US2005169943A1PendingUtilityA1

Neisserial vaccine compositions and methods

48
Priority: Feb 22, 1999Filed: Feb 14, 2005Published: Aug 4, 2005
Est. expiryFeb 22, 2019(expired)· nominal 20-yr term from priority
Inventors:Andrew RobinsonAndrew Richard GorringeMichael John HudsonPhilippa BracegirdleJohn KrollPaul LangfordSteven Anthony Rochford WebbKeith CartwrightCliona O'Dwyer
A61K 2039/505A61K 39/095A61P 31/04A61K 2039/521A61K 2039/523Y10S530/825C07K 14/22A61K 39/12A61K 39/165
48
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Cited by
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References
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Claims

Abstract

Methods and compositions for the treatment of microbial infection, and in particular meningococcal disease, comprise a commensal Neisseria or an extract of a commensal Neisseria. Further methods and compositions comprise commensal Neisseria which express genes from virulent strains of Neisseria and/or heterologous gene products from non-Neisserial sources. Such compositions are used in vaccine preparations for the treatment of microbial infection.

Claims

exact text as granted — not AI-modified
1 - 38 . (canceled)  
     
     
         39 . A method of preparing a vaccine comprising: 
 (a) isolating an outer membrane preparation, immunogenic component, or extract thereof, from commensal  Neisseria;  and    (b) formulating the preparation for use as a vaccine.    
     
     
         40 . The method of  claim 39  wherein step (b) comprises: 
 (b1) admixing said outer membrane preparation, immunogenic component or extract with a pharmaceutically acceptable carrier; and/or    (b2) admixing said outer membrane preparation, immunogenic component or extract with a pharmaceutically acceptable adjuvant.    
     
     
         41 . The method according to  claim 40  comprising: 
 (a) isolating an outer membrane preparation, immunogenic component, or extract thereof, from commensal  Neisseria;  and    (b1) admixing said outer membrane preparation, immunogenic component or extract with a pharmaceutically acceptable carrier; and    (b2) admixing said outer membrane preparation, immunogenic component or extract with a pharmaceutically acceptable adjuvant.    
     
     
         42 . A method according to  claim 39  wherein said outer membrane preparation comprises outer membrane vesicles.  
     
     
         43 . A method according to  claim 39  wherein said commensal  Neisseria  is selected from:  N. Lactamica; N. cinerea; N. elongata; N. flavescens; N. polysaccharea; N. sicca  and  N. subflava.    
     
     
         44 . A method according to  claim 43  wherein said commensal  Neisseria  is  N. lactamica.    
     
     
         45 . A method according to  claim 39  wherein the immunogenic component or extract comprises a protein fraction of molecular weight less than 40 kDa.  
     
     
         46 . A method according to  claim 39  wherein the immunogenic component or extract comprises a protein fraction of molecular weight more than 40 kDa and less than 67 kDa.  
     
     
         47 . A method according to  claim 39  wherein the immunogenic component or extract comprises a protein fraction of molecular weight more than 67 kDa.  
     
     
         48 . A method according to  claim 39  wherein said outer membrane preparation is derived from  Neisseria  expressing a heterologous gene product and wherein said heterologous gene product is present in said outer membrane preparation.  
     
     
         49 . A method according to  claim 48  where said heterologous gene product is from pathogenic  Neisseria.    
     
     
         50 . A method according to  claim 39  wherein prior to isolating said outer membrane preparation, immunogenic component, or extract thereof the  Neisseria  are cultured in the absence of iron.  
     
     
         51 . A method according to  claim 39  further comprising combining said outer membrane preparation or immunogenic component, or extract thereof with a heterologous gene product.  
     
     
         52 . A method according to  claim 39  further comprising the step of supplementing said outer membrane preparation of a commensal  Neisseria  or an isolated immunogenic component, or extract thereof with one or more antigens from  Neisseria  species.  
     
     
         53 . A method according to  claim 52  wherein said antigen is selected from: Cu—Zn SOD-, the 22 kD NspA, porins, gonorrhoeal antigens or transferrin binding proteins.  
     
     
         54 . A method of vaccination comprising administering an effective amount of an outer membrane preparation of a commensal  Neisseria  or an isolated immunogenic component, or extract thereof to an individual.  
     
     
         55 . A method according to  claim 54  wherein said vaccination is against microbial disease.  
     
     
         56 . A method according to  claim 55  where said vaccination is against Neisserial disease.  
     
     
         57 . A method according to  claim 54  wherein said administering is selected from the group consisting of: orally; intravenously; subcutaneously; intraperitoneally; intramuscularly; intranasally; or intradermally administering.  
     
     
         58 . A method according to  claim 54  wherein said outer membrane preparation comprises outer membrane vesicles.  
     
     
         59 . A method according to  claim 54  wherein said commensal  Neisseria  is selected from:  N. Lactamica; N. cinerea; N. elongata; N. flavescens; N. polysaccharea; N. sicca  and  N. subflava.    
     
     
         60 . A method according to  claim 59  wherein said commensal  Neisseria  is  N. lactamica.    
     
     
         61 . A method according to  claim 54  wherein the immunogenic component or extract comprises a protein fraction of molecular weight less than 40 kDa.  
     
     
         62 . A method according to  claim 54  wherein the immunogenic component or extract comprises a protein fraction of molecular weight more than 40 kDa and less than 67 kDa.  
     
     
         63 . A method according to  claim 54  wherein the immunogenic component or extract comprises a protein fraction of molecular weight more than 67 kDa.  
     
     
         64 . A method according to  claim 54  wherein said outer membrane preparation is derived from  Neisseria  expressing a heterologous gene product and wherein said heterologous gene product is present in said outer membrane preparation.  
     
     
         65 . A method according to  claim 64  where said heterologous gene product is from pathogenic  Neisseria.    
     
     
         66 . A method of  claim 54  further wherein said outer membrane preparation or isolated immunogenic component, or extract thereof is combined with a heterologous gene product.  
     
     
         67 . A method according to  claim 54  wherein said outer membrane preparation of a commensal  Neisseria  or isolated immunogenic component, or extract thereof is supplemented with one or more antigens from  Neisseria  species.  
     
     
         68 . A method according to  claim 67  wherein said antigen is selected from: Cu—Zn SOD-, the 22 kD NspA, porins, gonorrhoeal antigens or transferrin binding proteins.  
     
     
         69 . A method according to  claim 54 , wherein said outer membrane preparation, isolated immunogenic component or extract thereof comprises a pharmaceutically acceptable carrier and/or a pharmaceutically acceptable adjuvant.

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