VACCINE COMPOSITIONS AND METHODS FOR CONTROLLING FOOT-AND-MOUTH DISEASE

RU2025128699A3Pending Publication Date: 2026-07-10ИНДИАН КАУНСИЛ ОФ АГРИКАЛЧЕРАЛ РИСЁЧ +1

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Patent Information

Authority / Receiving Office: RU · RU
Patent Type: Applications
Current Assignee / Owner: ИНДИАН КАУНСИЛ ОФ АГРИКАЛЧЕРАЛ РИСЁЧ
Filing Date: 2024-03-14
Publication Date: 2026-07-10

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Claims

1. A vaccine comprising a foot-and-mouth disease antigen and an adjuvant comprising oil, a polycationic carrier and an immunostimulatory oligonucleotide, wherein said vaccine is a water-in-oil (W / O) emulsion, for use in preventing lower leg lesions caused by foot-and-mouth disease infection in ruminants, wherein said vaccine is administered as a single primary dose and one or more booster doses, wherein the first of said one or more booster doses is administered 7 to about 12 months after the single primary dose.

2. The vaccine of claim 1, wherein each subsequent booster dose is administered 7 to about 12 months after the previous booster dose.

3. The vaccine of claim 1 or 2, wherein the first booster dose is administered about 8, or about 9, or about 10, or about 11, or about 12 months after the single primary dose.

4. The vaccine according to any one of claims 1-3, wherein the cationic carrier is diethylaminoethyl dextran (DEAE-dextran).

5. The vaccine according to claim 4, wherein DEAE-dextran is present in an amount of 25-250 mg per dose.

6. The vaccine according to claim 5, wherein the immunostimulating oligonucleotide is present in an amount of 25-250 mcg per dose.

7. The vaccine according to claim 6, wherein the immunostimulating oligonucleotide is present in an amount of 50-150 mcg per dose.

8. The vaccine of any one of claims 1-7, wherein the vaccine contains at least 40% (v / v) oil.

9. The vaccine of claim 8, wherein the vaccine contains at least 45% (v / v) oil.

10. The vaccine of claim 9, wherein the vaccine comprises at least 48% (v / v) oil.

11. The vaccine of claim 10, wherein the vaccine comprises at least 52% (v / v) oil.

12. The vaccine of claim 11, wherein the vaccine contains at least 60% (v / v) oil.

13. The vaccine of any one of claims 1-12, wherein the oil is light mineral oil.

14. The vaccine according to any one of claims 1-13, wherein the antigen is obtained from foot-and-mouth disease virus serotypes O, A and / or Asia 1.

15. The vaccine according to any one of claims 1-13, wherein the antigen is obtained from foot-and-mouth disease virus serotypes O, A and / or C.

16. The vaccine according to any one of claims 1-13, wherein the antigen is obtained from foot-and-mouth disease virus serotypes SAT1, SAT2 and / or SAT3.

17. The vaccine according to any one of claims. 1-13, wherein the antigen is selected from a group consisting of O1 Manisa, O1 BFS or Campos, Asia 1 Shamir, A Iran '96, A22 Iraq, SAT2 Saudi Arabia, A10-61, A5, A12, A24 / Cruzeiro, C3 / Indaial, O1, C1-Pau, C1-C Santa A22 / 550 / Azerbaijan / 65, SAT1-SAT3, A, A / TNC / 71 / 94, A / IND / 2 / 68, A / IND / 3 / 77, A / IND / 5 / 68, A / IND / 7 / 82, A / IND / 16 / 82, A / IND / 17 / 7 / 8 / 8, A / IND / 7 / 17, A / IND / 19 / 76, A / IND / 20 / 82, A / IND / 22 / 82, A / IND / 25 / 81, A / IND / 26 / 82, A / IND / 54 / 79, A / IND / 57 / 79, A / IND / 73 / 79, A / IND / 85 / 79, A / IND / 8 / 6,7 A / APA / 25 / 84, A / APN / 41 / 84, A / APS / 44 / 05, A / APS / 50 / 05, A / APS / 55 / 05, A / APS / 66 / 05, A / APS / 68 / 05, A / BIM / 46 / 95, A / GUM / 33 / 84 / ORS / 84,6 A / ORS / 75 / 88, A / TNAn / 60 / 947 / Asia / 1, A / IRN / 05, Asia / IRN / 05, O / HK / 2001, 0 / UKG / 3952 / 2001, O / UKG / 4141 / 2001, Asia 1 / HNK / CHA / XK / 75, HK / XJ, O / UKG / 7039 / 2001, O / UKG / 9161 / 2001, O / UKG / 7299 / 2001, O / UKG / 4014 / 2001, O / UKG / 4998 / 2001, O / UKG / 9443 / 2001, O / UKG / 9443 / 2001, O / UKG / 7017 / 2001 O / UKG / 5681 / 2001, O / ES / 2001, HKN / 2002, O5India, O / BKF / 2 / 92, K / 37 / 84 / A, KEN / 1 / 76 / A, GAM / 51 / 98 / A, A10 / Holland,O / KEN / 1 / 91, O / IND49 / 97, O / IND65 / 98, O / IND64 / 98, O / IND48 / 98, O / IND47 / 98, O / IND82 / 97, O / IND81 / 99, O / IND81 / 98, O / IND79 / 97, O / IND78 / 97, O / IND75 / 97, O / IND74 / 97, O / IND70 / 97, O / IND66 / 98, O / IND63 / 97, O / IND61 / 97, O / IND57 / 98, O / IND56 / 98, O / IND55 / 98, O / IND54 / 98, O / IND469 / 98, O / IND465 / 97, O / IND464 / 97, O / IND424 / 97, O / IND423 / 97, O / IND420 / 97, O / IND414 / 97, O / IND411 / 97, O / IND410 / 97, O / IND409 / 97, O / IND407 / 97, O / IND399 / 97, O / IND39 / 97, O / IND391 / 97, O / IND38 / 97, O / IND384 / 97, O / IND380 / 97, O / IND37 / 97, O / IND352 / 97, O / IND33 / 97, O / IND31 / 97, O / IND296 / 97, O / IND23 / 99, O / IND463 / 97, O / IND461 / 97, O / IND427 / 98, O / IND28 / 97, O / IND287 / 99, O / IND285 / 99, O / IND282 / 99, O / IND281 / 97, O / IND27 / 97, O / IND278 / 97, O / IND256 / 99, O / IND249 / 99, O / IND210 / 99, O / IND208 / 99, O / IND207 / 99, O / IND205 / 99, O / IND185 / 99, O / IND175 / 99, O / IND170 / 97, O / IND164 / 99, O / IND160 / 99, O / IND153 / 99, O / IND148 / 99, O / IND146 / 99, O / SKR / 2000, A22 / India / 17 / 77, O / IND / R2 / 1975 and any combination thereof.

18. The vaccine according to any one of claims 1-17, wherein the antigen is an inactivated foot-and-mouth disease virus.

19. The vaccine according to claim 17, wherein the inactivated foot-and-mouth disease virus is a recombinant virus.

20. The vaccine according to claim 18, wherein the recombinant foot-and-mouth disease virus does not contain a functional leader protein.

21. The vaccine according to claim 18 or 19, wherein the recombinant foot-and-mouth disease virus additionally contains DIVA markers.

22. The vaccine according to claim 19, wherein the recombinant foot-and-mouth disease virus additionally contains one or more deletion sequences as negative markers.

23. The vaccine of claim 19, wherein the recombinant foot-and-mouth disease virus further comprises one or more mutations in the capsid-encoding sequences that induce thermostability.

24. The vaccine according to any one of claims 19-23, wherein the recombinant foot-and-mouth disease virus expresses the capsid of a heterologous strain of foot-and-mouth disease.

25. The vaccine according to claim 24, wherein the heterologous strain of foot-and-mouth disease is a strain of serotype A, or serotype O, or serotype Asia, or serotype C, or serotype SAT1, or serotype SAT2, or serotype SAT3.

26. The vaccine according to claim 25, wherein the heterologous strain of foot-and-mouth disease is a strain of serotype A, or serotype O, and / or serotype Asia1.

27. The vaccine according to claim 25, wherein the heterologous strain of foot-and-mouth disease is a strain of serotype A, or serotype O, and / or serotype C.

28. The vaccine according to claim 25, wherein the heterologous strain of foot-and-mouth disease is a strain of serotype SAT1, serotype SAT2 and / or serotype SAT3.

29. The vaccine according to any one of claims. 24-28, wherein the heterologous strain is selected from a group consisting of O1 Manisa, O1 BFS or Campos, Asia 1 Shamir, A Iran '96, A22 Iraq, SAT2 Saudi Arabia, A10-61, A5, A12, A24 / Cruzeiro, C3 / Indaial, O11, C-Santa, Pau, C-C5 A22 / 550 / Azerbaijan / 65, SAT1-SAT3, A, A / TNC / 71 / 94, A / IND / 2 / 68, A / IND / 3 / 77, A / IND / 5 / 68, A / IND / 7 / 82, A / IND / 16 / 82, A / IND / 17 / 7 / 8 / 8, A / IND / 7 / 17, A / IND / 19 / 76, A / IND / 20 / 82, A / IND / 22 / 82, A / IND / 25 / 81, A / IND / 26 / 82, A / IND / 54 / 79, A / IND / 57 / 79, A / IND / 73 / 79, A / IND / 85 / 79, A / IND / 8 / 6,7 A / APA / 25 / 84, A / APN / 41 / 84, A / APS / 44 / 05, A / APS / 50 / 05, A / APS / 55 / 05, A / APS / 66 / 05, A / APS / 68 / 05, A / BIM / 46 / 95, A / GUM / 33 / 84 / ORS / 84,6 A / ORS / 75 / 88, A / TNAn / 60 / 947 / Asia / 1, A / IRN / 05, Asia / IRN / 05, O / HK / 2001, 0 / UKG / 3952 / 2001, O / UKG / 4141 / 2001, Asia 1 / HNK / CHA / XK / 75, HK / XJ, O / UKG / 7039 / 2001, O / UKG / 9161 / 2001, O / UKG / 7299 / 2001, O / UKG / 4014 / 2001, O / UKG / 4998 / 2001, O / UKG / 9443 / 2001, O / UKG / 9443 / 2001, O / UKG / 7017 / 2001 O / UKG / 5681 / 2001, O / ES / 2001, HKN / 2002, O5India, O / BKF / 2 / 92, K / 37 / 84 / A, KEN / 1 / 76 / A, GAM / 51 / 98 / A,A10 / Holland, O / KEN / 1 / 91, O / IND49 / 97, O / IND65 / 98, O / IND64 / 98, O / IND48 / 98, O / IND47 / 98, O / IND82 / 97, O / IND81 / 99, O / IND81 / 98, O / IND79 / 97, O / IND78 / 97, O / IND75 / 97, O / IND74 / 97, O / IND70 / 97, O / IND66 / 98, O / IND63 / 97, O / IND61 / 97, O / IND57 / 98, O / IND56 / 98, O / IND55 / 98, O / IND54 / 98, O / IND469 / 98, O / IND465 / 97, O / IND464 / 97, O / IND424 / 97, O / IND423 / 97, O / IND420 / 97, O / IND414 / 97, O / IND411 / 97, O / IND410 / 97, O / IND409 / 97, O / IND407 / 97, O / IND399 / 97, O / IND39 / 97, O / IND391 / 97, O / IND38 / 97, O / IND384 / 97, O / IND380 / 97, O / IND37 / 97, O / IND352 / 97, O / IND33 / 97, O / IND31 / 97, O / IND296 / 97, O / IND23 / 99, O / IND463 / 97, O / IND461 / 97, O / IND427 / 98, O / IND28 / 97, O / IND287 / 99, O / IND285 / 99, O / IND282 / 99, O / IND281 / 97, O / IND27 / 97, O / IND278 / 97, O / IND256 / 99, O / IND249 / 99, O / IND210 / 99, O / IND208 / 99, O / IND207 / 99, O / IND205 / 99, O / IND185 / 99, O / IND175 / 99, O / IND170 / 97, O / IND164 / 99, O / IND160 / 99, O / IND153 / 99, O / IND148 / 99, O / IND146 / 99, O / SKR / 2000, A22 / India / 17 / 77, O / IND / R2 / 75 and any combination thereof.

30. The vaccine of any one of claims 17-28, wherein the foot-and-mouth disease virus is present in an amount of at least 4 μg per dose per strain.

31. The vaccine of any one of claims 17-29, wherein the foot-and-mouth disease virus is present in an amount of at least 8 μg per dose per strain.

32. The vaccine of any one of claims 17-30, wherein the foot-and-mouth disease virus is present in an amount of about 10 mcg per dose per strain.

33. The vaccine according to any one of paragraphs 1-32, wherein the ruminant animal is cattle.

34. The vaccine according to any one of paragraphs 1-33, wherein the ruminant animal is negative for foot and mouth disease.