POLYPEPTIDE DERIVED FROM gp41, A VACCINE COMPOSITION COMPRISING SAID POLYPEPTIDE, AND USES FOR TREATING AN INFECTION BY AN HIV VIRUS IN AN INDIVIDUAL

Abstract

The present invention relates to the field of the in vitro diagnosis of the progression status of an infection of an individual with a virus belonging to the family of the Human Immunodeficiency Viruses (HIV) as well as with the therapeutical treatment of this infectious disease. The invention also relates to immunological compounds and vaccine compositions comprising a polypeptide derived from gp41.

1 . A method of preventing or treating a disease linked to the infection of an individual with a virus of the HIV family comprising administering an effective amount of
 an antigenic compound consisting of a peptide comprising less than 50 amino acids derived from the gp41 protein of HIV located between the HR1 and HR2 regions of the gp41 protein including the amino acid sequence “SWSNKS”, wherein the peptide is conjugated to a carrier protein or to a synthetic polymer, and   at least one physiologically acceptable excipient,   
       whereby an antibody response directed against the gp41 protein from the said HIV virus is raised and the said antibody response is capable of inducing a counteracting effect on the selective destruction of the CD4 +  T cells by activated NK cells and wherein a disease linked to the infection of an individual with a virus of the HIV family is prevented or treated. 
     
     
         2 . The method of  claim 1 , consisting of a method for treating a disease linked to the infection of an individual with a virus of the HIV family. 
     
     
         3 . The method of  claim 1 , wherein the carrier protein is keyhole limpet hemocyanin (KLH), bovine serum albumin or diphteria toxoid. 
     
     
         4 . The method of  claim 1 , wherein the synthetic polymer is a multiple branch peptide construction comprising a core matrix comprised of lysine residues. 
     
     
         5 . The method of  claim 1 , wherein there is a spacer between the polypeptide and the carrier protein or synthetic polymer. 
     
     
         6 . A method of preventing or treating a disease linked to the infection of an individual with a virus of the HIV family comprising administering an effective amount of:
 an antigenic compound having the formula (III):
   NH 2 -PepNt-[(I) n -PepX n ] n -PepCt-COOH  (III) 
 “PepNt” consists of a polypeptide having an amino acid length varying from 0 to 100 amino acid residues and located at the N-terminal end of the polypeptide of formula (III); 
 “[(I) n -PepX n ]” consists of a polypeptide unit wherein:
 “(I) 1 ” to −“(I) n ” each consists of, one independently from each other, a polypeptide of formula “SWSNKS”, with n being an integer from 1 to 12; and 
 “PepX 1 ” to “PepX n ” each consists of, one independently from the other, a spacer polypeptide having an amino acid length varying from 0 to 30 amino acid residues, with n being an integer from 1 to 12; 
 
 n is the number of [(I) n -PepX n ] polypeptide units in the polypeptide, with n being an integer from 1 to 12; and 
 “PepCt” consists of a polypeptide having an amino acid length varying from 0 to 100 amino acid residues and located at the C-terminal end of the polypeptide of formula (III), 
   and at least one physiologically acceptable excipient,   
       whereby an antibody response directed against the gp41 protein from the said HIV virus is raised and the said antibody response is capable of inducing a counteracting effect on the selective destruction of the CD4 +  T cells by activated NK cells and wherein a disease linked to the infection of an individual with a virus of the HIV family is prevented or treated. 
     
     
         7 . The method of  claim 6 , wherein “PepNt” consists of a polypeptide having an amino acid length varying from 0 to 6 amino acid residues and located at the N-terminal end of the polypeptide of formula (III). 
     
     
         8 . The method of  claim 6 , wherein “[(I) n -PepX n ]” consists of a polypeptide unit wherein:
 “(I) 1 ” to −“(I) n ” each consists of, one independently from each other, a polypeptide of formula “SWSNKS”, with n means 1; and   “PepX 1 ” to “PepX n ” each consists of, one independently from the other, a spacer polypeptide having an amino acid length of 0 amino acid residues, with n being an integer from 1 to 12.   
     
     
         9 . The method of  claim 6 , wherein n is the number of [(I) n -PepX n ] polypeptide units in the polypeptide, with n being an integer of 1. 
     
     
         10 . The method of  claim 6 , wherein “PepCt” consists of a polypeptide having an amino acid length varying from 0 to 5 amino acid residues and located at the C-terminal end of the polypeptide of formula (III). 
     
     
         11 . The method of  claim 6 , wherein the antigenic compound of formula (III) is conjugated to a carrier protein or to a synthetic polymer. 
     
     
         12 . A method of preventing or treating a disease linked to the infection of an individual with a virus of the HIV family comprising administering an effective amount of
 an antigenic compound having the following formula (III):
   NH 2 -PepNt-[(I) n -PepX n ] n -PepCt-COOH  (III), 
 “PepNt” consists of a polypeptide having an amino acid length varying from 0 to 6 amino acid residues and located at the N-terminal end of the polypeptide of formula (III); 
 “[(I) n -PepX n ]” consists of a polypeptide unit wherein:
 “(I) 1 ” to −“(I) n ” each consists of, one independently from each other, a polypeptide of formula “SWSNKS”, with n means 1; and 
 “PepX 1 ” to “PepX n ” each consists of, one independently from the other, a spacer polypeptide having an amino acid length of 0 amino acid residue, with n being an integer from 1 to 12; 
 
 n is the number of [(I) n -PepX n ] polypeptide units in the polypeptide, with n being an integer of 1; and 
 “PepCt” consists of a polypeptide having an amino acid length varying from 0 to 5 amino acid residues and located at the C-terminal end of the polypeptide of formula (III), 
   and at least one physiologically acceptable excipient,   
       whereby an antibody response directed against the gp41 protein from the said HIV virus is raised and the said antibody response is capable of inducing a counteracting effect on the selective destruction of the CD4 +  T cells by activated NK cells and wherein a disease linked to the infection of an individual with a virus of the HIV family is prevented or treated. 
       whereby an antibody response capable of inducing a counteracting effect on the selective destruction of the CD4+ T cells by activated NK cells mediated by the production of antibodies directed against the gp41 protein from the said HIV virus is raised and wherein a disease linked to the infection of an individual with a virus of the HIV family is treated. 
     
     
         13 . The method of  claim 12 , wherein the antigenic compound of formula (III) is conjugated to a carrier protein or to a synthetic polymer. 
     
     
         14 . The method of  claim 13 , wherein the carrier protein is keyhole limpet hemocyanin (KLH), bovine serume albumin or diphteria toxoid. 
     
     
         15 . The method of  claim 13 , wherein the synthetic polymer is a multiple branch peptide construction comprising a core matrix comprised of lysine residues. 
     
     
         16 . The method of  claim 13 , wherein there is a spacer between the polypeptide and the carrier protein or synthetic polymer. 
     
     
         17 . The method of  claim 1 , wherein the composition further comprises an immunoadjuvant compound. 
     
     
         18 . The method of  claim 17 , wherein the immunoadjuvant compound is selected from the group consisting of Freund complete adjuvant, Freund incomplete adjuvant, aluminium hydroxide, calcium phosphate, aluminium phosphate, potassium phosphate, Cholera toxin (CT) and its B subunit (CTB), toxins from  Bordetella pertusssis  (PT), labile toxin (LT) from  Escherichia coli , monophosphoryl lipid A, CpG oligonucleotides, imidazoquinolones, oil in water emulsions comprising squalene and synthetic copolymers, muramyl dipeptides and their derivatives, saponins and immunostimulating complexes (ISCOMs), and dimethyldioctadecylammonium bromide or chloride (DDA). 
     
     
         19 . A method for the in vitro assessment of the progression status of the infection of an individual with an HIV virus, wherein the method comprises the step of detecting in a sample from the individual, antibodies directed against a peptide as defined in any one of  claims 1 ,  6  and  12 . 
     
     
         20 . An antibody directed against the antigenic polypeptide as defined in any one of  claims 1 ,  6  and  12 .