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Vaccine containing capsular polysaccharide of type 5 streptococcus pneumoniae and preparation method thereof

A technology of Streptococcus pneumoniae and capsular polysaccharide, which can be used in medical preparations containing active ingredients, medical preparations without active ingredients, and antibacterial drugs, which can solve the risk of protein immunogenicity and loss of specific epitopes. , antigen destruction, etc.

Pending Publication Date: 2021-05-04
SINOVAC RES & DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The activation reaction is 10-30 minutes, and the binding reaction is 2-4 hours. The reaction is fast, but in addition to the carboxyl group, there are also amino groups on the carrier protein, and self-polymerization or cross-linking products between proteins are prone to occur in the amide condensation reaction
[0010] The two combined methods of reductive amination and amide condensation have their own advantages and disadvantages: the reductive amination reaction is relatively mild, the advantage is that there will be no protein self-polymerization, and the disadvantage is that NaIO 4 The oxidation of the polysaccharide may lead to the cleavage of the polysaccharide backbone and the loss of the epitope group, which will lead to the destruction of the antigen during the binding process, while the amide condensation reaction is relatively fast, and the activation stage will not cause antigen destruction, but the binding stage will not only generate polysaccharide-protein conjugates , there will be less effective conjugates of polysaccharide-protein-protein-polysaccharide, and the increase in the amount of carrier protein will also bring risks to the immunogenicity of multivalent vaccines
This way of first reduction is a kind of damage to the polysaccharide antigen, resulting in the loss of specific epitopes, which may cause the loss of immunogenicity and protective effect, and after the first reduction, the loss of polysaccharides is close to half

Method used

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  • Vaccine containing capsular polysaccharide of type 5 streptococcus pneumoniae and preparation method thereof
  • Vaccine containing capsular polysaccharide of type 5 streptococcus pneumoniae and preparation method thereof
  • Vaccine containing capsular polysaccharide of type 5 streptococcus pneumoniae and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] Example 1 Preparation of Streptococcus pneumoniae serotype 5 capsular polysaccharide-protein conjugate

[0073] Serotype 5 capsular polysaccharides can be obtained directly from bacteria using isolation methods known to those skilled in the art. Serotype 5 pneumococcus (Streptococcus pneumoniae) strains were obtained from China National Institutes for Food and Drug Control. The above strains were subcultured to build a library. The strains were inoculated in a liquid medium and cultured at 35±2°C. In the late logarithmic growth period, sodium deoxycholate was added to lyse the bacteria and release capsular polysaccharides, centrifuge, and collect the supernatant. Concentrate the supernatant 3-10 times by ultrafiltration with ultrafiltration membrane packs with a molecular weight cut-off of 100 or 300 kDa. Use a phosphate buffer solution with a pH of about 7.0 to replace the ultrafiltrate by ultrafiltration, then add absolute ethanol to make the final concentration of ...

Embodiment 2

[0122] Example 2 Evaluation of Streptococcus pneumoniae serotype 5 capsular polysaccharide-protein conjugates

[0123] Determination of the structural integrity of capsular polysaccharides: using the literature method (Talaga P, Vialle S, Moreau M. Development of a high-performance anion-exchange chromatography with pulsed-amperometric detection based quantification assay for pneumococcal polysaccharides and conjugates[J].Vaccine,2002, 20(19):2474-2484.), using ion chromatography to analyze the content of PnepNAc sugar in activated polysaccharides and bound polysaccharides, taking Fuc as an internal reference, and calculating the structural integrity, the results are shown in Table 7.

[0124] Evaluation of immunogenicity of capsular polysaccharide-protein conjugates: BALB / c mice of 18-22 g were immunized, the polysaccharide content of each immune substance was 2 μg / ml, and 10 mice were immunized in each group. Two injections of intraperitoneal immunization on days 0 and 14, 0...

Embodiment 3

[0130] Example 3 Preparation of multivalent pneumococcal capsular polysaccharide conjugate vaccine

[0131] Mix the type 5 monovalent conjugates prepared above with 1, 3, 4, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F monovalent conjugates, according to the final concentration of polysaccharide 4μg / ml, 6B The conjugates were mixed with each conjugate according to the final polysaccharide concentration of 8 μg / ml, and mixed with physiological saline as a solvent to prepare a 13-valent pneumonia polysaccharide conjugate vaccine preparation for injection. The 13-valent pneumococcal capsular polysaccharide conjugate vaccine prepared above is made into a freeze-dried dosage form by low-temperature drying, and reconstituted with physiological saline before use.

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Abstract

The invention provides a vaccine containing capsular polysaccharide of type 5 streptococcus pneumoniae and a preparation method of the vaccine, and belongs to the technical field of biological product preparation. The preparation method provided by the invention comprises the following steps: respectively degrading each serotype capsular polysaccharide at least containing type 5 streptococcus pneumoniae; performing activation; carrying out freeze-drying or precipitation; redissolving or dissolving the activated capsular polysaccharide of streptococcus pneumoniae, and conjugating the activated capsular polysaccharide with carrier protein; and purifying the conjugated vaccine stock solution. The antigen-specific epitope in the vaccine stock solution prepared by the method is not lost, the integrity of the antigen is maintained, the immunogenicity in the preparation process of the polysaccharide-protein conjugate is ensured not to be reduced to the greatest extent, and meanwhile, the generation of protein autopolymer is avoided. The streptococcus pneumoniae capsular polysaccharide-protein conjugate vaccine stock solution prepared by the method can be used for preparing streptococcus pneumoniae capsular polysaccharide monovalent and multivalent conjugate vaccines, and can also be used for preparing combined vaccines containing streptococcus pneumoniae capsular polysaccharide.

Description

technical field [0001] The invention belongs to the technical field of biological product preparation, and in particular relates to a vaccine containing type 5 Streptococcus pneumoniae capsular polysaccharide and a preparation method thereof. Background technique [0002] Streptococcus pneumoniae can cause invasive diseases such as meningitis and pneumonia and non-invasive diseases such as otitis media. At present, the main means of defense against Streptococcus pneumoniae are polysaccharide vaccines and conjugate vaccines. The protective effect of the former in adults has been confirmed, but the protection in infants and young children, the main susceptible population of Streptococcus pneumoniae, is weak. Because of their ability to elicit effective protection and immune memory in infants and young children, conjugate vaccines have been included in immunization programs or approved for marketing in many countries around the world since their first introduction in 2000, and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/09A61K39/385A61K47/64A61P31/04
CPCA61K39/092A61K39/385A61K47/64A61P31/04
Inventor 王新立韩振王治伟吕哲林纪胜高强王见冬韩星雷永红郭德乾隋晓斌
Owner SINOVAC RES & DEV
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