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Application of C-type CpG in HBV preventive and therapeutic vaccines as adjuvant and preparation method of HBV preventive and therapeutic vaccines

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

Active Publication Date: 2018-03-20
SHANDONG UNIV
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  • 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 in HBV preventive and therapeutic vaccines as adjuvant and preparation method of HBV preventive and therapeutic vaccines
  • Application of C-type CpG in HBV preventive and therapeutic vaccines as adjuvant and preparation method of HBV preventive and therapeutic vaccines
  • Application of C-type CpG in HBV preventive and therapeutic vaccines as adjuvant and preparation method of HBV preventive and therapeutic vaccines

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preparation example Construction

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

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

[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 spp.) produced by Dalian Hanxin. The vaccine of this strain has been used clinically for many years, can stimulate the body to produce immunity against hepatitis B virus,...

Embodiment 1

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

[0080] Raw material and source:

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

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

[0083] CpG M362, Invivogen Company, specification: 1 mg. It was prepared with physiological saline for injection to 1 mg / ml, sterilized by filtration with a 200 μm sterile filter membrane, and frozen at -20°C.

[0084] How the vaccine is prepared:

[0085] Take 100 μl of HBsAg in a sterile Ep tube, add 700 μl of normal saline, and mix well; then take 100 μl of Alhydrogel 2%, drop it into the HBsAg solution, mix it upside down for 5 minutes; finally add 100 μl of CpG M362 solution. The prepared vaccine solution contains 20 μg of hepatitis B surface antigen, Al(OH) per milliliter 3 100 μg, CpG M362 100 μg.

[0086] Immun...

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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 its preparation method. Background technique [0002] HBV infection endangers the health of human beings all over the world. Although the application of HBV preventive vaccine (aluminum adjuvant vaccine) 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 HBV infection, 25%-30% of patients die from liver cirrhosis and liver cancer caused by chronic HBV. [0003] At present, IFN-α and nucleic acid analogues are commonly used clinically to treat chronic HBV. However, the therapeutic effects of IFN-α and nucleic acid analogues have certain limitations. Although IFN-α has an antiviral effect, the clinical treatment rate i...

Claims

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Application Information

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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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