Pharmaceutical composition that includes the surface and nucleocapsid antigens of the hepatitis B virus
This invention reveals the pharmaceutical composition that includes the surface antigen (HBsAg) of the hepatitis B virus (HBV) and the antigen of the nucleocapsid (or core, HBcAg) of the same virus. The HBcAg of this composition contains messenger ribonucleic acid (mRNA) at a proportion of over 45% of the total amount of ribonucleic acid (RNA) in this antigen. Because of the changes in the constitution of the antigens forming it, the composition of the invention is useful for the prevention or treatment of chronic hepatitis B. It also covers the use of this pharmaceutical composition in the production of a drug for immuno-prophylaxis or immunotherapy against HBV infection, and its use to increase the immune response against an additional antigen that is co-administered with the mixture of these antigens.
1. A method for immunoprophylaxis or immunotherapy against infection of hepatitis B virus (HBV), said method comprising administering to an individual in need thereof an effective amount of a pharmaceutical composition comprising i) core antigen of the hepatitis B virus (HBcAg) that includes messenger ribonucleic acid (mRNA) for the HBcAg antigen at a proportion of more than 45% of total ribonucleic acid (RNA) in the HBcAg antigen, and ii) surface antigen (HBsAg) of the hepatitis B virus (HBV), wherein the HBsAg includes phosphatidylserine at a proportion of over 5% of the total amount of phospholipids in the HBsAg.
2. The method of claim 1 wherein the pharmaceutical composition is administered by the parenteral and mucosal routes.
3. The method of claim 1 wherein the individual receiving the immunotherapy is a patient with chronic hepatitis B (CHB).
4. The method of claim 3 wherein the immunotherapy of the CHB patients is used for the prevention of hepatocellular cancer derived from the HBV infection.