Vaccines comprising truncated HBC core protein plus saponin-based adjuvants

A saponin and adjuvant technology, applied in the field of vaccines containing truncated HBC core protein and saponin-based adjuvants, can solve problems such as weak immune responses

Inactive Publication Date: 2008-11-19
RAJN BIOTEKH GEZELLSHAFT FJUR NOJE BIOTEKHNOLOGISHE PROTSESSE & PROD MBKH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In animal models (mice), DNA vaccines, especially DNA vaccines based on plasmid vectors encoding hepatitis B virus core antigen (HBcAg), can achieve significant ...

Method used

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  • Vaccines comprising truncated HBC core protein plus saponin-based adjuvants
  • Vaccines comprising truncated HBC core protein plus saponin-based adjuvants
  • Vaccines comprising truncated HBC core protein plus saponin-based adjuvants

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Experimental program
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Effect test

Embodiment 1

[0148] In the first series of experiments, in the product description AbISCO A commercially available saponin complex at -100 (ISCONOVA, Uppsala, Sweden) was used as adjuvant. Core plasmid DNA was used as a positive control, pure PBS, pure adjuvant in PBS, pure HBc in PBS 1-144+I And HBcl-183 in PBS served as a negative control. The composition of the present invention comprises PBS, HBc 1-144+I and AbISCO -100. The amount of each component is shown in Table 1.

[0149] Plasmid pCI / HBV ayw Core basis A., Pudollek H.P., Reifenberg K., Chisari F.V., Schlicht H.J., Reimann J., Schirmbeck R. (1996): DNA Immunization Induces Antibodies and Cytotoxic T Cells to Hepatitis B Core Antigen in H-2b Mice Reaction", J.Immunol.156:3687-95 (the construct is called pCMV-1 / c there), its isolation was carried out according to Carried out according to the manufacturer's instructions.

[0150] For the formulation of the composition of the present invention, HBc 1-144+I First dilute t...

Embodiment 2

[0156] In the following series of experiments, in the product description AbISCO A commercially available saponin complex at -200 (ISCONOVA, Uppsala, Sweden) was used as adjuvant. Core plasmid DNA as positive control; pure PBS, pure adjuvant in PBS, pure HBC in PBS 1-144+I and pure HBc in PBS 1-183 as a negative control. The composition of the present invention comprises PBS, HBc 1-144+I , AbISCO -200 and optionally HBsAg. The amount of each individual component is shown in Table 2.

[0157] For the formulation of the composition of the present invention, HBc 1-144+I And optionally the HBsAg is firstly diluted with PBS to 4 times the final product concentration, and incubated at 37° C. for 30 minutes with shaking. When using HBsAg, first, HBsAg and HBcAg 1-144+I Mix under sterile conditions and dilute likewise with PBS to 4 times the final product concentration. AbISCO -200 (in the form of an aqueous dispersion supplied by the manufacturer) was then added and the ...

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Abstract

The present invention relates to a composition, comprising: i) an HBcAg<1-x>, wherein x is a whole number from the range from 100 to 160, a fragment of this antigen, a variant of this antigen or of the fragment of this antigen or at least two thereof, ii) an adjuvant comprising a saponin or a saponin derivative or a mixture of at least two thereof, and optionally iii) an HBsAg, a fragment from the antigen, a variant of this antigen or of the fragment of this antigen or at least two thereof. The invention also relates to a process for production of a composition, the composition obtainable by this process, a pharmaceutical formulation, the use of the composition or of the pharmaceutical formulation for treatment and/or prevention of HBV infections and HBV-mediated diseases, the use of the composition or of the pharmaceutical formulation for production of a pharmaceutical for treatment and/or for prevention of HBV-infections and HBV-mediated diseases as well as a process for treatment and/or for prevention of HBV-infections and HBV-mediated diseases.

Description

technical field [0001] The present invention relates to a composition, a method for producing the composition, a composition obtainable by the method, a pharmaceutical preparation, the composition or the pharmaceutical preparation in the treatment and / or prevention of hepatitis B virus (HBV) infection and HBV-mediated The use of the composition or the pharmaceutical preparation in the production of medicines for the treatment and / or prevention of HBV infection and HBV-mediated diseases, and the treatment and / or prevention of HBV infection and HBV-mediated diseases method. Background of the invention [0002] According to World Health Organization (WHO) estimates, more than 2 billion people are infected or have been infected with hepatitis B virus (HBV) today. Thus, HBV belongs to the most important human pathogens with enormous impact on human health. [0003] HBV infection can occur via blood, contaminated blood products, and through sexual intercourse, wherein the infect...

Claims

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Application Information

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IPC IPC(8): C07K14/02A61K39/39A61P31/04
CPCA61K2039/55577A61K39/29C12N2730/10122C12N2770/24222C12N2770/24234C07K14/005A61K39/39A61K2039/53A61K2039/57C12N2730/10134A61K39/12A61P1/16A61P31/04A61P31/20A61P37/04C07K14/02
Inventor K·梅尔贝尔P·布基曼Z·亚诺维奇
Owner RAJN BIOTEKH GEZELLSHAFT FJUR NOJE BIOTEKHNOLOGISHE PROTSESSE & PROD MBKH
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