Pharmaceutical compositions comprising inactivated HIV viral particles and non-pathogenic lactobacilli for the induction of antigen-specific immunotolerance
The present invention relates to pharmaceutical compositions comprising a mixture of a specific HIV antigen and a non-pathogenic living bacterium. Said specific HIV antigen comprises one or more epitopes from Gag and/or Pol proteins and is preferably under a particulate form. Said bacterium is preferably Lactobacillus plantarum . These compositions are useful for preventing and/or treating an HIV disease in humans.
1. An oral pharmaceutical composition comprising a mixture of inactivated HIV virus particles and non-pathogenic Lactobacillus bacteria, in amounts effective for inducing antigen-specific immunotolerance.
2. A method for inducing antigen-specific immunotolerance, comprising administering to a human in need thereof a pharmaceutically effective amount of a pharmaceutical composition according to claim 1 .
3. A pharmaceutical kit for preventing and/or treating an HIV disease in a human in need thereof, comprising:
in a first container, inactivated HIV virus particles; and
in a second container, non-pathogenic Lactobacillus bacteria,
said antigen and said Lactobacillus bacteria each being in a pharmaceutically acceptable carrier for oral administration, and being present in amounts effective for inducing antigen-specific immunotolerance.
4. The pharmaceutical composition according to claim 1 , wherein said HIV is HIV-1 or HIV-2.
5. The pharmaceutical composition according to claim 1 , wherein said bacteria are Lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus casei, Lactobacillus paracasei, Lactobacillus johnsonii, Lactobacillus plantarum, Lactobacillus reuteri, Lactobacillus rhamnosus, Lactobacillus brevis, Lactobacillus gasseri , or Lactobacillus salivarius.
6. The pharmaceutical composition according claim 1 , wherein:
the amount of inactivated HIV virus particles in the pharmaceutical composition is from about 10 6 to about 10 12 per ml of said mixture; and/or
the amount of said non-pathogenic bacteria bacterium in the pharmaceutical composition is from about 10 4 to about 10 14 CFU per ml of said mixture.
7. The pharmaceutical composition according to claim 1 , wherein the ratio in said mixture of said virus particles to said bacterium is from about 1:10 to about 1:1000.
8. The pharmaceutical composition according to claim 1 , wherein the ratio in said mixture of said virus particles to said bacterium is about 1:100.
9. The method according to claim 2 , wherein said HIV disease is AIDS or seroconversion.
10. The method according to claim 2 , wherein said composition is administered once or several times consecutively.
11. The method according to claim 2 , wherein:
a dose of about 10 8 to 10 14 inactivated HIV virus particles is administered per day to said human; and/or
a dose of about 10 6 to about 10 16 CFU of said non-pathogenic bacteria is administered per day to said human.