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Adjuvant used for vaccine and application thereof

An adjuvant and vaccine technology, applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, antibody medical ingredients, etc., can solve potential safety hazards, can not meet the needs of new vaccine development, toxic and side effects and other problems

Active Publication Date: 2016-12-07
PU LIKE BIO ENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there are many types of immune adjuvants studied, such as aluminum gel, oil adjuvant, Freund's adjuvant, microorganisms and their metabolites, nucleic acids and their analogs, cytokines, liposomes, etc. (Dey AK, Srivastava IK.Novel adjuvants and delivery systems for enhancing immune responses induced by immunogens.Expert review of vaccines,2011,10:227-251), but it is difficult to be practically applied due to some inevitable defects such as different degrees of toxic side effects or safety hazards (Mbow ML Batista-Duharte A, Lindblad EB, Oviedo-Orta E. Progress in understanding adjuvant immunotoxicity mechanisms.Toxicology letters,2011,203(2):97-105), these adjuvants are far from meeting the needs of new vaccine development
In particular, a large number of clinical immunization trials believe that aluminum colloidal adjuvant has some problems: (1) it has a strong stimulating effect on Th2-mediated humoral immune response, but has a weak effect on Th1-mediated cellular immune response, only Suitable for vaccines with antibodies as the main protective immunity (Exley C, Siesjo P, Eriksson H. The immunobiology of aluminum adjuvants: how do they really work? Trends in immunology, 2010, 31:103-109); (2) can Promote the production of IgE antibodies, and easily induce allergic reactions in the body; (3) local reactions may form granulomas, and very few local aseptic abscesses may occur; (4) due to their physical and chemical properties, aluminum-containing gel vaccines are afraid of freezing The post-aluminum vaccine is prone to denaturation; (5) it may affect the nervous system of humans and animals (seeing Chinese patents CN102526724A, CN101402666A)
However, in clinical trials, some proteins have poor stability and are easily degraded or denatured under normal conditions, directly affecting the accuracy of test results

Method used

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  • Adjuvant used for vaccine and application thereof
  • Adjuvant used for vaccine and application thereof
  • Adjuvant used for vaccine and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] The preparation of embodiment 1 antigen

[0051] 1.1 Preparation of porcine circovirus antigen

[0052] According to Chinese patent CN103083655A, porcine circovirus type 2 SH strain virus liquid was prepared and the virus liquid content was measured, and the result: the content of porcine circovirus type 2 SH strain was 5×10 6.0 TCID 50 / ml; and inactivate the virus liquid and detect the inactivation effect with the indirect immunofluorescence method IFA, the result: no green PCV2 positive cells are produced, indicating that the porcine circovirus type 2 SH strain virus liquid is successfully inactivated.

[0053] 1.2 Preparation of Mycoplasma hyopneumoniae antigen

[0054] According to the Chinese patent CN103083655A, the bacterial liquid of Mycoplasma hyopneumoniae HN0613 strain was prepared and the content of bacterial liquid was determined, and the result: the content of Mycoplasma hyopneumoniae strain HN0613 was 1×10 9 CCU / ml; and inactivate and test the bacteri...

Embodiment 2

[0057] The preparation of embodiment 2 adjuvants

[0058] Aluminum glue: purchased from General Chemical, LLC of the United States HPA adjuvant.

[0059] Levamisole mother solution: The levamisole raw material purchased from Xi'an Saino Biotechnology Co., Ltd. was heated and dissolved into a 40 mg / ml solution, and sterilized by filtration to obtain a 40 mg / ml levamisole mother solution.

[0060] Sodium polyacrylate mother liquor: mix 1g sodium polyacrylate purchased from Shanghai Yiji Industrial Co., Ltd. with 100% distilled water, heat and boil until completely dissolved, then cool to room temperature, that is, configure a sodium polyacrylate mother liquor with a concentration of 10mg / ml, and Autoclave at 121°C for 30 minutes before use.

Embodiment 3

[0061] Preparation and animal test of embodiment 3 inactivated vaccine composition

[0062] 3.1 Preparation of inactivated vaccine composition

[0063] The antigen prepared in Example 1 and the adjuvant prepared in Example 2 were diluted with PBS solution, and each antigen solution after dilution was mixed with the final concentration of the adjuvant according to the components contained in the inactivated vaccine composition in Table 1, with 500 Stir at -800 rpm for 10-15 minutes, add 1% V / V of thimerosal (purchased from Sinopharm Chemical Reagent Co., Ltd.) solution before terminating the stirring, so that the final concentration does not exceed 1 / 10,000, fully shake Mix well, subpackage, and store at 2-8°C after subpackaging.

[0064]

[0065]

[0066] 3.2 Animal Test of Porcine Circovirus Antigen of Inactivated Vaccine Composition

[0067] Vaccines A1, A2, A3, A6, A7, A9, B1, B2, B3, B6, B7, B9 prepared in Example 3.1 and a reference vaccine control group (PCV2 vac...

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Abstract

The invention provides an adjuvant used for vaccine. The adjuvant comprises alumina gel, levamisole or its derivative, and also polyacrylate. The invention also discloses a vaccine composition containing the adjuvant and an application thereof. The adjuvant can be used as the adjuvant for inactivated vaccine, and also can be used for preparing protein stabilization liquid. The vaccine composition containing the adjuvant can generate humoral immunity for human body and can generate cellular immunity, and can generate good immune response under condition of low antigen content and single immune, and can stabilize protein, degradation and irreversible change cannot be generated.

Description

technical field [0001] The invention belongs to the technical field of veterinary biological products, and specifically relates to an adjuvant for enhancing antigen immune response, the adjuvant includes aluminum gel, levamisole or its derivatives, and polyacrylic acid salt, and is used in vaccine compositions and proteins , without producing toxicity or unwanted side effects in the subject. Background technique [0002] Bacterial, viral and parasitic infections are widespread in humans and animals, and diseases caused by these infectious agents are often resistant to antimicrobial therapy, leaving no effective treatment available. Therefore, more and more people use vaccinology to control infection, specifically through vaccination with live pathogens, inactivated pathogens or their products, or genetically engineered pathogen protein subunits to prepare vaccines to induce infection. specific immunity. However, certain antigens do not produce sufficient stimulation of the...

Claims

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Application Information

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IPC IPC(8): A61K39/39A61K47/22A61P37/04
Inventor 张许科孙进忠王莹田克恭
Owner PU LIKE BIO ENG
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