Pharmaceutical composition comprising a polynucleotide and optionally an antigen especially for vaccination

Abstract

The present invention relates to pharmaceutical compositions comprising at least one fragment of a polynucleotide, preferably at least one antigen, and optionally a pharmaceutically acceptable carrier and/or diluent. In accordance with the present invention was found that the introduction of the pharmaceutical composition into vertebrates will achieve regulation of growth, induction of cellular transcription and translation, protein synthesis, protein expression or protein secretion. The pharmaceutical compositions are useful in vaccination protocols but also in any other therapeutic situation in which immunomodulation is of benefit, such as sub-optimal immune responses, reaction to pathogens, tolerance or autoimmunity.

1 - 23 . (Canceled).  
     
     
         24 . An immunomodulatory composition, comprising 
 (a) an oligonucleotide 5-7 nucleotides long comprising a sequence of a binding site for a transcription factor or a part thereof, and    (b) a pharmaceutically acceptable carrier chosen from liposomes and emulsions.    
     
     
         25 . The composition of  claim 24 , wherein the oligonucleotide is seven nucleotides long.  
     
     
         26 . The composition of  claim 24 , wherein the oligonucleotide is six nucleotides long.  
     
     
         27 . The composition of  claim 24 , wherein the oligonucleotide is five nucleotides long.  
     
     
         28 . The composition of  claim 24 , wherein the oligonucleotide comprises a sequence 5′-Pu-Pu-CpG-Py-Py-3′, wherein Pu means purine and is chosen from adenine (A) and guanine (G) and wherein Py means pyrimidine and is chosen from cytosine (C), thymine (T), and uracil.  
     
     
         29 . The composition of  claim 24 , wherein the oligonucleotide comprises a sequence 5′-Pu-Pu-CpG-Py-C-3′, wherein Pu means purine and is chosen from adenine (A) and guanine (G) and wherein Py means pyrimidine and is chosen from cytosine (C), thymine (T), and uracil.  
     
     
         30 . The composition of  claim 24 , wherein the oligonucleotide comprises a sequence GACGTC.  
     
     
         31 . The composition of  claim 24 , wherein the oligonucleotide comprises at least one phosphorothioate linkage.  
     
     
         32 . The composition of  claim 24 , further comprising an antigen.  
     
     
         33 . The composition of  claim 24 , wherein said composition does not comprise an antigen.  
     
     
         34 . A method of modulating an immune response in a patient, comprising administering to a patient a composition of any one of claims  24 - 32  in a suitable dose to modulate an immune response in the patient.  
     
     
         35 . The method of  claim 34 , wherein the immune response is an immune response of the acquired immune system.  
     
     
         36 . The method of  claim 34 , wherein the immune response is an immune response of the innate immune system.  
     
     
         37 . The method of  claim 34 , wherein the suitable dose to modulate the immune response in the patient shifts an immune response to a Th1-type reactivity.  
     
     
         38 . The method of  claim 34 , wherein the immune response is IgE-mediated allergy.  
     
     
         39 . The method of  claim 34 , wherein the patient is receiving a vaccine.  
     
     
         40 . The method of  claim 39 , wherein the vaccine comprises an antigen chosen from viral, bacterial, parasitic, transplantation, and tumor antigens.  
     
     
         41 . The method of  claim 34 , wherein the patient suffers from cancer.  
     
     
         42 . The method of  claim 34 , wherein the patient suffers from an infection.  
     
     
         43 . A method of treating a patient suffering from an infection, comprising administering to a patient suffering from an infection a suitable dose of a composition of any one of claims  24 - 32  to treat the patient.  
     
     
         44 . The method of  claim 43 , wherein the infection is chosen from Leishmaniasis, Toxoplasmosis, and Mycobacteriosis.