Typhoid and paratyphoid A and B polysaccharide-protein conjugated polyvalent combined vaccine

A polysaccharide protein, type A and type B technology, applied in the direction of carrier binding antigen/hapten components, drug combinations, bacterial antigen components, etc., can solve the problem that vaccines cannot provide population protection, reduce the number of times, simplify immunization procedures, protect Wide range of effects

Inactive Publication Date: 2015-05-06
云南沃森生物技术股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the migration of pathogenic strains, monovalent typhoid and paratyphoid series vaccines cannot provide l...

Method used

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  • Typhoid and paratyphoid A and B polysaccharide-protein conjugated polyvalent combined vaccine
  • Typhoid and paratyphoid A and B polysaccharide-protein conjugated polyvalent combined vaccine
  • Typhoid and paratyphoid A and B polysaccharide-protein conjugated polyvalent combined vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Preparation of Example 1 Typhoid Vi polysaccharide, Paratyphoid A O-SP and Paratyphoid B O-SP

[0023] 1.1 Preparation of typhoid Vi polysaccharide

[0024] Salmonella typhi was cultured by fermentation in large tanks. After formaldehyde was sterilized, the culture supernatant of Salmonella typhi culture was harvested by centrifugation, and typhoid fever was initially extracted from the supernatant of Salmonella typhi culture by cetyl ammonium bromide method. Vi polysaccharide, and then through cold phenol extraction or column chromatography, the typhoid Vi polysaccharide is refined and purified. The cetyl ammonium bromide method and cold phenol extraction were according to the methods in the "Chinese Pharmacopoeia" 2010 edition three monographs in the production and inspection regulations of typhoid Vi polysaccharide vaccine.

[0025] 1.2 Preparation of paratyphoid A O-specific polysaccharide (ie paratyphoid A O-SP), type B paratyphoid fever O-specific polysaccharide ...

Embodiment 2

[0030] Example 2 Preparation of typhoid Vi polysaccharide protein conjugate stock solution, paratyphoid fever O-SP protein conjugate stock solution and paratyphoid fever B O-SP protein conjugate stock solution

[0031] 1. Preparation of paratyphoid A O-SP-TT conjugate stock solution and paratyphoid B O-SP-TT conjugate stock solution

[0032]O-SP reacts with adipic acid dihydrazide (ADH) to form O-SP-ADH derivatives, tetanus toxoid (TT) is purified by column chromatography, and the purified TT is mixed with O-SP-ADH to obtain a total Conjugation reaction to obtain O-SP-ADH-TT conjugates. The conjugate is purified by column chromatography to remove impurities to obtain the stock solution of the O-SP-TT conjugate. The raw solutions of paratyphoid O-SP-TT conjugates were purified by column chromatography, sterilized by 0.2 μm membrane filtration and preserved. The preparation method of each paratyphoid O-SP-TT conjugate stock solution is the Synthesis, Characterization, and Immu...

Embodiment 3

[0035] Embodiment 3 Vaccine finished product preparation

[0036] 1. Preparation of auxiliary materials

[0037] ① 0.1mol / L sodium hydroxide: Weigh 1 gram of sodium hydroxide in a 500ml container, dry-roast to depyrogenate, add appropriate amount of water for injection to dissolve, cool to room temperature and set the volume to 250ml.

[0038] ②Preparation of glycine solution: Weigh 70 grams of pharmaceutical grade glycine, dissolve it in an appropriate amount of water for injection, adjust the pH to 7.3±0.1 with 0.1mol / L sodium hydroxide, adjust the volume to 350ml, and sterilize and filter with a 0.2μm membrane. have to.

[0039] ③Sodium chloride solution: Weigh 5 grams of pharmaceutical grade sodium chloride into a 500ml container, dry-roast to depyrogenate, add an appropriate amount of water for injection to dissolve, and set the volume to 250ml.

[0040] ④0.01mol / L Phosphate Buffer (PB Buffer): Weigh 0.276 grams of disodium hydrogen phosphate (heptahydrate), 0.063 grams...

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Abstract

The invention discloses a typhoid and paratyphoid A and B polysaccharide-protein conjugated polyvalent combined vaccine. The active ingredients of the vaccine include typhoid Vi polysaccharide, paratyphoid A O-SP and paratyphoid B O-SP of salmonella as well as corresponding carrier proteins to form a conjugate. The preparation of the polyvalent combined vaccine comprises preparation combination of the polysaccharide-protein conjugate of three bacteria, dosage selection and preparation of a finished product. The results of animal experiments show that the polyvalent combined vaccine, after being injected to tested animals, can promote the tested animals to generate a high-level anti-paratyphoid A and anti-paratyphoid B lipopolysaccharide antibody (Anti-LPS IgG) and an anti-typhoid Vi polysaccharide (Anti-Vi IgG), and after boosting immunization, the vaccine has immunologic memory response and immune persistence. Meanwhile, upon vaccine safety evaluation, animal abnormal toxicity test, animal allergy test and heat source detection prove the safety and the effectiveness of the polyvalent combined vaccine.

Description

technical field [0001] The invention belongs to the technical field of vaccine products, in particular to a combined vaccine variety containing typhoid, paratyphoid A and paratyphoid B polysaccharide-protein conjugates. Background technique [0002] Typhoid fever and paratyphoid fever are acute systemic infectious diseases caused by Salmonella typhi (Salmonella typhi) and Salmonella paratyphi A, B, and C (Salmonella paratyphi A, B, C). It is one of the Class B infectious diseases that are required to be reported, and it is also a common public health problem faced by the world, especially in developing countries. Among them, Salmonella typhi, Salmonella paratyphi A, Salmonella paratyphi B, and paratyphoid C were occasionally reported. Pathogenic bacteria are generally transmitted through contaminated water, food, daily contact, flies and cockroaches, often causing bacteremia and causing outbreaks and sporadic epidemics. People of all age groups are generally susceptible to...

Claims

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Application Information

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IPC IPC(8): A61K39/385A61K39/116A61K39/112A61P31/04A61P37/04
CPCY02A50/30
Inventor 李生迪马波吴凯陈玉秋王铭吴俊波金栋包南艳钱雯
Owner 云南沃森生物技术股份有限公司
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