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Vaccine composite adjuvant system and applications thereof in antigens

An adjuvant and vaccine technology, applied in the field of immunology, can solve the problems of no strengthening immune response, no strengthening effect of cellular immunity, 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 applications thereof in antigens
  • Vaccine composite adjuvant system and applications thereof in antigens
  • Vaccine composite adjuvant system and applications thereof in antigens

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Example 1: Stability experiment of a composite adjuvant system composed of a double-stranded polynucleotide-ε-polylysine-sulfate polysaccharide complex and aluminum adjuvant

[0050] 21-day-old chickens were randomly divided into eight groups, 10 in each group, and one group was injected with double-stranded polynucleotide-ε-polylysine-sulfated polysaccharide complex (containing 2 mg of poly IC, ε-poly Lysine 1.0mg, heparin sulfate sodium 1.6mg, calcium chloride 0.4mmol / L), the second group was injected with double-stranded polynucleotide-ε-polylysine-sulfate polysaccharide complex and aluminum adjuvant Compound adjuvant system (each ml contains poly IC 2mg, ε-polylysine 1.0mg, heparin sulfate sodium 1.6mg, calcium chloride 0.4mmol / L, aluminum hydroxide adjuvant 1.6mg), the third group injected double-chain Composite adjuvant system composed of polynucleotide-ε-polylysine-polysaccharide sulfate complex and aluminum adjuvant (each ml contains poly IC 2mg, ε-polylysine 1....

Embodiment 2

[0054] Example 2: Detection of abnormal toxicity of the compound adjuvant system composed of double-stranded polynucleotide-ε-polylysine-polysaccharide sulfate complex and aluminum adjuvant

[0055] The composite adjuvant system composed of the double-stranded polynucleotide-ε-polylysine-sulfate polysaccharide 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 :

[0056]

[0057]

[0058] The test results showed that the compound adjuvant system composed of the double-stranded polynucleotide-ε-polylysine-sulfated polysaccharide complex prepared in Example 1 and aluminum adjuvant was qualified for abnormal toxicity test in mice.

Embodiment 3

[0059] Example 3: Potency detection of the compound adjuvant system composed of double-stranded polynucleotide-ε-polylysine-sulfate polysaccharide complex and aluminum adjuvant combined with inactivated rabies vaccine

[0060]The composite adjuvant system composed of the double-stranded polynucleotide-ε-polylysine-polysaccharide sulfate complex prepared in Example 1 and aluminum phosphate adjuvant (aluminum phosphate adjuvant content 1.0 mg / ml) was mixed with sterilized Live rabies virus antigens were fully mixed at a ratio of 1:1 as a sample vaccine group, and inactivated rabies virus antigens as a control vaccine group. Then carry out potency detection by rabies vaccine titer assay method (NIH method), and test result is as follows:

[0061] group

[0062] 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 applications thereof in antigens. The system is composed of an aluminum adjuvant, a double-stranded polynucleotide-epsilon-polylysine-sulfuric acid glycan compound and an aqueous solvent, wherein the clinical use concentration of the aluminum adjuvant is 0.1-10.0 mg / ml, and the clinical use concentration of the double-strandedpolynucleotide-epsilon-polylysine-sulfuric acid glycan compound is 100-10000 [mu]g / ml by double-stranded polynucleotide. The formed compound adjuvant system has good anti-RNase hydrolysis ability, stability, safety and immune stimulating activity, and can significantly improve immunogenicity of vaccine when combined with different forms of vaccines such as hepatitis B vaccine and inactivated rabies vaccine.

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 concept of vaccine adjuvants [0003] Adjuvant (Adjuvant), also known as immunomodulator or immune potentiator (Immunepotentiator), originated from the Latin "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. [0004] Application purpose of vaccine adjuvants [0005] According to research, adjuvants mainly include several modes of action such as immune reg...

Claims

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Application Information

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