID NO: 57).
    • 3. The immunogenic composition of claim 1, wherein the F. tularensis promoter comprises a bfr promoter (SEQ ID NO: 13) and/or an omp promoter (SEQ ID NO: 14).
    • 4. The immunogenic composition of claim 1, wherein the LVS expresses two or more antigenic polypeptide epitopes present in a Burkholderia pseudomallei polypeptide.
    • 5. A method of generating an immune response in a mammal comprising administering the immunogenic composition of claim 1 to the mammal so that an immune response is generated to the antigenic polypeptide epitope present in a Burkholderia pseudomallei polypeptide.
      • 6. The method of claim 5, wherein the method comprises administering the immunogenic composition of claim 1 in a primary vaccination; and administering the immunogenic composition of claim 1 in a subsequent homologous booster vaccination.
        • 8. The method of claim 6, wherein the method comprises administering the immunogenic composition to the mammal less than 4 times.
      • 7. The method of claim 5, wherein the method consists essentially of administering the immunogenic composition of claim 1 in a primary vaccination; and administering the immunogenic composition of claim 1 in a subsequent homologous booster vaccination.
      • 9. The method of claim 5, wherein the method comprises administering the composition of claim 1 in a primary vaccination; and administering a second heterologous immunogenic composition comprising the antigenic polypeptide epitope present in a Burkholderia pseudomallei polypeptide in a subsequent booster vaccination.
        • 10. The method of claim 9, wherein the second immunogenic composition comprises an attenuated strain of Listeria monocytogenes expressing the antigenic polypeptide epitope.
          • 12. The method of claim 10, wherein the method comprises administering the composition of claim 1 and the second immunogenic composition to the mammal less than a total of four times.
            • 13. The method of claim 12 wherein method comprises administering a single dose of the composition of claim 1, and one or more doses of the second immunogenic composition.
    • 11. The method of claim 1, wherein the fusion protein is less than 50 kilodaltons.
  • 14. An immunogenic composition comprising: a recombinant attenuated Francisella tularensis subspecies holarctica live vaccine Strain (LVS) having a deleted CapB gene (SEQ ID NO: 1) which comprises a F. tularensis promoter that expresses a fusion protein comprising an antigenic polypeptide epitope present in a Burkholderia pseudomallei polypeptide;wherein:the F. tularensis promoter comprises a bfr promoter (SEQ ID NO: 13);the antigenic polypeptide epitope is present in a Burkholderia pseudomallei Hep-6 (SEQ ID NO: 39) polypeptide;the fusion protein is less than 80 kilodaltons in size; andthe antigenic polypeptide epitope elicits an immune response in a mammalian host when the immunogenic composition is administered orally, intradermally (i.d.), subcutaneously (s.q.), intramuscularly (i.m.), or intranasally (i.n.) to the mammalian host.
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