US2008089911A1PendingUtilityA1

Immunological combination compositions and methods

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Assignee: BECKER ROBERT SPriority: Jun 7, 1995Filed: May 18, 2007Published: Apr 17, 2008
Est. expiryJun 7, 2015(expired)· nominal 20-yr term from priority
Inventors:Robert S. BeckerRobert C. HuebnerMaryann GrayKaren BiscardiLorne ErdileBruno Guy
A61P 31/04A61P 31/12A61P 31/00A61P 31/16A61P 37/00Y10S424/828A61K 2039/55544A61K 39/092A61K 39/39C12N 2760/16134A61K 2039/6018A61K 39/0225A61K 2039/55516A61K 2039/55505C07K 14/285A61K 39/12C07K 14/3156A61K 2039/542A61K 39/105C07K 14/20A61K 2039/543A61K 2039/5252A61K 39/145A61K 2039/70Y02A50/30
60
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Claims

Abstract

Immununological compositions and methods for making and using them. The compositions contain at least one antigen and at least one lipoprotein and optionally an adjuvant. The lipoprotein can itself be antigenic or immunogenic. The antigen can be influenza HA and the lipoprotein a recombinantly expressed product having an OspA leader for lipidation and PspA for the protein portion. The antigen can be OspC and the lipoprotein OspA. The components of the composition are co-administered. A potentiated immunological response is obtained by the compositions and methods.

Claims

exact text as granted — not AI-modified
1 . A method for inducing an immunological response in a host comprising the steps of: 
 administering to the host at least one antigen; and    administering to the host a lipoprotein.    
     
     
         2 . The method of  claim 1  wherein the antigen and the lipoprotein are administered simultaneously.  
     
     
         3 . The method of  claim 1  wherein the antigen exhibits epitopes of a bacterial protein.  
     
     
         4 . The method of  claim 3  wherein the antigen is urease.  
     
     
         5 . The method of  claim 3  wherein the antigen is a  Borrelia  antigen other than OspA.  
     
     
         6 . The method of  claim 5  wherein the antigen is OspC.  
     
     
         7 . The method of  claim 1  wherein the lipoprotein, is naturally lipidated.  
     
     
         8 . The method of  claim 1  wherein the lipoprotein is not naturally lipidated.  
     
     
         9 . The method of  claim 1  wherein the lipoprotein is an expression product of a hybrid nucleic acid molecule, comprising a first nucleic acid sequence encoding a signal sequence of a lipoprotein and a second nucleic acid sequence encoding a mature protein, or fragment thereof, which is heterologous to the lipoprotein encoded by the first nucleic acid sequence.  
     
     
         10 . The method of  claim 9  wherein, in the hybrid nucleic acid molecule, the signal sequence is the signal sequence of an OspA protein of a  Borrelia  species, and the sequences are contiguous.  
     
     
         11 . The method of  claim 10  wherein, in the hybrid nucleic acid molecule, the first nucleic acid sequence and the second nucleic acid sequence are coupled in a translational open reading frame relationship.  
     
     
         12 . The method of  claim 11  wherein, in the hybrid nucleic acid molecule, the mature protein is an OspC protein of a  Borrelia  species, or a fragment thereof.  
     
     
         13 . The method of  claim 12  wherein, in the hybrid nucleic acid molecule, the mature protein is an OspC protein from a strain of  Borrelia burgdorferi.    
     
     
         14 . The method of  claim 13  wherein the strain of  Borrelia burgdorferi  is selected from the B31, ACA1 and Ip90 families of strains.  
     
     
         15 . The method of  claim 11  wherein, in the hybrid nucleic acid molecule, the mature protein is PspA or a fragment thereof.  
     
     
         16 . The method of  claim 15  wherein the antigen is an influenza antigen.  
     
     
         17 . The method of  claim 16  wherein the antigen is an HA antigen.  
     
     
         18 . The method of  claim 1  wherein the lipoprotein is antigenic.  
     
     
         19 . The method of  claim 18  wherein the lipoprotein is OspA.  
     
     
         20 . The method of  claim 1  wherein the antigen and lipoprotein are administered mucosally.  
     
     
         21 . The method of  claim 20  wherein the antigen and lipoprotein are administered intranasally.  
     
     
         22 . The method of  claim 20  wherein the antigen and lipoprotein are administered intragastrically.  
     
     
         23 . The method of  claim 20  wherein the antigen and lipoprotein are administered both intranasally and intragastrically.  
     
     
         24 . The method of  claim 1  wherein the immunological response is therapeutic.  
     
     
         25 . The method of  claim 1  wherein the immunological response is prophylactic.  
     
     
         26 . A vaccine or immunogenic composition comprising: 
 an effective amount of at least one antigen; and    an effective amount of at least one lipoprotein.    
     
     
         27 . The composition of  claim 26  wherein the antigen exhibits epitopes of a bacterial protein.  
     
     
         28 . The composition of  claim 27  wherein the antigen is urease.  
     
     
         29 . The composition of  claim 28  wherein the antigen is a  Borrelia  antigen other than OspA.  
     
     
         30 . The composition of  claim 29  wherein the antigen is OspC.  
     
     
         31 . The composition of  claim 26  wherein the lipoprotein is naturally lipidated.  
     
     
         32 . The composition of  claim 26  wherein the lipoprotein is not naturally lipidated.  
     
     
         33 . The composition of  claim 26  wherein the lipoprotein is an expression product of a hybrid nucleic acid molecule, comprising a first nucleic acid sequence encoding a signal sequence of a lipoprotein and a second nucleic acid sequence encoding a mature protein, or fragment thereof, which is heterologous to the lipoprotein encoded by the first nucleic acid sequence.  
     
     
         34 . The composition of  claim 33  wherein, in the hybrid nucleic acid molecule, the signal sequence is the signal sequence of an OspA protein of a  Borrelia  species, and the sequences are contiguous.  
     
     
         35 . The composition of  claim 34  wherein, in the hybrid nucleic acid molecule, the first nucleic acid sequence and the second nucleic acid sequence are coupled in a translational open reading frame relationship.  
     
     
         36 . The composition of  claim 35  wherein, an in the hybrid nucleic acid molecule the mature protein is an OspC protein of a  Borrelia  species, or a fragment thereof.  
     
     
         37 . The composition of  claim 37  wherein, the hybrid nucleic acid molecule, the mature protein is an OspC protein from a strain of  Borrelia burgdorferi.    
     
     
         38 . The composition of  claim 37  wherein the strain of  Borrelia burgdorferi  is selected from the B31, ACA1 and Ip90 families of strains.  
     
     
         39 . The composition of  claim 35  wherein, in the hybrid nucleic acid molecule, the mature protein is PspA or a fragment thereof.  
     
     
         40 . The composition of  claim 39  wherein the antigen is an influenza antigen.  
     
     
         41 . The composition of  claim 40  wherein the antigen is an HA antigen.  
     
     
         42 . The composition of  claim 26  wherein the lipoprotein is antigenic.  
     
     
         43 . The composition of  claim 42  wherein the lipoprotein is an OspA protein of a  Borrelia  species.

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