US2016120972A1PendingUtilityA1

Inactivated dengue virus vaccine with aluminium-free adjuvant

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Assignee: GLAXOSMITHKLINE BIOLOG SAPriority: Feb 17, 2009Filed: Jan 11, 2016Published: May 5, 2016
Est. expiryFeb 17, 2029(~2.6 yrs left)· nominal 20-yr term from priority
Inventors:Benoit BarasDirk GheysenIsabelle KnottJean-Paul PrieelsJean-Francois Toussaint
A61P 37/04A61P 31/12A61P 31/14A61K 2039/55577A61K 2039/55566A61K 2039/55572A61K 2039/55511C12N 2770/24134A61K 39/12A61K 2039/55A61K 2039/55583A61K 2039/55555A61K 2039/5252C07K 14/00C07K 14/005A61K 39/39Y02A50/30
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Claims

Abstract

The present disclosure provides immunogenic compositions for the prevention and/or treatment of disease caused by dengue virus.

Claims

exact text as granted — not AI-modified
We claim: 
     
         1 . An immunogenic composition comprising at least one inactivated dengue virus antigen and an aluminum-free adjuvant, wherein the adjuvant comprises 3D-MPL and QS21 in a liposomal formulation. 
     
     
         2 . The immunogenic composition of  claim 1 , wherein the at least one inactivated dengue virus antigen is selected from the group consisting of a Dengue-1 virus antigen, a Dengue-2 virus antigen, a Dengue-3 virus antigen and a Dengue-4 virus antigen. 
     
     
         3 . The immunogenic composition of  claim 1 , wherein the at least one inactivated dengue virus antigen comprises a Dengue-2 virus antigen. 
     
     
         4 . The immunogenic composition of  claim 1 , wherein the at least one inactivated dengue virus antigen is an inactivated whole dengue virus. 
     
     
         5 . The immunogenic composition of  claim 2 , wherein the immunogenic composition comprises a Dengue-1 virus antigen, a Dengue-2 virus antigen, a Dengue-3 virus antigen and a Dengue-4 virus antigen. 
     
     
         6 . The immunogenic composition of  claim 1 , wherein the at least one inactivated dengue virus antigen is a purified inactivated whole dengue virus. 
     
     
         7 . The immunogenic composition of  claim 1  wherein the immunogenic composition comprises inactivated whole Dengue-1 virus, inactivated whole Dengue-2 virus, inactivated whole Dengue-3 virus and inactivated whole Dengue-4 virus. 
     
     
         8 . The immunogenic composition of  claim 1  wherein the immunogenic composition comprises purified inactivated whole Dengue-1 virus, purified inactivated whole Dengue-2 virus, purified inactivated whole Dengue-3 virus and purified inactivated whole Dengue-4 virus. 
     
     
         9 . The immunogenic composition of  claim 1 , wherein the adjuvant further comprises cholesterol. 
     
     
         10 . The immunogenic composition of  claim 1  or  claim 9 , wherein the adjuvant further comprises 1, 2-Dioleoyl-sn-Glycero-3-phosphocholine (DOPC). 
     
     
         11 . The immunogenic composition of  claim 1 , wherein the adjuvant comprises cholesterol, DOPC, 3D-MPL and QS21. 
     
     
         12 . The immunogenic composition of  claim 11 , wherein the adjuvant is formulated in a dose comprising:
 from about 0.1 to about 0.5 mg cholesterol,   from about 0.25 to about 2 mg DOPC,   from about 10 μg to about 100 μg 3D-MPL, and   from about 10 μg to about 100 μg QS21.   
     
     
         13 . The immunogenic composition of  claim 9 , wherein the ratio of cholesterol to QS21 is 5:1 (w/w). 
     
     
         14 . The immunogenic composition of  claim 9 , wherein the ratio of cholesterol to QS21 is 1:1 (w/w). 
     
     
         15 . The immunogenic composition of  claim 11 , wherein the adjuvant is formulated in a dose comprising:
 about 0.25 mg cholesterol,   about 1.0 mg DOPC,   about 50 μg 3D-MPL, and   about 50 μg QS21.   
     
     
         16 . A method for preventing, ameliorating or treating disease caused by dengue virus in a subject comprising: administering the immunogenic composition of  claim 1  to the subject. 
     
     
         17 . The method of  claim 9 , wherein the subject is under 5 years of age. 
     
     
         18 . The method of  claim 9 , wherein the subject is under 1 year of age.

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