US2018008691A1PendingUtilityA1

Compositions and methods for rapid immunization against dengue virus

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Assignee: TAKEDA VACCINES INCPriority: Jun 1, 2009Filed: Jun 16, 2017Published: Jan 11, 2018
Est. expiryJun 1, 2029(~2.9 yrs left)· nominal 20-yr term from priority
A61K 45/06A61K 2039/545A61K 2039/54C12N 2770/24134A61K 2039/5254A61K 39/12A61K 2039/70Y02A50/30
60
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Claims

Abstract

Embodiments of the present invention report compositions and methods for vaccinating a subject against all dengue virus serotypes. In some embodiments, multiple vaccine compositions may be administered to a subject in different anatomical locations in order to induce a rapid response to all dengue virus serotypes. In certain embodiments, administration of two or more vaccine compositions to a subject against all dengue virus serotypes may include two or more routes of administration.

Claims

exact text as granted — not AI-modified
What is claimed: 
     
         1 - 24 . (canceled) 
     
     
         25 . A method for inducing an immune response in a subject against three or more dengue virus serotypes, the method comprising:
 administering a first immunogenic composition of three or more live, attenuated dengue viruses, the composition comprising at least one non-chimeric live, attenuated dengue-2 virus and at least one dengue-dengue chimera having a live, attenuated dengue-2 virus backbone; and   administering a second immunogenic composition of three or more live, attenuated dengue viruses, the composition comprising at least one non-chimeric live, attenuated dengue-2 virus and at least one dengue-dengue chimera having a live, attenuated dengue-2 virus backbone;   wherein the first immunogenic composition and the second immunogenic composition are administered at the same anatomical location on the same day to the subject; and   inducing an immune response in the subject against the three or more dengue virus serotypes.   
     
     
         26 . The method of  claim 25 , wherein the first immunogenic composition and the second immunogenic composition comprise different compositions. 
     
     
         27 . (canceled) 
     
     
         28 . The method of  claim 25 , wherein the first immunogenic composition comprises three or four dengue virus serotypes at predetermined ratios. 
     
     
         29 . The method of  claim 25 , wherein the first immunogenic composition comprises a tetravalent formulation of all four dengue virus serotypes. 
     
     
         30 - 31 . (canceled) 
     
     
         32 . The method of  claim 25 , wherein the at least one dengue-dengue chimera of a live, attenuated dengue virus comprises non-structural proteins from at least one dengue virus serotype and pre-membrane and envelope proteins from at least a second dengue virus serotype. 
     
     
         33 . The method of  claim 25 , wherein the at least one dengue-dengue chimera of a live, attenuated dengue virus is selected from dengue-2/dengue-1, dengue-2/dengue-3, and dengue-2/dengue-4, wherein dengue-2 is the backbone and dengue-1, dengue-3 or dengue-4 contribute pre-membrane and envelope proteins. 
     
     
         34 . The method of  claim 25 , wherein the serotype, dengue-4, is present in at least the first composition at a concentration about 1.5 times greater than any other dengue serotype. 
     
     
         35 . The method of  claim 34 , wherein dengue-4 is present in at least the first composition and is at least about 10 times greater than dengue-2. 
     
     
         36 . The method of  claim 25 , further comprising administering to the subject at least one additional immunogenic agent. 
     
     
         37 . The method of  claim 25 , wherein the first immunogenic composition and the second immunogenic composition are administered to the subject subcutaneously. 
     
     
         38 . The method of  claim 25 , further comprising administering at least one additional booster administration of a formulation of a live, attenuated dengue vaccine after administration of the compositions of  claim 25 . 
     
     
         39 . The method of  claim 38 , wherein the at least one additional booster administration is administered subcutaneously to the subject after administration of the compositions of  claim 25 . 
     
     
         40 . The method of  claim 25 , wherein at least one additional subcutaneous administration of the first immunogenic composition or the second immunogenic composition is administered to the subject after the initial administration. 
     
     
         41 . A method for inducing an immune response in a subject against three or more dengue virus serotypes, the method comprising:
 administering a first immunogenic composition of a monovalent live, attenuated dengue virus;   administering a second immunogenic composition of three or more live, attenuated dengue viruses, the composition comprising at least one non-chimeric live, attenuated dengue-2 virus and at least one dengue-dengue chimera having a live, attenuated dengue-2 virus backbone; and;   wherein the first immunogenic composition and the second immunogenic composition are administered at two or more anatomical locations consecutively on the same day to the subject; and   inducing an immune response in the subject against the three or more dengue virus serotypes.   
     
     
         42 - 43 . (canceled) 
     
     
         44 . The method of  claim 41 , wherein the second immunogenic composition comprises at least three dengue virus serotypes at predetermined ratios. 
     
     
         45 . The method of  claim 41 , wherein the second immunogenic composition comprises a tetravalent formulation of all four dengue virus serotypes. 
     
     
         46 . The method of  claim 41 , wherein the two or more anatomical locations comprise different anatomical locations on different body parts of the subject. 
     
     
         47 . The method of  claim 41 , wherein the two or more anatomical locations comprise different anatomical locations on the same body part of the subject. 
     
     
         48 . The method of  claim 41 , wherein the at least one dengue-dengue chimera of a live, attenuated dengue virus comprises non-structural proteins from at least one dengue virus serotype and pre-membrane and envelope proteins from at least a second dengue virus serotype. 
     
     
         49 . The method of  claim 41 , wherein the at least one dengue-dengue chimera of a live, attenuated dengue virus is selected from dengue-2/dengue-1, dengue-2/dengue-3, and dengue-2/dengue-4, wherein dengue-2 is the backbone and dengue-1, dengue-3 or dengue-4 contribute pre-membrane and envelope proteins. 
     
     
         50 . The method of  claim 41 , wherein the serotype, dengue-4, is present in at least the second composition at a concentration about 1.5 times greater than any other dengue serotype. 
     
     
         51 . The method of  claim 50 , wherein dengue-4 is present in at least the second composition and is at least about 10 times greater than dengue-2. 
     
     
         52 . The method of  claim 41 , further comprising administering to the subject at least one additional immunogenic agent. 
     
     
         53 . The method of  claim 41 , wherein the first immunogenic composition and the second immunogenic composition are administered to the subject subcutaneously. 
     
     
         54 . The method of  claim 41 , further comprising administering at least one additional booster administration of a formulation of a live, attenuated dengue vaccine after administration of the compositions of claim  1 . 
     
     
         55 . The method of  claim 54 , wherein the at least one additional booster administration is administered subcutaneously to the subject after administration of the compositions of claim  1 . 
     
     
         56 . (canceled) 
     
     
         57 . A vaccine kit for carrying out the method of  claim 41 , the kit comprising:
 an immunogenic composition of three or more live, attenuated dengue viruses, the composition comprising at least one non-chimeric live, attenuated dengue virus and at least one dengue-dengue chimera of a live, attenuated dengue virus; and   an immunogenic composition of one live, attenuated dengue virus, the composition comprising one non-chimeric live, attenuated dengue virus or one dengue-dengue chimera of a live, attenuated dengue virus;   at least two devices capable of administering the compositions to a subject.   
     
     
         58 . The kit of  claim 57 , wherein the immunogenic compositions comprise different formulations. 
     
     
         59 . The kit of  claim 57 , further comprising at least one immunogenic agent. 
     
     
         60 . The kit of  claim 57 , wherein the immunogenic composition of three or more live, attenuated dengue viruses comprises a tetravalent composition of all four dengue virus serotypes. 
     
     
         61 . The method of  claim 25 , wherein the first immunogenic composition and the second immunogenic composition comprise the same composition. 
     
     
         62 . The method of  claim 41 , wherein the monovalent live, attenuated dengue virus comprises dengue serotype 4.

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