US2005232897A1PendingUtilityA1

Mucosal cytotoxic T lymphocyte responses

56
Assignee: US HEALTHPriority: Sep 11, 1997Filed: Mar 30, 2004Published: Oct 20, 2005
Est. expirySep 11, 2017(expired)· nominal 20-yr term from priority
A61K 39/12A61K 2039/6037C07K 14/005C12N 2740/16134A61K 2039/55522A61K 39/21A61K 2039/55538A61K 2039/541A61K 2039/545C12N 2740/16122A61K 2039/55544Y10S530/826C12N 2710/24143A61K 2039/5256A61K 2039/55566
56
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Claims

Abstract

The invention provides methods for induction of an antigen-specific, mucosal cytotoxic T lymphocyte response useful in preventing and treating infections with pathogens that gain entry via a mucosal surface.

Claims

exact text as granted — not AI-modified
1 . A method for inducing a protective mucosal cytotoxic T lymphocyte (CTL) response in a mammalian subject comprising contacting a mucosal tissue of the subject with a composition comprising a purified soluble antigen.  
     
     
         2 . The method of  claim 1 , wherein the soluble antigen is an antigenic peptide.  
     
     
         3 . The method of  claim 1 , wherein said composition further comprises an adjuvant.  
     
     
         4 . The method of  claim 3 , wherein the adjuvant is selected from cholera toxin (CT), mutant cholera toxin (MCT), or mutant- E. coli  heat labile enterotoxin (MLT).  
     
     
         5 . The method of  claim 1 , further comprising administering a purified cytokine to the subject.  
     
     
         6 . The method of  claim 1 , wherein the cytokine is contacted with a mucosal surface of the subject.  
     
     
         7 . The method of  claim 5 , wherein the purified cytokine is selected from granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), interleukin-7 (IL-7), interleukin-12 (IL-12) or tumor necrosis factor a (TNFa).  
     
     
         8 . The method of  claim 1 , further comprising administering purified interferon-γ to the subject.  
     
     
         9 . The method of  claim 8 , wherein the purified interferon-γ is contacted with a mucosal surface of the subject.  
     
     
         10 . The method of  claim 5 , further comprising administering purified interferon-γ to the subject.  
     
     
         11 . The method of  claim 10 , wherein the purified interferon-γ is contacted with a mucosal surface of the subject.  
     
     
         12 . The method of  claim 1 , wherein said composition further comprises a purified cytokine selected from granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), interleukin-7 (IL-7), interleukin-12 (IL-12) or tumor necrosis factor.  
     
     
         13 . The method of  claim 1 , wherein said composition further comprises purified interferon-γ.  
     
     
         14 . The method of  claim 12 , wherein said composition further comprises purified interferon-γ.  
     
     
         15 . The method of  claim 1 , wherein the antigen is a peptide derived from a pathogenic virus.  
     
     
         16 . The method of  claim 15 , wherein the pathogenic virus is HIV-1.  
     
     
         17 . The method of  claim 15 , wherein the pathogenic virus is influenza virus.  
     
     
         18 . The method of  claim 15 , wherein the pathogenic virus is rotavirus.  
     
     
         19 . The method of  claim 1 , wherein the antigen is a peptide derived from a pathogenic bacterium or protozoan.  
     
     
         20 . The method of  claim 1 , wherein the antigen is a tumor-associated peptide.  
     
     
         21 . The method of  claim 1 , wherein the antigen is a peptide comprising an HIV-1 cluster peptide vaccine construct (CLUVAC) selected from the group consisting of:  
       
         
           
                 
                 
               
                     
                 
                   (SEQ ID NO:1) 
                     
                 
                 
                 
               
                   EQMHEDIISLWDQSLKPCVKRIQRGPGRAFVTIGK, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:2) 
                     
                 
                 
                 
               
                   KQIINMWQEVGKAMYAPPISGQIRRIQRGPGRAFVTIGK, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:3) 
                     
                 
                 
                 
               
                   RDNWRSELYKYKVVKIEPLGVAPTRIQRGPGRAFVTIGK, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:4) 
                     
                 
                 
                 
               
                   AVAEGTDRVIEVVQGAYRAIRHIPRRIRQGLERRIQRGPGRAFVTIGK, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:5) 
                     
                 
                 
                 
               
                   DRVIEVVQGAYRAIRHIPRRIRQGLERRIQRGPGRAFVTIGK, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:6) 
                     
                 
                 
                 
               
                   DRVIEVVQGAYRAIRRIQRGPGRAFVTIGK, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:7) 
                     
                 
                 
                 
               
                   AQGAYRAIRHIPRRIRRIQRGPGRAFVTIGK, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:8) 
                     
                 
                 
                 
               
                   EQMHEDIISLWDQSLKPCVKRIHIGPGRAFYTTKN, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:9) 
                     
                 
                 
                 
               
                   KQIINMWQEVGKAMYAPPISGQIRRIHIGPGRAFYTTKN, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:10) 
                     
                 
                 
                 
               
                   RDNWRSELYKYKVVKIEPLGVAPTRIHIGPGRAFYTTKN, 
                     
                 
                     
                 
                 
                 
               
                   SEQ ID NO:11) 
                     
                 
                 
                 
               
                   AVAEGTDRVIEVVQGAYRAIRHIPRRIRQGLERRIHIGPGRAFYTTKN, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:12) 
                     
                 
                 
                 
               
                   DRVIEVVQGAYRAIRHIPRRIRQGLERRIHIGPGRAFYTTKN, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:13) 
                     
                 
                 
                 
               
                   DRVIEVVQGAYRAIRRIHIGPGRAFYTTKN 
                     
                 
                   and 
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:14) 
                     
                 
                 
                 
               
                   AQGAYRAIRHIPRRIRRIHIGPGRAFYTTKN. 
                     
                 
                     
                 
             
                
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
                
               
            
             
                
               
            
             
                
                
               
            
           
         
       
     
     
         22 . (canceled)  
     
     
         23 . The method of  claim 21 , wherein the HIV-1 CLUVAC is HIV-1 CLUVAC PCLUS3-18MN (SEQ ID NO:9).  
     
     
         24 . The method of  claim 21 , wherein the HIV-1 CLUVAC is HIV-1 CLUVAC PCLUS 6.1-18MN (SEQ ID NO:12).  
     
     
         25 . A method for inducing a protective mucosal CTL response in a subject, comprising contacting a mucosal tissue of the subject with a composition comprising a soluble antigen, wherein said composition does not comprise an adjuvant.  
     
     
         26 . The method of  claim 25 , further comprising administering a purified cytokine to the subject.  
     
     
         27 . The method of  claim 25 , wherein the cytokine is contacted with a mucosal surface of the subject.  
     
     
         28 . The method of  claim 27 , wherein the purified cytokine is selected from granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), interleukin-7 (IL-7), interleukin-12 (IL-12) or tumor necrosis factor a (TNFa).  
     
     
         29 . The method of  claim 25 , further comprising administering purified interferon-γ to the subject.  
     
     
         30 . The method of  claim 29 , wherein the purified interferon-γ is contacted with a mucosal surface of the subject.  
     
     
         31 . The method of  claim 26 , further comprising administering purified interferon-γ to the subject.  
     
     
         32 . The method of  claim 31 , wherein the purified interferon-γ is contacted with a mucosal surface of the subject.  
     
     
         33 . The method of  claim 25 , wherein said composition further comprises a purified cytokine selected from granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), interleukin-7 (IL-7), interleukin-12 (IL-12) or tumor necrosis factor.  
     
     
         34 . The method of  claim 25 , wherein said composition further comprises purified interferon-γ.  
     
     
         35 . The method of  claim 33 , wherein said composition further comprises purified interferon-γ.  
     
     
         36 . The method of  claim 25 , wherein the antigen is a peptide derived from a pathogenic virus.  
     
     
         37 . The method of  claim 36 , wherein the pathogenic virus is HIV-1.  
     
     
         38 . The method of  claim 36 , wherein the pathogenic virus is influenza virus.  
     
     
         39 . The method of  claim 36 , wherein the pathogenic virus is rotavirus.  
     
     
         40 . The method of  claim 25 , wherein the antigen is a peptide derived from a pathogenic bacterium or protozoan.  
     
     
         41 . The method of  claim 25 , wherein the antigen is a tumor-associated peptide.  
     
     
         42 . The method of  claim 25 , wherein the antigen is a peptide comprising an HIV-1 cluster peptide vaccine construct (CLUVAC) selected from the group consisting of:  
       
         
           
                 
                 
               
                     
                 
                   (SEQ ID NO:1) 
                     
                 
                 
                 
               
                   EQMHEDIISLWDQSLKPCVKRIQRGPGRAFVTIGK, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:2) 
                     
                 
                 
                 
               
                   KQIINMWQEVGKAMYAPPISGQIRRIQRGPGRAFVTIGK, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:3) 
                     
                 
                 
                 
               
                   RDNWRSELYKYKVVKIEPLGVAPTRIQRGPGRAFVTIGK, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:4) 
                     
                 
                 
                 
               
                   AVAEGTDRVIEVVQGAYRAIRHIPRRIRQGLERRIQRGPGRAFVTIGK, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:5) 
                     
                 
                 
               
                   DRVIEVVQGAYRAIRHIPRRIRQGLERRIQRGPGRAFVTIGK, 
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:6) 
                     
                 
                 
                 
               
                   DRVIEVVQGAYRAIRRIQRGPGRAFVTIGK, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:7) 
                     
                 
                 
                 
               
                   AQGAYRAIRHIPRRIRRIQRGPGRAFVTIGK, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:8) 
                     
                 
                 
                 
               
                   EQMHEDIISLWDQSLKPCVKRIHIGPGRAFYTTKN, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:9) 
                     
                 
                 
                 
               
                   KQIINMWQEVGKAMYAPPISGQIRRIHIGPGRAFYTTKN, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:10) 
                     
                 
                 
                 
               
                   RDNWRSELYKYKVVKIEPLGVAPTRIHIGPGRAFYTTKN, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:11) 
                     
                 
                 
                 
               
                   AVAEGTDRVIEVVQGAYRAIRHIPRRIRQGLERRIHIGPGRAFYTTKN, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:12) 
                     
                 
                 
                 
               
                   DRVIEVVQGAYRAIRHIPRRIRQGLERRIHIGPGRAFYTTKN, 
                     
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:13) 
                     
                 
                 
                 
               
                   DRVIEVVQGAYRAIRRIHIGPGRAFYTTKN 
                     
                 
                   and 
                 
                     
                 
                 
                 
               
                   (SEQ ID NO:14) 
                     
                 
                 
                 
               
                   AQGAYRAIRHIPRRIRRIHIGPGRAFYTTKN. 
                     
                 
                     
                 
             
                
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
                
               
            
             
                
               
            
             
                
                
               
            
           
         
       
     
     
         43 . (canceled)  
     
     
         44 . The method of  claim 42 , wherein the HIV-1 CLUVAC is HIV-1 CLUVAC PCLUS3-18MN (SEQ ID NO:9).  
     
     
         45 . The method of  claim 42 , wherein the HIV-1 CLUVAC is HIV-1 CLUVAC PCLUS 6.1-18MN (SEQ ID NO:12).  
     
     
         46 . An immunogenic composition for inducing a protective mucosal CTL response in a subject and adapted for intrarectal administration comprising a purified soluble antigen formulated for intrarectal delivery to the rectum, colon, sigmoid colon, or distal colon.  
     
     
         47 . The immunogenic composition of  claim 46 , which comprises a rectal enema, foam, suppository, or topical gel.  
     
     
         48 . The immunogenic composition of  claim 46 , further comprising a base, carrier, or absorption-promoting agent adapted for intrarectal delivery.  
     
     
         49 . The immunogenic composition of  claim 48 , which includes a rectal emulsion or gel preparation.  
     
     
         50 . The immunogenic composition of  claim 48 , wherein the soluble antigen is admixed with a homogenous gel carrier.  
     
     
         51 . The immunogenic composition of  claim 48 , wherein the homogenous gel carrier is a polyoxyethylene gel.  
     
     
         52 . The immunogenic composition of  claim 48 , wherein the soluble antigen is admixed with a rectally-compatible foam.  
     
     
         53 . The immunogenic composition of  claim 48 , wherein the soluble antigen is formulated in a suppository.  
     
     
         54 . The immunogenic composition of  claim 53 , wherein the suppository is comprised of a base selected from a polyethyleneglycol, witepsol H15, witepsol W35, witepsol E85, propyleneglycol dicaprylate (Sefsol 228), Miglyol810, hydroxypropylcellulose-H (HPC), or carbopol-934P (CP).  
     
     
         55 . The immunogenic composition of  claim 53 , comprising at least two base materials.  
     
     
         56 . The immunogenic composition of  claim 46 , including a stabilizing agent to minimize intrarectal degradation of the soluble antigen.  
     
     
         57 . The immunogenic composition of  claim 46 , including an absorption-promoting agent.  
     
     
         58 . The immunogenic composition of  claim 57 , wherein the absorption-promoting agent is selected from a surfactant, mixed micelle, enamines, nitric oxide donor, sodium salicylate, glycerol ester of acetoacetic acid, clyclodextrin or beta-cyclodextrin derivative, or medium-chain fatty acid.  
     
     
         59 . The immunogenic composition of  claim 46 , further comprising an adjuvant.  
     
     
         60 . The immunogenic composition of  claim 59 , wherein the adjuvant is selected from cholera toxin (CT), mutant cholera toxin (MCT), mutant- E. coli  heat labile enterotoxin, o(Original) r pertussis toxin.  
     
     
         61 . The immunogenic composition of  claim 59 , wherein the adjuvant is conjugated to a mucosal tissue or T cell binding agent.  
     
     
         62 . The immunogenic composition of  claim 61 , wherein the mucosal tissue or T cell binding agent is selected from protein A, an antibody that binds a mucosal tissue- or T-cell-specific protein, or a ligand or peptide that binds a mucosal tissue- or T-cell-specific protein.  
     
     
         63 . The immunogenic composition of  claim 59 , wherein the adjuvant comprises a recombinant cholera toxin (CT) having a B chain of CT substituted by protein A conjugated to a CT A chain to eliminate toxicity and enhance mucosal tissue binding mediated by protein A.  
     
     
         64 . The immunogenic composition of  claim 59 , wherein the adjuvant is conjugated to a protein or peptide that binds specifically to T cells.  
     
     
         65 . The immunogenic composition of  claim 64 , wherein the protein or peptide binds to CD4 or CD8.  
     
     
         66 . The immunogenic composition of  claim 66 , wherein the protein or peptide is an HIV V3 loop or T cell-binding peptide fragment thereof.  
     
     
         67 . The immunogenic composition of  claim 59 , further comprising purified IL-12.  
     
     
         68 . The immunogenic composition of  claim 59 , further comprising purified interferon-γ.  
     
     
         69 . The immunogenic composition of  claim 68 , further comprising purified IL-12.

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