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Desorption composition of adsorbed vaccine containing cpg ODN and its application

A desorption and adsorption type technology, applied in the field of determination of the efficacy of adjuvanted vaccines, can solve the problems of no reported CpGODN composite adjuvant adsorption adsorption type vaccine desorption method, time-consuming, vaccine inapplicability, etc. The effect of immune activity, easy promotion and application, and rapid separation

Active Publication Date: 2022-08-05
BEIJING BIOLOGICAL PROD INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this desorption method is suitable for hepatitis B vaccine adsorbed by aluminum hydroxide adjuvant, but not for CpG ODN complex adjuvant adsorbed vaccine
and this method takes a long time
[0010] No desorption method for CpG ODN complex adjuvant-adsorbed vaccine has been reported so far

Method used

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  • Desorption composition of adsorbed vaccine containing cpg ODN and its application
  • Desorption composition of adsorbed vaccine containing cpg ODN and its application
  • Desorption composition of adsorbed vaccine containing cpg ODN and its application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] This implementation provides a method for detecting antigen efficacy in a CpG ODN composite adjuvant adsorption vaccine, the specific steps are as follows:

[0064] Step 1: Preparation of desorption reagents: wherein the final molar concentration of potassium phosphate is 0.6M, the final molar concentration of magnesium chloride is 0.1M, the final volume concentration of Triton-100 is 1%, and the final volume concentration of M199 medium is 20% ;

[0065] Step 2: Desorb the CpG ODN composite adjuvant-adsorbed vaccine reference substance and the sample to be tested: Mix the reference substance and sample with the desorption reagent in a volume ratio of 1:1, incubate at 28°C for 60 minutes, and incubate every 20 minutes during the incubation process. Invert and mix once;

[0066] The obtained mixture was centrifuged, the centrifugation program was 6000rpm, the centrifugation time was 20min, and the centrifugation temperature was 4°C to obtain a supernatant;

[0067] Ste...

Embodiment 2

[0075] This implementation provides the results of antigen dissociation in different batches of CpG ODN composite adjuvant-adsorbed novel coronavirus inactivated vaccines, and examines the applicability of the dissociation method to different batches of samples.

[0076] The specific desorption and antigen potency determination methods are the same as those in Example 1.

[0077] Table 4 shows the test results of antigen potency in different batches of CpG ODN composite adjuvant-adsorbed novel coronavirus inactivated vaccines.

[0078] Table 4

[0079]

[0080] Sample 1-5 double parallel lines result as figure 2 shown.

[0081] As can be seen from Table 4, the present invention has good applicability to the CpG ODN composite adjuvant adsorption type novel coronavirus inactivated vaccine.

Embodiment 3

[0083] This example verifies the applicability of desorption of CpG ODN composite adjuvant-adsorbed new inactivated vaccines using desorption compositions with different component ratios, different desorption conditions, and different centrifugation parameters.

[0084] The theoretical antigen concentration of the sample to be detected used in this example is 13U / ml, and the sample dilution scheme is 2X, 4X, 8X, and 16X. Antigen potency test results between 0.5-2.0 are considered qualified.

[0085] Table 5 shows the desorption conditions used in each sample group and the detection results of antigen potency.

[0086] The specific antigen potency determination operation procedure is the same as that in Example 1.

[0087] table 5

[0088]

[0089] Samples 1-6 double parallel line results such as image 3 shown.

[0090] It can be seen from Table 5 that the test results are all qualified, and it is verified that the desorption composition, the desorption reagent and the ...

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PUM

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Abstract

The present invention provides a desorption composition for an adsorption-type vaccine containing CpG ODN, wherein the desorption composition comprises potassium phosphate, M199 medium, magnesium chloride, and Triton-100. In another aspect, the present invention provides a kit for an adsorption-type vaccine containing CpG ODN adjuvant, comprising the above-mentioned desorption composition. In another aspect, the present invention provides an in vitro method for testing the efficacy of an adsorbed vaccine containing CpG ODN adjuvant. On the other hand, the present invention provides the application of the composition, kit and detection method in the desorption and in vitro efficacy detection of the adsorption vaccine containing CpG ODN adjuvant. The desorption composition provided by the invention fills the gap in the dissociation of the adsorption vaccine antigen containing CpG ODN adjuvant, provides a fast and accurate method for measuring the efficacy of the adsorption vaccine containing CpG ODN adjuvant, and has pioneering significance.

Description

technical field [0001] The present invention relates to the determination of the efficacy of an adjuvant-containing vaccine, in particular to a desorption composition in an adsorption-type vaccine containing CpG ODN and a method for determining the efficacy of an antigen in an adsorption-type vaccine containing CpG ODN. Background technique [0002] Adjuvant is an important component of many human vaccines. The addition of adjuvant to vaccines can enhance the body's immune response to antigens. Aluminum adjuvant is the earliest and most widely used vaccine adjuvant. The adsorption of aluminum adjuvant to antigen is affected by its own physical and chemical properties, the ionic strength of the solution and the concentration of the antigen. to enhance the immune response. [0003] CpG ODN (CpG oligonucleotide) is a representative of new adjuvants, which can bind to Toll-like receptors on the cell membrane and induce the production of various cytokines. After binding to TLR...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/569G01N33/58G01N33/543G01N33/53
CPCG01N33/56983G01N33/581G01N33/54306G01N33/5306G01N2333/165G01N2469/10Y02A50/30
Inventor 杨晓明王辉赵玉秀梁宏阳郑晓彤闫君宇杨兆娜于守智李为栋杨蓉
Owner BEIJING BIOLOGICAL PROD INST CO LTD
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