Processes for treating subjects carrying viral infectious agent

Abstract

This invention provides novel processes for therapeutic applications, including the treatment of subjects carrying infectious agents or having impaired autoimmunity or impaired immune condition. The therapeutic applications disclosed herein are also directed at the treatment of cancerous subjects with malignant tumors containing cancerous cells or malignant or cancerous cells. Vaccination processes for preventing infections in subjects are also provided. The novel processes comprise introducing into or adminstering to a subject one or more antigens, or trained or adopted immune cells. These antigens or immune cells are capable of establishing or increasing at least one first specific immune response and decreasing at least one second specific immune response. Such responses include components, such as cellular immune reaction elements, humoral immune reaction elements and cytokines, the latter also encompassing interferons and lymphokines. Useful compositions are also provided by this invention.

1 - 75 . (canceled) 
   
   
       76 . A process of treating a subject having an immune system and carrying a viral infectious agent, said process comprising the steps of:
 (a) introducing into or administering to said subject one or more antigens, wherein said one or more antigens:
 (1) establish or increase at least one first immune reaction directed against:
 (i) said viral infectious agent; or 
 (ii) cells infected with said viral infectious agent; or 
 (iii) a combination of (1)(i) and (1)(ii) above; and 
 
 (2) decrease at least one second immune reaction which is different from said first immune reaction (a)(1), said second immune reaction being directed toward:
 (i) said viral infectious agent; or 
 (ii) cells infected with said viral infectious agent; or 
 (iii) uninfected cells; or 
 (iv) a combination of any of (2)(i), (2)(ii) and (2)(iii) above, 
 
   wherein said first immune reaction establishes or increases one or more of the following: decrease in viral load by PCR; increase in specific T-cell activity to viral surface antigen as measured by a T-cell proliferation assay (T-cell assay); increase in number of specific T-cell clones secreting IFN γ when exposed to viral surface antigen as measured by an ELISA Spot Assay; increase in IFN γ and/or IL 10 as measured by RT PCR; increase in cytotoxic lymphocyte response; or increase in specific serum cytokines; and   wherein said second immune reaction decreases in one or both enzyme (ALT and/or AST) levels; decrease (improvement) in liver pathology as measured by standard hemotoxylin & eosin (H&E) staining; decrease in viral surface antigen staining by immunohistochemistry; or decrease in viral core antigen staining by immunohistochemistry.   
   
   
       77 . The process according to  claim 76 , wherein said first immune reaction and said second immune reaction comprise cellular responses, humoral responses or cytokine responses, and combinations thereof. 
   
   
       78 . The process according to  claim 77 , wherein said first immune reaction comprises cellular responses and said second immune reaction comprises humoral responses or cytokine responses. 
   
   
       79 . The process according to  claim 76 , wherein said one or more antigens are introduced or administered in multiple doses. 
   
   
       80 . The process according to  claim 76 , wherein said one or more antigens are introduced or administered in different dosages. 
   
   
       81 . The process according to  claim 76 , wherein said one or more antigens comprise different epitopes. 
   
   
       82 . The process according to  claim 76 , wherein said one or more antigens are introduced or administered intermittently or periodically. 
   
   
       83 . The process according to  claim 76 , wherein said one or more antigens are introduced or administered by a single route. 
   
   
       84 . The process according to  claim 76 , wherein said one or more antigens are introduced or administered by a route comprising oral, intravenous, parenteral, transdermal, subcutaneous, intravaginal, intranasal, mucosal, sublingual, aural, intrabronchial, topical, intramuscular, intraperitoneal, or rectal, and combinations of any of the foregoing. 
   
   
       85 . The process according to  claim 76 , wherein said one or more antigens are introduced or administered orally. 
   
   
       86 . The process according to  claim 76 , further comprising introducing or administering one or more carriers. 
   
   
       87 . The process according to  claim 76 , wherein said virus comprises HBV, HCV or HIV. 
   
   
       88 . A process of treating a subject having an immune system and carrying a viral infectious agent, said process comprising the step of:
 (a) introducing into or administering to said subject at least two different antigens, wherein said at least two different antigens:
 (1) establish or increase at least one first immune reaction directed against:
 (i) said viral infectious agent; or 
 (ii) cells infected with said viral infectious agent; or 
 (iii) a combination of (1)(i) and (1)(ii) above; and 
 
 (2) decrease at least one second immune reaction which is different from said first immune reaction (a)(1), said second immune reaction being directed toward:
 (i) said viral infectious agent; or 
 (ii) cells infected with said viral infectious agent; or 
 (iii) uninfected cells; or 
 (iv) a combination of any of (2)(i), (2)(ii) and (2)(iii) above; 
 
   wherein said first immune reaction establishes or increases one or more of the following: decrease in viral load by PCR; increase in specific T-cell activity to viral surface antigen as measured by a T-cell proliferation assay (T-cell assay); increase in number of specific T-cell clones secreting IFN γ when exposed to viral surface antigen as measured by an ELISA Spot Assay; increase in IFN γ and/or IL 10 as measured by RT PCR; increase in cytotoxic lymphocyte response; or increase in specific serum cytokines; and   wherein said second immune reaction decreases in one or both enzyme (ALT and/or AST) levels; decrease (improvement) in liver pathology as measured by standard hemotoxylin & eosin (H&E) staining; decrease in viral surface antigen staining by immunohistochemistry; or decrease in viral core antigen staining by immunohistochemistry.   
   
   
       89 . The process according to  claim 88 , wherein said first immune reaction and said second immune reaction are directed to at least two different epitopes on said at least two different antigens. 
   
   
       90 . The process according to  claim 89 , wherein said first immune reaction is directed to a first epitope or epitopes on said at least two different antigens, and said second immune reaction is directed to a second epitope or epitopes which are different from said first epitope or epitopes, and wherein said first immune reaction and said second immune reaction are mediated by different responses of said subject's immune system. 
   
   
       91 . The process according to  claim 90 , wherein said response or responses of the first immune reaction comprise cellular responses and said response or responses of the second immune reaction comprise humoral responses or cytokine responses. 
   
   
       92 . The process according to  claim 90 , wherein said response or responses of the first immune reaction comprise humoral responses and said response or responses of the second immune reaction comprise cellular responses or cytokine responses. 
   
   
       93 . The process according to  claim 90 , wherein said response or responses of the first immune reaction comprise cytokine responses and said response or responses of the second immune reaction comprises cellular responses or humoral responses. 
   
   
       94 . The process according to  claim 88 , wherein said at least two different antigens are introduced or administered in a single dose or in multiple doses. 
   
   
       95 . The process according to  claim 88 , wherein said at least two different antigens are introduced or administered in different dosages. 
   
   
       96 . The process according to  claim 88 , wherein said at least two different antigens are introduced or administered in a manner comprising continuous administration and intermittent or periodic administration. 
   
   
       97 . The process according to  claim 88 , wherein said at least two different antigens are introduced or administered by a single route or by at least two different routes. 
   
   
       98 . The process according to  claim 88 , wherein said at least two different antigens are introduced or administered by a route comprising oral, intravenous, parenteral, transdermal, subcutaneous, intravaginal, intranasal, mucosal, sublingual, aural, intrabronchial, topical, intramuscular, intraperitoneal, rectal, or combinations of any of the foregoing. 
   
   
       99 . The process according to  claim 88 , wherein said one or more antigens are introduced or administered orally. 
   
   
       100 . The process according to  claim 88 , further comprising introducing or administering one or more carriers. 
   
   
       101 . The process according to  claim 88 , wherein said virus comprises HBV, HCV, HIV and a combination of any of the foregoing.