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Rotavirus vaccine for oral administration

A rotavirus and vaccine technology, applied in the direction of antiviral agents, viral antigen components, medical preparations of non-active components, etc., can solve the problems affecting the effectiveness and safety of vaccines, biological hazards, vaccine storage conditions and validity Limitation and other issues to achieve the effect of enhancing gastric acid resistance, good safety, and good immune response stimulation ability

Active Publication Date: 2013-09-25
SINOVAC RES & DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

First, they are potentially biologically hazardous, such as proteins or protein hydrolysates of animal or human origin with uncertain chemical composition
In addition, these existing compositions in this technical field fail to make the attenuated live vaccine have sufficient stability and acid resistance, so that the storage conditions and validity period of the vaccine are greatly limited, and even further affect the effectiveness and safety of the vaccine.
There is no report of a rotavirus vaccine suitable for oral administration and strong stability

Method used

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  • Rotavirus vaccine for oral administration
  • Rotavirus vaccine for oral administration
  • Rotavirus vaccine for oral administration

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] The preparation of embodiment 1 rotavirus antigen

[0037]The virus strain UK x D strain (G1), UK x DS-1 provided by the National Institute of Health (hereinafter referred to as NIH) to Beijing Kexing Zhongwei Biotechnology Co., Ltd. as the starting material strain of the vaccine strain (G2), UK x P strain (G3), UK x ST-3 strain (G4), UK x AU32 strain (G9) and UK x Wa strain (P1A[8]). MA-104 cells or diploid cells were adapted to grow and continuously passaged, cultured in a 37.5±1.0°C incubator for 2 to 5 days to harvest the virus liquid, clarified and filtered with CCID 50 The virus titer value was detected by fluorescent quantitative PCR method. The maximum yield of the above six serotypes of rotavirus can reach 10 6 -10 8 CCID 50 / ml. The purified rotavirus stocks of each serotype can be used to prepare vaccine preparations.

Embodiment 2

[0038] The preparation of embodiment 2 rotavirus vaccines

[0039] (1) Prepare 3M phosphate buffer solution (in which the molar concentration ratio of potassium dihydrogen phosphate and dipotassium hydrogen phosphate is 1:2) and 4M sodium succinate solution stock solution, filter and sterilize, and store at 2-8°C for later use;

[0040] (2) Mix 10ml of phosphate buffer prepared in step (1) with 15ml of sodium succinate solution;

[0041] (3) Add 150ml of 60% sucrose solution to (2);

[0042] (4) Add 100ml of the antigen solution in Example 1 to (3), which is a mixture of G1, G2, G3, G4, G9, and P1A[8];

[0043] (5) Supplement the volume to 300ml with virus-free, serum-free MEM culture medium; for vaccines, the pH value is 5-8;

[0044] (6) Filter and dispense, 3ml per dose, 100 doses in total.

[0045] Each dose of the vaccine prepared in this embodiment contains the following ingredients: 10 each of the above-mentioned 6 serotypes of rotaviruses 5 -10 7 CCID 50 , 30% su...

Embodiment 3

[0046] Embodiment 3 contains the antiacid effect of the rotavirus vaccine of different sucrose concentration formulations

[0047] (1) Preparation of vaccine preparations

[0048] Prepare 4 groups of vaccines containing different sucrose concentrations: Prepare 4 groups of 10ml 3M phosphate buffer solution (the molar concentration ratio of potassium dihydrogen phosphate and dipotassium hydrogen phosphate is 1:2) and 15ml 4M sodium succinate solution, and add to the 4 groups Sucrose solutions containing 30g, 90g, 150g, and 180g of sucrose were added to the mixed solution to prepare 4 kinds of protective agents containing different concentrations of sucrose (phosphate solution + sodium succinate solution + sucrose solution), and added to the 4 groups of protective agents The 100ml antigen component in Example 1 (same as Example 2, mixed with 6 serotypes) was filled up to 300ml with virus-free serum-free MEM maintenance solution, filtered and sterilized, and divided into 3ml dose...

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Abstract

The invention provides a rotavirus vaccine for oral administration. The rotavirus vaccine contains rotavirus antigen, carbohydrate, phosphate and carboxylate. The rotavirus vaccine for oral administration can be adopted to raise stability of vaccine antigenic components, has good stability at 37 DEG C, 2-8 DEG C and 25 DEG C, has stable antigen activity, can enhance stomach acid resistance after oral administration of the vaccine finished product, and has good immune response stimulating capability and good safety. The rotavirus vaccine contains no other humanized or animal-based protein, has better safety, requires lower cost, and is suitable for industrial production of the product.

Description

technical field [0001] The invention relates to the field of biotechnology, in particular to a rotavirus vaccine formulation suitable for oral administration. Background technique [0002] Rotavirus (RV) is the main cause of severe diarrhea and dehydration in infants and young children. It is an important public health problem in both developing and developed countries. There are about 600,000 deaths of children <5 years old in the world every year. Of the cases, 85% of the deaths were in developing countries. Rotavirus diarrhea not only causes social disease burden, but also brings huge economic losses. Even in developed countries, rotavirus infection in infants and young children is very common. Studies in the United States have found that the annual medical expenses related to rotavirus infection are as high as 352 to 1 billion US dollars. Implementing immunization would save $79 million in health care and $466 million in other areas of society. The survey in mainl...

Claims

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Application Information

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IPC IPC(8): A61K39/15A61K47/26A61K47/04A61P31/14
Inventor 戈小琴王一丁王楠张晓军张博韩星高强董珊珊尹卫东
Owner SINOVAC RES & DEV
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