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Vaccine composite adjuvant system and application thereof in antigens

An adjuvant and vaccine technology, applied in the field of immunology, can solve the problem of no strengthening effect of cellular immunity, no strengthening of immune response, etc.

Active Publication Date: 2019-05-03
辽科生物(沈阳)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the aluminum adjuvant has low cost and good safety, this type of adjuvant mainly activates the Th2 immune response, has no strengthening effect on cellular immunity, and has no obvious effect in many human vaccines (especially recombinant protein vaccines and peptide vaccines). The effect of strengthening the immune response

Method used

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  • Vaccine composite adjuvant system and application thereof in antigens
  • Vaccine composite adjuvant system and application thereof in antigens
  • Vaccine composite adjuvant system and application thereof in antigens

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Example 1: Stability experiment of a composite adjuvant system composed of double-stranded polynucleotide-ε-polylysine complex and aluminum adjuvant

[0047] The 21-day-old chicks were randomly divided into eight groups, 10 in each group, and one group was injected with double-stranded polynucleotide-ε-polylysine complex (containing poly IC 2mg, ε-polylysine 1.0 mg, calcium chloride 0.4mmol / L), the second group was injected with a compound adjuvant system composed of double-stranded polynucleotide-ε-polylysine complex and aluminum adjuvant (each ml contains poly IC 2mg, ε- Polylysine 1.0mg, calcium chloride 0.4mmol / L, aluminum hydroxide adjuvant 1.6mg), the third group was injected with double-stranded polynucleotide-ε-polylysine complex and aluminum adjuvant Adjuvant system (each ml contains poly IC 2mg, ε-polylysine 1.0mg, calcium chloride 0.4mmol / L, aluminum phosphate adjuvant 1.0mg), the fourth group was injected with double-stranded polynucleotide—ε-polylysine Com...

Embodiment 2

[0050] Example 2: Detection of abnormal toxicity of the compound adjuvant system composed of double-stranded polynucleotide-ε-polylysine complex and aluminum adjuvant

[0051] The compound adjuvant system composed of double-stranded polynucleotide-ε-polylysine complex and aluminum adjuvant prepared in Example 1 was tested for abnormal toxicity according to the method of "Chinese Pharmacopoeia", and the test results are as follows:

[0052]

[0053] The test results show that the compound adjuvant system composed of the double-stranded polynucleotide-ε-polylysine complex prepared in Example 1 and aluminum adjuvant is qualified for abnormal toxicity test in mice.

Embodiment 3

[0054] Example 3: Potency detection of the compound adjuvant system composed of double-stranded polynucleotide-ε-polylysine complex and aluminum adjuvant combined with inactivated rabies vaccine

[0055] The composite adjuvant system that the double-stranded polynucleotide-ε-polylysine complex prepared in Example 1 and aluminum phosphate adjuvant (aluminum phosphate adjuvant content 1.0mg / ml) is formed and inactivated rabies virus antigen Fully mixed at a ratio of 1:1, as the sample vaccine group, and the inactivated rabies virus antigen as the control vaccine group. Then carry out potency detection by rabies vaccine titer assay method (NIH method), and test result is as follows:

[0056] group

[0057] The test results showed that the potency of the sample vaccine group was higher than that of the control vaccine group.

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Abstract

The present invention provides a vaccine composite adjuvant system and an application thereof in antigens. The vaccine composite adjuvant system is composed of an aluminum adjuvant, a double-strandedpolynucleotide-epsilon-polylysine complex and an aqueous solvent, wherein a clinical use concentration of the aluminum adjuvant is 0.1-10.0 mg / ml, and a clinical use concentration of the epsilon-polylysine complex based on double-stranded polynucleotide is 100-10,000 [mu]g / ml. The constructed compound adjuvant system has good anti-RNase hydrolysis ability, stability, safety and immune stimulatingactivity, is also combined with different forms of vaccines of hepatitis B vaccine, inactivated rabies vaccine, etc., and can also significantly improve immunogenicity of the vaccines.

Description

technical field [0001] The invention relates to the technical field of immunology, in particular to a compound adjuvant system and its application in antigens for immunotherapy and prevention. Background technique [0002] The vaccine adjuvant referred to herein refers to an adjuvant (Adjuvant), also known as an immunomodulator or an immune potentiator (Immunepotentiator), which originated from the Latin word "Adjuvare", which means to assist or enhance. An adjuvant is an additive to a vaccine. When it is injected into the body prior to or mixed with the antigen, it can enhance the body’s immune response to the antigen or change the type of immune response. It is a non-specific immune enhancer, and it has no antigen itself. sex. An ideal adjuvant can not only enhance the immune response, but also enable the body to obtain the best protective immunity. [0003] The purpose of the application of vaccine adjuvants is that, according to research, adjuvants mainly include sever...

Claims

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Application Information

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IPC IPC(8): A61K39/39A61K39/245A61P37/04A61P31/22
Inventor 苏文全
Owner 辽科生物(沈阳)有限公司
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