US2018228887A1PendingUtilityA1

Compositions, methods of administration and uses for trivalent dengue virus formulations

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Assignee: TAKEDA VACCINES INCPriority: Dec 14, 2012Filed: Dec 15, 2017Published: Aug 16, 2018
Est. expiryDec 14, 2032(~6.4 yrs left)· nominal 20-yr term from priority
A61K 2039/5256A61K 39/12A61K 2039/5254A61P 31/14A61P 37/04A61K 2039/70A61K 45/06C12N 2770/24134Y02A50/386Y02A50/30
56
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Claims

Abstract

Embodiments of the present invention report compositions and methods for vaccinating a subject using trivalent dengue virus vaccine compositions. In some embodiments, more than one vaccine composition may be administered to a subject in different anatomical locations in order to induce a rapid response to at least three of four dengue virus serotypes. In certain embodiments, administration of a trivalent dengue virus vaccine composition can be combined with administration of a monovalent dengue virus vaccine composition.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 - 18  (canceled) 
     
     
         19 . A trivalent dengue virus immunogenic composition comprising, at least one dengue-dengue chimera and at least one live, attenuated dengue virus in a combination wherein three dengue virus serotypes of dengue-1, dengue-2, dengue-3 and dengue-4 are represented in the immunogenic composition and pharmaceutically acceptable excipient, 
     
     
         20 . The immunogenic composition according to  claim 19 , wherein the at least one dengue-dengue chimera comprises a dengue-4 chimera. 
     
     
         21 . The immunogenic composition according to  claim 20 , wherein the dengue-4 chimera has a live, attenuated dengue-2 backbone. 
     
     
         22 . The immunogenic composition according to  claim 20 , wherein the at dengue-4 chimera concentration in the immunogenic composition is at least one log higher than at least one other dengue virus serotype represented in the immunogenic composition. 
     
     
         23 . The immunogenic composition according to  claim 19 , wherein the immunogenic composition is formulated for intradermal (ID), subcutaneous (SC), or intramuscular (IM) administration to a subject. 
     
     
         24 . A kit comprising the composition according to  claim 19 . 
     
     
         25 . A vaccine kit comprising;
 at least a first trivalent immunogenic composition against dengue virus comprising at least three dengue virus serotypes;   at least a second immunogenic composition comprising a single dengue-dengue chimera or a single live, attenuated dengue virus; and   at least two containers for the immunogenic compositions.   
     
     
         26 . The kit according to  claim 25 , wherein the trivalent dengue virus immunogenic composition comprises a mixture of three different dengue virus comprising dengue-1, dengue-2, dengue-3 and dengue-4. 
     
     
         27 . The kit according to  claim 26 , wherein the trivalent dengue virus immunogenic composition comprises a live, attenuated dengue-2 and a dengue-dengue chimera of dengue-1, dengue-3 or dengue-4. 
     
     
         28 . The kit according to  claim 25 , wherein the trivalent dengue virus immunogenic composition comprises a mixture of three or more different live, attenuated dengue viruses, wherein the mixture comprises at least three dengue virus serotypes comprising dengue-dengue chimeras, wherein the dengue-dengue chimeras comprise dengue virus structural proteins on an attenuated dengue-2 virus backbone, and one or more structural elements of dengue-1, dengue-2, dengue-3 or dengue-4, and one or more structural or non-structural elements of a live, attenuated dengue virus. 
     
     
         29 . The kit according to  claim 28 , wherein the second dengue immunogenic composition comprises a live, attenuated dengue virus immunogenic composition comprising a single live, attenuated dengue virus or a single dengue-dengue chimera. 
     
     
         30 . The kit according to  claim 25 , wherein a dengue-dengue chimera comprises a dengue-4 chimera on a dengue-2 backbone. 
     
     
         31 . The kit according to  claim 30 , wherein the dengue-4 chimera concentration is 2 to 100,000 fold higher concentration than at least one other dengue virus serotype. 
     
     
         32 . The kit according to  claim 25 , wherein the trivalent immunogenic composition comprises dengue-1, dengue-2, and dengue-3; dengue-1, dengue-3, and dengue-4; dengue-1, dengue-2, and dengue-4; or dengue-2, dengue-3 and dengue-4. 
     
     
         33 . The kit according to  claim 32 , wherein the trivalent dengue virus immunogenic compositions comprise unequivalent distribution of the three dengue virus serotypes in the immunogenic composition where concentration of one serotype can vary from 2 to 100,000 fold compared to another. 
     
     
         34 . The kit according to  claim 25 , wherein dengue-2 is present as a live, attenuated dengue-2 in the trivalent immunogenic formulation. 
     
     
         35 . The kit according to  claim 34 , wherein the live, attenuated dengue-2 virus is strain PDK-53.

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