US2019183999A1PendingUtilityA1

Developments in meningococcal outer membrane vesicles

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Assignee: GLAXOSMITHKLINE BIOLOGICALS SAPriority: Sep 10, 2010Filed: Dec 13, 2018Published: Jun 20, 2019
Est. expirySep 10, 2030(~4.1 yrs left)· nominal 20-yr term from priority
Inventors:Davide SerrutoMariagrazia PizzaIsabel Delany
A61K 2039/523A61K 39/095C12N 1/20C07K 14/22C12Y 205/01072C12N 9/1085C12N 1/38
63
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Claims

Abstract

A first aspect of the invention provides meningococcal outer membrane vesicles in which NHBA is over-expressed. A second aspect of the invention provides meningococcal outer membrane vesicles in which NadA is over-expressed. A third aspect of the invention provides a panel of bacterial strains, each member of which is isogenic except for a single gene which in each strain encodes a different variant antigen of interest.

Claims

exact text as granted — not AI-modified
1 . Meningococcal outer membrane vesicles in which NHBA is over-expressed. 
     
     
         2 . A meningococcus which over-expresses NHBA. 
     
     
         3 . The meningococcus of  claim 2 , which also over-expresses fHbp. 
     
     
         4 . A meningococcus which expresses NHBA, wherein the meningococcus is isogenic with a parental strain, except for a genetic modification which causes the meningococcus to express more NHBA than the parental strain. 
     
     
         5 . The meningococcus of  claim 4 , which includes (i) a gene under the control of a promoter which does not control that gene in the parental strain and/or (ii) a knockout of a gene which is found in the parental strain. 
     
     
         6 . The meningococcus of  claim 2 , wherein expression of NHBA is controlled by an inducible or constitutive promoter, and wherein the promoter optionally includes a CREN. 
     
     
         7 . The meningococcus of  claim 2 , wherein the meningococcus does not express NadR. 
     
     
         8 . The meningococcus of  claim 2 , wherein the bacterium also expresses more fHbp than the parental strain. 
     
     
         9 . The meningococcus of  claim 2 , wherein expression of NHBA is controlled by a strong promoter, NadR is knocked out, and the strain expresses a constitutively active mutant FNR. 
     
     
         10 . The meningococcus of  claim 2 , wherein expression of NHBA is controlled by a strong promoter, expression of fHbp is controlled by a strong promoter, and NadR is knocked out. 
     
     
         11 . The meningococcus of  claim 2 , wherein the bacterium has a knockout of LpxL1. 
     
     
         12 . The meningococcus of  claim 2 , wherein the bacterium does not express an active MltA. 
     
     
         13 . The meningococcus of  claim 2 , wherein the bacterium does not express PorA. 
     
     
         14 . The meningococcus of  claim 2 , wherein the bacterium does not express FrpB. 
     
     
         15 . The meningococcus of  claim 2 , in serogroup B. 
     
     
         16 . The meningococcus of  claim 2 , in immunotype L3. 
     
     
         17 . Outer membrane vesicles prepared from the meningococcus of  claim 2 . 
     
     
         18 . A process for preparing a meningococcal strain suitable for OMV preparation, comprising steps of (i) choosing a starting strain which expresses NHBA; and (ii) modifying the starting strain to increase the amount of NHBA which it expresses. 
     
     
         19 . A process for preparing a meningococcal strain suitable for OMV preparation, comprising steps of (i) choosing a starting strain which expresses a first amount of NHBA when grown in specific culture conditions, then (ii) modifying the starting strain to provide a modified strain, wherein the modified strain expresses a second amount of NHBA when grown in the same specific culture conditions, wherein the second amount is higher than the first amount. 
     
     
         20 . The process of  claim 18 , including a step (iii) culturing the modified bacteria obtained in step (ii) to provide a bacterial culture. 
     
     
         21 . (canceled) 
     
     
         22 . A process for preparing a meningococcal vesicle, comprising a step of treating a bacterial culture obtained by the process of  claim 20  such that its outer membrane forms vesicles. 
     
     
         23 . Outer membrane vesicles prepared by the process of  claim 22 . 
     
     
         24 . An immunogenic pharmaceutical composition comprising the vesicles of  claim 1 . 
     
     
         25 . The composition of  claim 24 , including one or more capsular saccharides from meningococci. 
     
     
         26 . The composition of  claim 24 , including an antigen from Streptococcus pneumoniae. 
     
     
         27 . A method for raising an immune response in a mammal, comprising administering a composition of  claim 24  to the mammal.

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