Application of C-type cpg as adjuvant in HBV preventive and therapeutic vaccine and preparation method thereof

A therapeutic vaccine and preventive technology, applied in the fields of biotechnology and genetic engineering vaccines, can solve the problem of weak activation of IL-12 cytokines in the NF-κB signaling pathway, and achieve the effect of facilitating development and convenient preparation

Active Publication Date: 2021-01-01
SHANDONG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Type A CpGs, such as ODN 1585, ODN2216, and ODN2336, mainly activate pDC and promote the secretion of IFN; type B CpGs, such as ODN1826, ODN 7909, and ODN 2006, mainly activate the NF-κB signaling pathway and promote the generation of Th1 responses; C Compared with type B CpG ODNs, type C CpG, such as ODN 2395 and ODN M362, has weaker ability to activate NF-κB signaling pathway and produce IL-12 cytokines. Can it be used as a candidate for HBV preventive and therapeutic vaccines? Adjuvants have no related reports

Method used

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  • Application of C-type cpg as adjuvant in HBV preventive and therapeutic vaccine and preparation method thereof
  • Application of C-type cpg as adjuvant in HBV preventive and therapeutic vaccine and preparation method thereof
  • Application of C-type cpg as adjuvant in HBV preventive and therapeutic vaccine and preparation method thereof

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preparation example Construction

[0059]In a preferred embodiment of the present invention, the method for preparing the above-mentioned HBV preventive vaccine includes: adding aluminum hydroxide dropwise to the HBsAg solution, mixing upside down, and then adding the CpG M362 solution to obtain the HBV preventive vaccine. Vaccine, this vaccine solution can be made into a unit-dose vaccine preparation for injection after being subpackaged.

[0060]In a preferred embodiment of the present invention, the present invention also provides an application of type C CpG M362 as an adjuvant in a therapeutic vaccine for HBV.

[0061]In a preferred embodiment of the present invention, the active ingredients of the HBV therapeutic vaccine include rHBV vaccine and CpG M362.

[0062]Among them, the rHBV vaccine is a recombinant hepatitis B vaccine (Hansenula yeast) produced by Dalian Hanxin. This strain of vaccine has been used clinically for many years, can stimulate the body to produce immunity against hepatitis B virus, and can effectiv...

Embodiment 1

[0079]The preparation method of the preventive hepatitis B vaccine of the present invention:

[0080]Raw materials and sources:

[0081]HBsAg is a product derived from Hansenula yeast produced by Dalian Hanxin Biological Products Co., Ltd., with a concentration of 200μg / ml.

[0082]Alhydrogelinvivogen company, specification: 250ml, Al(OH)3Concentration: 9-10mg / ml

[0083]CpG M362, invivogen company, specification: 1mg. Prepare 1mg / ml with normal saline for injection, filter and sterilize with 200μm sterile filter membrane, and store frozen at -20°C.

[0084]Preparation method of vaccine:

[0085]Take 100μl of HBsAg in a sterile Ep tube, add 700μl of saline, and mix well; then take 100μl of Alhydrogel2%, drop it into the HBsAg solution, mix upside down for 5min; finally add 100μl of CpG M362 solution. The prepared vaccine solution contains 20μg of hepatitis B surface antigen, Al(OH) per ml3100μg, CpG M362 100μg.

[0086]Immunization strategies for preventive hepatitis B vaccine:

[0087]The experimental gro...

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Abstract

The invention discloses application of C-type CpG M362 in HBV preventive and therapeutic vaccines as an adjuvant and a preparation method of the HBV preventive and therapeutic vaccines. Compared withthe traditional HBV preventive vaccines, the HBV preventive vaccines taking the CpG M362 as the adjuvant have the maximum advantages that an organism can be induced to generate high-level body fluid response, and the cell response of the organism can be enhanced. Meanwhile, by applying the HBV therapeutic vaccines taking the CpG M362 as the adjuvant into clinical HBV treatment, a hepatic immunosuppression microenvironment caused by chronic HBV infection can be improved, immune tolerance caused by the HBV infection can be reversed, the cell response and body fluid response of the organism can be enhanced, and thus, HBV is completely cleared out. More importantly, after immunization of the vaccines taking the CpG M362 as the adjuvant, the organism can be induced to form long-term immunological memory, the organism can be protected from HBV reinfection, and a novel effective policy is provided for the clinical prevention of the HBV and the treatment of chronic HBV.

Description

Technical field[0001]The invention belongs to the field of biotechnology and genetic engineering vaccines, and specifically relates to the application of C-type CpG M362 as an adjuvant in HBV preventive and therapeutic vaccines and a preparation method thereof.Background technique[0002]HBV infection endangers human health worldwide. Although the application of HBV preventive vaccines (aluminum adjuvant vaccines) has been quite common, 5%-10% of the population still cannot produce effective anti-HBV antibodies (anti-HBs), resulting in approximately 3.5 million people suffering from chronic diseases each year. HBV infection, 25%-30% of patients die from liver cirrhosis and liver cancer caused by chronic HBV.[0003]At present, two drugs, IFN-α and nucleic acid analogs, are commonly used clinically to treat chronic HBV. However, the therapeutic effects of IFN-α and nucleic acid analogs have certain limitations. Although IFN-α has antiviral effects, the clinical treatment rate is only 20-...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/39A61K39/29A61P31/20
CPCA61K39/12A61K39/39A61K2039/55505A61K2039/55561C12N2730/10134A61K2300/00
Inventor 张建赵华俊王冠韩秋菊
Owner SHANDONG UNIV
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