Immunogenic composition, use and method of treatment

Abstract

The present invention relates to immunogenic compositions comprising an immunogenic polypeptide from Haemophilus influenzae or an immunogenic fragment thereof and/or an immunogenic polypeptide from Moraxella catarrhalis or an immunogenic fragment thereof, for use in the treatment or prevention of a recurrence of an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) resulting from a bacterial infection in a subject.

1 - 40 . (canceled) 
     
     
         41 . A combination therapy comprising:
 (i) one or more therapeutic agents selected from the group consisting of beta 2 -agonists, anticholinergics, methylxanthines, phosphodiesterase-4 (PDE-4) inhibitors and inhaled corticosteroids; and   (ii) an immunogenic composition comprising an immunogenic polypeptide from  Haemophilus influenzae  or an immunogenic fragment thereof and/or an immunogenic polypeptide from  Moraxella catarrhalis  or an immunogenic fragment thereof.   
     
     
         42 . (canceled) 
     
     
         43 . The combination therapy according to  claim 41 , comprising an anticholinergic as the therapeutic agent. 
     
     
         44 . The combination therapy according to  claim 41 , comprising two therapeutic agents: a beta 2 -agonist and an anticholinergic. 
     
     
         45 . The combination therapy according to  claim 41  comprising three therapeutic agents: a beta 2 -agonist, an anticholinergic and an inhaled corticosteroid. 
     
     
         46 . The combination therapy according to  claim 41  comprising two therapeutic agents: a beta 2 -agonist and an inhaled corticosteroid. 
     
     
         47 . The combination therapy according to  claim 41  comprising umeclidinium (e.g. umeclidinium bromide) as the anticholinergic, optionally at a dose of 62.5 mcg once daily. 
     
     
         48 . The combination therapy according to  claim 44  comprising vilanterol (e.g. vilanterol trifenatate) as the beta 2 -agonist, optionally at a dose of 25 mcg once daily. 
     
     
         49 . The combination therapy according to  claim 45  comprising fluticasone furoate as the inhaled corticosteroid, optionally at a dose of 100 mcg once daily. 
     
     
         50 . The combination therapy according to  claim 41 , wherein the one or more therapeutic agents are formulated as dry powder compositions for inhalation via a dry powder inhaler device. 
     
     
         51 . The combination therapy according to  claim 41  comprising an immunogenic composition comprising an immunogenic polypeptide from non-typeable  H. influenzae  (NTHi) or an immunogenic fragment thereof. 
     
     
         52 . The combination therapy according to  claim 41  comprising an immunogenic composition Protein D or an immunogenic fragment thereof, suitably an isolated immunogenic polypeptide with at least 70%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% to SEQ ID NO. 2. 
     
     
         53 . The combination therapy according to  claim 41  comprising an immunogenic composition Protein E or an immunogenic fragment thereof, suitably an isolated immunogenic polypeptide with at least 70%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% to SEQ ID NO. 5. 
     
     
         54 . The combination therapy according to  claim 41  comprising an immunogenic composition PilA or an immunogenic fragment thereof, suitably an isolated immunogenic polypeptide with at least 70%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% to SEQ ID NO. 7. 
     
     
         55 . The combination therapy according to  claim 41  comprising an immunogenic composition comprising Protein E and PilA, wherein Protein E and PilA are present as a fusion protein, suitably an isolated immunogenic polypeptide with at least 70%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% to SEQ ID NO. 9. 
     
     
         56 . The combination therapy according to  claim 41  comprising an immunogenic composition comprising an immunogenic polypeptide from  M. catarrhalis  or an immunogenic fragment thereof. 
     
     
         57 . The combination therapy according to  claim 41  comprising an immunogenic composition comprising UspA2 or an immunogenic fragment thereof. 
     
     
         58 . The combination therapy according to  claim 41  comprising an immunogenic composition comprising an immunogenic fragment of UspA2, suitably an isolated immunogenic polypeptide with at least 70%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% to a polypeptide selected from the group consisting of MC-001 (SEQ ID NO. 11), MC-002 (SEQ ID NO. 12), MC-003 (SEQ ID NO. 13), MC-004 (SEQ ID NO. 14), MC-005 (SEQ ID NO. 15), MC-006 (SEQ ID NO. 16), MC-007 (SEQ ID NO. 17), MC-008 (SEQ ID NO. 18), MC-009 (SEQ ID NO. 19), MC-010 (SEQ ID NO. 20) or MC-011 (SEQ ID NO. 21). 
     
     
         59 . The combination therapy according to  claim 41  comprising an immunogenic composition comprising a pharmaceutically acceptable excipient or carrier. 
     
     
         60 . The combination therapy according to  claim 41  comprising an immunogenic composition comprising an adjuvant, e.g. ASO1E. 
     
     
         61 . The combination therapy according to  claim 41 , wherein the immunogenic composition is formulated and packaged separately from the one or more therapeutic agents for sequential or simultaneous administration.