Immunogenic composition for use in vaccination against staphylococcei

Abstract

The present application relates to immunogenic compositions comprising a mixture of staphylococcal antigens which combines antigen having different functions, for instance, combinations including a staphylococcal extracellular component binding protein and a staphylococcal transporter protein or a staphylococcal extracellular component binding protein and a staphylococcal regulator of virulence or toxin or a staphylococcal transporter protein and a staphylococcal regulator of virulence or toxin. Vaccines, methods of treatment, uses of and processes to make a staphylococcal vaccine are also described.

1 . An immunogenic composition comprising at least two different proteins or immunogenic fragments thereof selected from at least two groups of proteins or immunogenic fragments selected from the following groups:
 Group a) at least one  staphylococcal  extracellular component binding protein or immunogenic fragment thereof selected from the group consisting of SdrG, laminin receptor, EbhA, EbhB, Elastin binding protein (EbpS), EFB (FIB), SBI, autolysin, ClfA, SdrC, SdrH, Lipase GehD, FnbA, FnbB, Cna, ClfB, FbpA, Npase, IsaA/PisA, SsaA, EPB, SSP-1, SSP-2, HBP, Vitronectin binding protein, coagulase, and MAP;   Group b) at least one  staphylococcal  transporter protein or immunogenic fragment thereof selected from the group consisting of immunodominant ABC transporter, IsdA, IsdB, Mg2+ transporter, SitC and Ni ABC transporter;   Group c) at least one  staphylococcal  regulator of virulence, toxin or immunogenic fragment thereof selected from the group consisting of alpha toxin (Hla), alpha toxin H35R mutant, alpha toxin H35L mutant and RNA III activating protein (RAP).   
     
     
         2 . The immunogenic composition of  claim 1  wherein at least one protein or immunogenic fragment is selected from group a). 
     
     
         3 . The immunogenic composition of  claim 1  wherein at least one protein or immunogenic fragment is selected from group b). 
     
     
         4 . The immunogenic composition of  claim 1  wherein at least one protein or immunogenic fragment is selected from group c). 
     
     
         5 . The immunogenic composition of  claim 1   4  wherein at least one protein or immunogenic fragment is selected from group a), group b) and group c). 
     
     
         6 . The immunogenic composition of  claim 1  comprising at least one protein or immunogenic fragment from  S. Aureus.    
     
     
         7 . The immunogenic composition of  claim 1  comprising at least one protein or immunogenic fragment from  S. Epidermidis.    
     
     
         8 . The immunogenic composition of  claim 1  further comprising a PIA polysaccharide or oligosaccharide. 
     
     
         9 . The immunogenic composition of  claim 1  further comprising type V and/or type VIII capsular polysaccharide or oligosaccharide from  S. Aureus.    
     
     
         10 . The immunogenic composition of  claim 1  further comprising Type I, and/or Type II and/or Type III capsular polysaccharide or oligosaccharide from  S. Epidermidis.    
     
     
         11 - 12 . (canceled) 
     
     
         13 . The immunogenic composition of  claim 8  wherein a  staphylococcal  capsular polysaccharide is conjugated to a protein carrier. 
     
     
         14 . (canceled) 
     
     
         15 . The immunogenic composition of  claim 13  wherein the protein carrier is selected from the group consisting of tetanus toxic, diphtheria toxic, CRM197,  Haemophilus influenzae  protein D, pneumolysin and alpha toxic. 
     
     
         16 . The immunogenic composition of  claim 1  which is capable of generating an effective immune response against both  S. Aureus  and  S. Epidermidis.    
     
     
         17 . A vaccine comprising the immunogenic composition of  claim 1  and a pharmaceutically acceptable excipient. 
     
     
         18 . A method of making a vaccine comprising the steps of mixing antigens to make the immunogenic composition of  claim 1  and adding a pharmaceutically acceptable excipient. 
     
     
         19 . A method of preventing or treating  staphylococcal  infection comprising the step of administering the vaccine of  claim 17  to a patient in need thereof. 
     
     
         20 . (canceled) 
     
     
         21 . A method of preparing an immune globulin for use in prevention or treatment of  staphylococcal  infection comprising the steps of immunizing a recipient with the vaccine of  claim 17  and isolating the immune globulin from the recipient. 
     
     
         22 . An immune globulin prepared by the method of  claim 21 . 
     
     
         23 . A pharmaceutical composition comprising the immune globulin of  claim 22  and a pharmaceutically acceptable excipient. 
     
     
         24 . A method for treatment or prevention of  staphylococcal  infection comprising a step of administering to a patient an effective amount of the pharmaceutical composition of  claim 23 . 
     
     
         25 . (canceled) 
     
     
         26 . A pharmaceutical composition comprising two or more monoclonal antibodies or fragments thereof which are reactive against at least two constituents of the immunogenic composition of  claim 1  wherein the at least two constituents are selected from at least 2 of groups a), b), and c).