Method for treatment of malignant and infectious chronic diseases

Abstract

The present invention relates to methods of treatment useful in chronic diseases, by means of breaking tolerance to self-antigens and increasing autoimmune response against these antigens. More particularly, the present invention relates to methods useful in the treatment of tumors that are growth dependent on the Epidermal Growth Factor. The present invention provides a therapeutic combination that includes the combination of a vaccine against self antigens with a monoclonal antibody against peripheral T cells or a chemotherapeutic drug able to induce a depletion of peripheral T cells. The present invention also provides a method of treatment of chronic diseases in which the rupture of the tolerance to self antigens is essential for the control of the disease, by administering an immune suppressor agent between two cycles of vaccination against a self antigen, for example EGF, for effective treatment for the reduction of tumors whose growth depends on EGF.

1 . A method of treating a subject bearing a malignant or infectious chronic disease comprising the following steps: 
 1.1 immunizing the subject with a vaccine containing a self antigen associated with said malignant or infectious chronic disease, which is coupled to a carrier protein;    1.2 treating said subject with an immune modulator agent; and    1.3 immunizing said subject again with the vaccine of the step 1.1.    
   
   
       2 . The method according to  claim 1  wherein the subject is treated with the vaccine by means of a vaccine cycle to raise titers of measurable serum antibodies until obtaining at least the double of the initial titer measured before beginning the immunizations, preferably three times and even more preferably at least higher than 4 times the initial titer.  
   
   
       3 . A method according to  claim 1  wherein the vaccine containing the self antigen associated with said malignant or infectious chronic disease contains EGF coupled to the carrier protein p64K from  Neisseria meningitidis  and an appropriate adjuvant selected from aluminum hydroxide and Montanide ISA 51.  
   
   
       4 . A method according to  claim 3  wherein the concentration of EGF in said vaccine is in the range between 50 and 250 μg per dose.  
   
   
       5 . A method according to  claim 1  wherein the immuno modulator agent is a monoclonal antibody raised against mammalian T cells.  
   
   
       6 . A method according to  claim 5  wherein the immuno modulator agent is used in a concentration range between 0.5 to 100 mg per doses.  
   
   
       7 . A method according to  claim 6  wherein the immuno modulator agent is an anti-CD25 monoclonal antibody.  
   
   
       8 . A method according to  claim 1  for the treatment of tumors of epidermoid origin.  
   
   
       9 . A method according to  claim 8  for the treatment of lung, breast and head and neck carcinomas.  
   
   
       10 . A method according to  claim 2  wherein the vaccine containing the self antigen associated with said malignant or infectious chronic disease contains EGF coupled to the carrier protein p64K from  Neisseria meningitidis  and an appropriate adjuvant selected from aluminum hydroxide and Montanide ISA 51.  
   
   
       11 . A method according to  claim 10  wherein the concentration of EGF in said vaccine is in the range between 50 and 250 μg per dose.