COMPOSITIONS, METHODS OF ADMINISTRATION AND USES FOR TRIVALENT DENGUE VIRUS FORMULATIONS
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.
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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.