Immunogenic composition and vaccine for generating an immune response to norovirus

Abstract

An immunogenic composition comprising at least one Norovirus antigen and at least one adjuvant which is at least one B subunit of an AB 5 toxin such as cholera toxin subunit B (CTB) or the B subunit of heat-labile E. coli exotoxin LT (LTB).

1 . A method of preventing and/or treating norovirus infection and/or for reducing the severity of norovirus infection, said immunogenic composition comprising at least one norovirus antigen and at least one B subunit of an AB 5  toxin to a subject by parenteral administration of the immunogenic composition selected from intradermal, intramuscular and subcutaneous administration, wherein said B subunit is a B subunit of cholera toxin (CTB). 
     
     
         2 . The method according to  claim 1 , wherein said composition is free of the A subunit of said toxin. 
     
     
         3 . The method according to  claim 1 , wherein said B subunit is an adjuvant of said composition. 
     
     
         4 . The method according to  claim 1 , wherein said B subunit is an antigen, and said at least one norovirus antigen and said B subunit are components of a combination vaccine. 
     
     
         5 . The method according to  claim 1 , wherein said at least one norovirus antigen is or comprises a norovirus VP1 protein. 
     
     
         6 . The method according to  claim 1 , said immunogenic composition comprising an antigen of a genogroup I norovirus and an antigen of a genogroup II norovirus. 
     
     
         7 . The method according to  claim 1 , wherein said immunogenic composition comprises norovirus virus-like particles (norovirus VLPs) comprising or consisting of said at least one norovirus antigen. 
     
     
         8 . The method according to  claim 1 , wherein said immunogenic composition comprises VLPs of a genogroup I norovirus and VLPs of a genogroup II norovirus. 
     
     
         9 . The method according to  claim 1 , wherein said CTB is pentameric CTB. 
     
     
         10 . The method according to  claim 1 , said immunogenic composition comprising two or more genogroup II noroviral antigens, wherein a first VLP comprises or consists of a first genogroup II noroviral antigen and a second VLP comprises or consists of a second genogroup II noroviral antigen. 
     
     
         11 . The method according to  claim 1 , said immunogenic composition comprising a genotype 11.4 noroviral antigen and a genotype II.17 noroviral antigen. 
     
     
         12 . The method according to  claim 1 , said immunogenic composition comprising VLPs comprising or consisting of a genogroup I noroviral antigen, VLPs comprising or consisting of a genogroup 11 noroviral antigen, and CTB as an adjuvant. 
     
     
         13 . The method according to  claim 1 , said immunogenic composition comprising VLPs comprising or consisting of a genotype I.1 or 1.4 noroviral antigen, VLPs comprising or consisting of a genotype II.4 noroviral antigen, and CTB as an adjuvant. 
     
     
         14 . The method according to  claim 8 , said immunogenic composition comprising said genogroup I noroviral antigen and said genogroup II noroviral antigen in a mass ratio range of from 1:1 to 1:6, preferably of from 1:1.5 to 1:5, more preferably of from 1:2 to 1:4. 
     
     
         15 . The method according to  claim 1 , said composition not comprising an aluminum salt, such as aluminum hydroxide. 
     
     
         16 . The method according to  claim 1 , said method being for preventing and/or treating and/or for reducing the severity of norovirus infection in a mammal. 
     
     
         17 . A method for preventing and/or treating Norovirus infection and infection by a bacterial pathogen in a mammal, comprising administering to a subject an immunogenic composition comprising at least one noroviral antigen and a B subunit of a bacterial AB 5  toxin capable of generating an immune response against said bacterial pathogen, wherein said B subunit of a bacterial AB 5  toxin is a B subunit of cholera toxin (CTB). 
     
     
         18 . The method according to  claim 17 , comprising parenteral administration of the immunogenic composition, such as intradermal, intramuscular or subcutaneous administration. 
     
     
         19 . An anti-norovirus vaccine or a pharmaceutical composition, comprising the immunogenic composition as defined in  claim 1  and a pharmaceutically acceptable carrier. 
     
     
         20 . Combination vaccine for preventing and/or treating Norovirus infection and infection by a bacterial pathogen in a mammal, said vaccine comprising a noroviral antigen and a B subunit of a bacterial AB 5  toxin capable of generating an immune response against said bacterial pathogen, and a pharmaceutically acceptable carrier, wherein said B subunit of a bacterial AB 5  toxin is a B subunit of cholera toxin (CTB).