Non-typeable haemophilus influenzae vaccines and their uses

Abstract

Provided are non-typeable Haemophilus influenzae vaccines useful for the treatment of chronic obstructive pulmonary disease and asthma in a patient. In certain aspects, the vaccine is a monobacterial vaccine. Bacterial strains for use in the vaccines of the present application are also provided.

1 - 39 . (canceled) 
     
     
         40 . A pharmaceutical composition for the treatment of airways diseases, comprising an effective amount of killed non-typeable  Haemophilus influenzae , or an immunogenic outer membrane fraction or outer membrane protein component of the non-typeable  Haemophilus influenzae , the non-typeable  Haemophilus influenzae  comprising isolate NTHi-164 deposited with the National Measurement Institute (“NMI”) and assigned deposit no. V08/021002. 
     
     
         41 . The composition of  claim 40 , wherein the composition does not contain killed non-typeable  Haemophilus influenzae  isolate NTHi-167 deposited with the NMI and assigned deposit no. V08/021003, or an immunogenic outer membrane fraction or outer membrane protein component of NTHi-167. 
     
     
         42 . The composition of  claim 40 , wherein the composition is in a unit dosage form for oral administration. 
     
     
         43 . The composition of  claim 42 , wherein the dosage form comprises a core containing the killed non-typeable  Haemophilus influenzae  or said outer membrane fraction or protein component, and an enteric coating surrounding the core. 
     
     
         44 . The composition of  claim 40  comprising isolate NTHi-164. 
     
     
         45 . The composition of  claim 40 , wherein the non-typeable  Haemophilus influenzae  is formalin killed. 
     
     
         46 . The composition of  claim 40  comprising the outer membrane fraction or protein component of isolate NTHi-164. 
     
     
         47 . The composition of  claim 40 , wherein the membrane fraction comprises an outer membrane protein fraction of isolate NTHi-164. 
     
     
         48 . The composition of  claim 40  which is in the form of a capsule, tablet, or enterically coated granules. 
     
     
         49 . The composition of  claim 40  comprising from about 10 8  to about 10 13  killed colony forming units of said non-typeable  Haemophilus influenzae , or said outer membrane fraction or protein component comprising from about 10 8  to about 10 13  killed colony forming units of said non-typeable  Haemophilus influenzae.    
     
     
         50 . The composition of  claim 43  which further comprising a subenteric coating between said core and said enteric coating. 
     
     
         51 . The composition of  claim 49  which further comprises a film coating as its outermost layer. 
     
     
         52 . The composition of  claim 40  which is a monobacterial vaccine. 
     
     
         53 . The composition of  claim 40  which is a polybacterial vaccine. 
     
     
         54 . A method of treating a patient with a chronic mucosal disease, comprising administering to the patient an effective amount of a composition according to  claim 40 . 
     
     
         55 . The method of  claim 54 , wherein the effective amount is one to three unit doses of the composition administered daily for two to five consecutive days, each unit dose comprising from about 10 8  to 10 13  killed colony forming units of said non-typeable  Haemophilus influenzae , or said membrane fraction or protein component comprising from about 10 8  to 10 13  killed colony forming units of said non-typeable  Haemophilus influenzae.    
     
     
         56 . The method of  claim 54 , further comprising repeating said administration after a three to five week interval. 
     
     
         57 . The method of  claim 56 , wherein said administration is repeated twice, each administration being repeated at a three- to five-week period following the preceding administration. 
     
     
         58 . The method of  claim 54 , wherein the chronic mucosal disease is selected from the group consisting of chronic obstructive pulmonary disease, cystic fibrosis related disease, chronic bronchitis and emphysema. 
     
     
         59 . A method of treating asthma, comprising administering to a patient in need thereof an effective amount of a composition according to  claim 40 . 
     
     
         60 . The method of  claim 59 , wherein the effective amount is one to three unit doses of the composition administered daily for two to five consecutive days, each unit dose comprising from about 10 8  to 10 13  killed colony forming units of said non-typeable  Haemophilus influenzae , or said membrane fraction or protein component comprising from about 10 8  to 10 13  killed colony forming units of said non-typeable  Haemophilus influenzae.    
     
     
         61 . The method of  claim 59 , further comprising repeating said administration after a three to five week interval. 
     
     
         62 . The method of  claim 61 , wherein said administration is repeated twice, each administration being repeated at a three- to five-week period following the preceding administration. 
     
     
         63 . The method according to  claim 59 , wherein the asthma is intrinsic asthma. 
     
     
         64 . Non-typeable  Haemophilus influenzae  isolate NTHi-164, deposited with the National Measurement Institute (“NMI”) and assigned deposit no. V08/021002, or an immunogenic outer membrane fraction or outer membrane protein component of NTHi-164, or a subculture thereof.