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Bivalent hepatitis B vaccine and preparation method thereof

A technology of hepatitis B vaccine and bivalent hepatitis B, which is applied in the field of bivalent hepatitis B vaccine and its preparation, can solve the problems of immune evasion and achieve the effect of preventing infection and good protection effect

Active Publication Date: 2020-09-01
SUZHOU UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The mutation of L21S outside the HBsAg 'a' epitope can also affect the spatial structure and antigenicity of HBsAg, resulting in immune evasion
The latest research confirms that HBV mutant strains containing L21S, I126S and / or G145R have the risk of horizontal transmission in the population after vaccination
At present, there is no vaccine that can effectively induce specific neutralizing antibodies against wild-type HBV and common mutant HBV (containing L21S, I126S and / or G145R mutations)

Method used

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  • Bivalent hepatitis B vaccine and preparation method thereof
  • Bivalent hepatitis B vaccine and preparation method thereof
  • Bivalent hepatitis B vaccine and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0027] A bivalent hepatitis B vaccine, based on its total volume, comprising recombinant wild-type hepatitis B virus surface antigen (recombinant w-HBsAg, concentration of 10 μg / ml), recombinant mutant type hepatitis B virus surface antigen (recombination m-HBsAg, concentration of 10μg / ml) and aluminum hydroxide gel (0.6mg / mL concentration). Recombinant w-HBsAg or recombinant m-HBsAg is a genetically engineered recombinant protein expressed by yeast cells, mammalian cells or other available cells. Wherein, the recombinant w-HBsAg contains 226 amino acid sequences of HBsAg of wild-type HBV, and its amino acid sequence is shown in SEQ ID No.1. The recombinant m-HBsAg contains 226 amino acid sequences of mutant HBsAg at three mutation sites of L21S, I126S and G145R, and its amino acid sequence is shown in SEQ ID No.2.

[0028] Its preparation method is as follows:

[0029] (1) Mix the recombinant w-HBsAg and the recombinant m-HBsAg with the aluminum hydroxide gel solution respe...

Embodiment 2

[0032] A bivalent hepatitis B vaccine, based on its total volume, comprising recombinant wild-type hepatitis B virus surface antigen (recombinant w-HBsAg, concentration of 20 μg / ml), recombinant mutant type hepatitis B virus surface antigen (recombinant m-HBsAg, concentration of 20μg / ml) and aluminum hydroxide gel (1.0mg / mL concentration). Recombinant w-HBsAg or recombinant m-HBsAg is a genetically engineered recombinant protein expressed by yeast cells, mammalian cells or other available cells. Wherein, the recombinant w-HBsAg contains 226 amino acid sequences of HBsAg of wild-type HBV, and its amino acid sequence is shown in SEQ ID No.1. The recombinant m-HBsAg contains 226 amino acid sequences of mutant HBsAg at three mutation sites of L21S, I126S and G145R, and its amino acid sequence is shown in SEQ ID No.2.

[0033] Its preparation method is carried out with reference to embodiment 1.

Embodiment 3

[0035]A bivalent hepatitis B vaccine, based on its total volume, comprising recombinant wild-type hepatitis B virus surface antigen (recombinant w-HBsAg, concentration of 60 μg / ml), recombinant mutant type hepatitis B virus surface antigen (recombinant m-HBsAg, concentration of 60 μg / ml), aluminum hydroxide gel (1.5 mg / mL concentration), and 0.5-0.7 w / v% gelatin. Recombinant w-HBsAg or recombinant m-HBsAg is a genetically engineered recombinant protein expressed by yeast cells, mammalian cells or other available cells. Wherein, the recombinant w-HBsAg contains 226 amino acid sequences of HBsAg of wild-type HBV, and its amino acid sequence is shown in SEQ ID No.1. The recombinant m-HBsAg contains 226 amino acid sequences of mutant HBsAg at three mutation sites of L21S, I126S and G145R, and its amino acid sequence is shown in SEQ ID No.2.

[0036] Its preparation method is as follows:

[0037] (1) Mix the recombinant w-HBsAg and the recombinant m-HBsAg with the aluminum hydrox...

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Abstract

The invention relates to a divalent hepatitis B vaccine. The divalent hepatitis B vaccine comprises, based on the total volume of the vaccine, recombinant wild type hepatitis B surface antigen (recombinant w-HBsAg), recombinant mutant type hepatitis B surface antigen (recombinant m-HBsAg) and an aluminum hydroxide gel solution, wherein the concentration of the recombinant w-HBsAg is 10-60 microgram / ml, the concentration of the recombinant m-HBsAg is 10-60 microgram / ml, the recombinant w-HBsAg contains the HBsAg or HBsAg amino acid fragments of wild type HBV, the recombinant m-HBsAg contains mutant HBsAg or mutant HBsAg amino acid fragments, and the mutant sites of the mutant HBsAg is L21S, I126S and G145R. The invention further provides a preparation method of the divalent hepatitis B vaccine. The preparation method includes: evenly mixing the recombinant w-HBsAg with the aluminum hydroxide gel solution, evenly mixing the recombinant m-HBsAg with the aluminum hydroxide gel solution, and regulating pH to be 5.5-9.6; mixing the two obtained mixtures to obtain the divalent hepatitis B vaccine. The divalent hepatitis B vaccine has the advantages that the divalent hepatitis B vaccine can induce specific neutralizing antibodies aiming at the wild type HBV and common mutant type HBV (containing L21S, I126S and / or G145R mutation) so as to prevent and control the occurrence and prevalence of the hepatitis B, and the preparation method of the divalent hepatitis B vaccine is simple.

Description

technical field [0001] The invention relates to the field of biomedicine, in particular to a bivalent hepatitis B vaccine and a preparation method thereof. Background technique [0002] Chronic infection caused by hepatitis B virus (HBV) is an important public health problem worldwide and the leading cause of liver cirrhosis and hepatocellular carcinoma in my country. According to the report of the World Health Organization, more than 2 billion people in the world have been infected with HBV, and at least 350 million of them have developed into chronic hepatitis B carriers. my country is a big country with hepatitis B epidemic. According to statistics, there are more than 30 million chronic hepatitis B patients in my country, and about 300,000 people die of liver cirrhosis / liver cancer and other related diseases caused by chronic hepatitis B every year. Thus, it is of great significance to prevent, control and eliminate the spread and prevalence of HBV. [0003] Hepatitis ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/295A61K39/29A61P31/20
CPCA61K39/12A61K2039/55505A61K2039/70C12N2730/10134
Inventor 董晨郭志荣刘芳张钧王洁
Owner SUZHOU UNIV
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