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Meningococcus vaccine

A meningococcal and vaccine technology, which is applied to antibacterial drugs, medical preparations with inactive ingredients, carrier-binding antigen/hapten components, etc. The effect of reducing the cost of vaccines and improving the immune effect

Inactive Publication Date: 2009-10-21
NAT VACCINE & SERUM INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, none of these documents involve chemical conjugates of meningococcal capsular polysaccharides and carrier proteins alone with oligodeoxynucleotides (the oligodeoxynucleotides) containing at least one unmethylated CpG dinucleotide. The combined effect of the first adjuvant with a length of 15-35 nucleotides)

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1. CpG-ODN can enhance the immune response of mice to the chemical conjugates of group A meningococcal capsular polysaccharide and tetanus toxoid

[0037] According to the method described in the patent document CN101007167A (referring to specification page 9~12 page embodiment 1 and embodiment 4), the chemistry of preparation A group meningococcal capsular polysaccharide and group A meningococcal capsular polysaccharide and tetanus toxoid Conjugates (hereinafter abbreviated as "Ag"). In the chemical conjugate, the polysaccharide content is 106 μg / ml, and the carrier protein content is 269 μg / ml.

[0038] The CpG-ODN used in this example was designed by the inventors, and its sequence is as follows: 5′-TCGTTCGTTCGTTCGTTCGTT-3′, which was artificially synthesized by Shanghai Sangon Biotechnology Co., Ltd., and subjected to full-chain thio modification, and polyacrylamide gel electrophoresis (PAGE) purified, dissolved in normal saline, and stored in a -20°C refri...

Embodiment 2

[0046] Example 2. CpG-ODN can enhance the persistence of immune response in mice to chemical conjugates of meningococcal group A capsular polysaccharide and tetanus toxoid

[0047] Balb / c mice were immunized according to the same method as in Example 1, and then the specific IgG antibody titer of meningococcal capsular polysaccharide was detected to evaluate the effect of CpG-ODN on group A meningococcal capsular polysaccharide in mice The impact of the chemical conjugates of tetanus toxoid and tetanus toxoid on the persistence of immune response, the difference is that the 4th week and 39th week after the initial immunization were boosted once in the same way, and the 4th week and 6th week after the initial immunization Blood was collected at week 10, week 10, week 14, week 21, week 39, and week 41, and serum was separated, and the method described in Example 1 was used to detect the total antibody specific to meningococcal polysaccharide IgG. see results figure 2 .

[004...

Embodiment 3

[0049] Example 3. CpG-ODN can reduce the amount of chemical conjugates of group A meningococcal capsular polysaccharide and tetanus toxoid

[0050] Balb / c mice are immunized according to the same method as in Example 1, and then detect the meningococcal capsular polysaccharide specific IgG antibody titer, to measure CpG-ODN to A group meningococcal capsular polysaccharide and tetanus The influence of the dosage of the chemical conjugate of toxin, the difference is that the dosage of the chemical conjugate of meningococcal capsular polysaccharide and tetanus toxoid is different, and its consumption is original times dose respectively (2.2 μ g of Ag / mouse ), one quarter dose (0.55 μg of Ag / mouse) and one sixteenth dose (0.14 μg of Ag / mouse). see results Figure 3a and Figure 3b .

[0051] Figure 3a and Figure 3b The results shown are the polysaccharide-specific IgG antibody titers at the 4th week after the primary immunization and at the 2nd week after the booster immuni...

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Abstract

The invention relates to a meningococcus vaccine comprising a chemical conjugate of meningococcus capsular polysaccharide and carrier protein, and a first adjuvant, wherein the first adjuvant is oligodeoxynucleotide comprising at least one non-methylation CpG dinucleotide, and the length of the oligodeoxynucleotide is 15-35 ribonucleotides. The adjuvant used for increasing the immunization effect of the meningococcus vaccine is a novel human vaccine adjuvant with favorable potential application prospect, and the chemical essence of the adjuvant is the oligodeoxynucleotide which is synthesized manually and contains the CpG dinucleotide. By a receptor TLR9 activated immune system on immune cells, the adjuvant reinforces specific immune response aiming at vaccine antigens. The immunization effect of a vaccine can be increased by adding the vaccine adjuvant into the vaccine, so that the dosage of the vaccine antigen can be reduced, the immunization injection times can be reduced and the vaccine cost can be reduced.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a meningococcal vaccine. Background technique [0002] Epidemic meningitis (referred to as "meningococcus") is caused by meningococcus and is one of the main acute respiratory infectious diseases in humans. According to the chemical structure of capsular polysaccharides, meningococci can be divided into more than a dozen serogroups, among which A, B, C, Y and W135 are the most prevalent bacterial groups. Vaccination is the main way to prevent ECM. The vaccine prepared with meningococcal capsular polysaccharide has a certain preventive effect, but it is a T cell-independent antigen, which has a poor immune effect on infants under 2 years old and cannot induce immune memory. Coupling with carrier protein can convert polysaccharide antigen into T cell-dependent antigen, which is not only effective for infants, but also can induce immune memory. However, the production process of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/39A61K39/095A61K47/48A61P31/04A61K39/385
Inventor 许洪林王潇潇
Owner NAT VACCINE & SERUM INST
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