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Rotavirus vaccine and preparation method thereof

A rotavirus, virus technology, applied in the direction of antiviral agents, virus antigen components, etc., can solve the problem of which type of virus and infection cannot be detected.

Inactive Publication Date: 2013-07-03
SHANGHAI ZERUN BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In recent years, many children have chosen to be vaccinated against rotavirus. However, there are many types of rotavirus. The current testing equipment can only detect the virus, but cannot find out which type of virus it belongs to. Therefore, there is still a chance after vaccination. Infection, but even if infected after vaccination, there is an 80% chance of avoiding severe illness

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] From the liquid nitrogen container, take out the Vero cell strain (source, National Institute for the Control of Pharmaceutical and Biological Products), centrifuge at 1000rpm for 10 minutes, discard the original preservation solution, and add MEM nutrient solution containing 10% neonatal bovine serum and 0.20% hydrolyzed milk protein (pH with 7% NaHCO 3 Adjust to 6.8) and culture at 37°C until the cells grow into a single layer, then wash with PBS, digest with trypsin-EDTA, add the above nutrient solution, and subculture once every 5 days at a seeding rate of 1:2 until a batch is obtained. Produce enough cells for use.

[0016] In the above cell culture concentration up to 1010 6 / / ml, use 20μg / ml trypsin to pre-treat at 37°C for 30 minutes, add human rotavirus strains to the culture medium with pH 7.4 at a split rate of 0.05 MOIM.O.I., and statically adsorb and cultivate 3 days. After the culture period expired, the virus-cell culture suspension was obtained by dig...

Embodiment 2

[0018] With the aluminum phosphate adjuvant of the above-mentioned embodiment 1 method, inactivated virus vaccine and vaccine composition (inactivated virus vaccine+aluminum phosphate adjuvant) are respectively immunized mice, each immunization 0.5ml, 0 day, 21 days respectively immunize twice The second time, after 50 days of observation, blood was collected to detect serum neutralizing antibodies and titers.

[0019] Table 1

[0020] Vaccine Type

[0021] Therefore, explain that aluminum phosphate adjuvant can obviously increase the potency effect of rotavirus inactivated vaccine, play the effect of enhancing immunity, can greatly reduce the antigenic amount of purified stock solution of human rotavirus inactivated vaccine in the preparation of vaccine, has Good protective effect.

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Abstract

The invention provides an inactivated vaccine for a human rotavirus, wherein the vaccine contains capsid protein produced from cracking of rotavirus totivirus particles, and the viral protein in each dose of the inactivated vaccine for the human rotavirus is 100-200 [mu]g, and the aluminum phosphate adjuvant is 0.5 mg per dose. Compared with an existing virus purification stoste, the impure protein in the inactivated vaccine for the human rotavirus is greatly reduced, and the rotavirus vaccine has higher immunogenicity and potency, is safer to use and is more applicable to large-scale production.

Description

technical field [0001] The invention belongs to the field of biotechnology, and in particular relates to a human rotavirus vaccine and a preparation method thereof. Background technique [0002] Rotavirus is a segmented double-stranded RNA virus with a spherical exterior and a diameter of 70nm. It has a stable structure, double-layer capsid, heat resistance, and acid and alkali resistance. [0003] Rotavirus is one of the main pathogens causing diarrhea in infants and young children. It mainly infects the epithelial cells of the small intestine, causing cell damage and diarrhea. Rotavirus is seasonally prevalent in the cold season, and the route of infection is the fecal-oral route. The clinical manifestations are acute gastroenteritis, osmotic diarrhea, etc. There is an incubation period of about two days before symptoms develop. Symptoms usually begin with vomiting, followed by four to eight days of profuse diarrhea. Severe diarrhea can cause dehydration acidosis and ...

Claims

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Application Information

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IPC IPC(8): A61K39/15A61P31/14
Inventor 田平生刘瑞峰丛薇
Owner SHANGHAI ZERUN BIOTECHNOLOGY CO LTD
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