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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 CTL responses, but all current vaccines so far have only shown very limited responses in humans. Weak immune response and does not stimulate any effective CTL response

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

Examples

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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