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Hepatitis A, hepatitis B and hepatitis E combination vaccine

A hepatitis A and hepatitis B technology, applied in the field of hepatitis A-hepatitis B-hepatitis E combined vaccine and its preparation, to achieve good safety and immunogenicity, increase coverage, reduce production costs and market price effect

Active Publication Date: 2007-12-12
滁州方舟药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the development of the hepatitis A-hepatitis B-hepatitis E combined vaccine (HAV-HBV-HEV combined vaccine) as viral hepatitis has not been reported at home and abroad so far.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] A HAV-HBV-HEV combined vaccine, comprising inactivated hepatitis A antigen and recombinant hepatitis B antigen and recombinant hepatitis E antigen. Its inactivated HAV content is 200-1000U / mL, and the preferred dosage is 500U / mL; its recombinant HBsAg is 10-40 μg / mL, and its preferred dosage is 20 μg / mL; its recombinant hepatitis E virus protein content is 10-50 μg / mL. mL, the preferred dose is 20 μg / mL.

[0014] This embodiment also includes an immune adjuvant, which is an aluminum hydroxide gel solution, and the concentration range of the aluminum hydroxide gel is adjusted to 0.6-1.5 mg / mL, preferably 1.0 mg / mL.

[0015] The above-mentioned inactivated hepatitis A vaccine is prepared by purifying and inactivating HAV HM175 strain or other available vaccine strains.

[0016] Recombinant HBsAg is the genetically engineered recombinant protein expressed by yeast cells, mammalian cells, or other available cells, characterized in that any HBsAg or its fragments including ...

Embodiment 2

[0027] A method for preparing the above-mentioned HAV-HBV-HEV combined vaccine:

[0028] (a) Before preparing the final HAV-HBV-HEV combined vaccine, adsorb inactivated HAV on aluminum hydroxide gel, adsorb recombinant HBsAg on aluminum hydroxide gel, and adsorb recombinant HEV protein on aluminum hydroxide gel , adjust the pH to 5.5-9.6;

[0029] (b) The above-mentioned components whose pH was adjusted are mixed.

[0030] Further examples are given below.

Embodiment 3

[0031] Embodiment 3: the preparation of inactivated HAV stock solution

[0032] According to the vaccine preparation requirements, the human diploid fibroblast MRC5 was used to culture the cells of the HAV vaccine strain HM175, and the cultured virus was purified and inactivated with formalin. The specific preparation method and technical route are as follows:

[0033] (1) Culture human diploid fibroblast MRC5. After the cells grow into a monolayer, wash the cell monolayer with Hanks' solution to remove residual calf serum, inoculate HAV vaccine strain HM175, and adsorb for 2 hours at 37°C. Discard the inoculum, wash again, then add calf serum-free culture medium, incubate at 37°C, harvest when the cytopathic changes reach "+++", freeze and thaw 3 times and centrifuge to prepare HAV seed batches, use plaque The infection titer was titrated by the test, and stored at low temperature after subpackaging;

[0034] (2) As mentioned above, a large amount of HAV vaccine strain HM175...

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PUM

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Abstract

A combined vaccine for treating hepatitis a, hepatitis b and hepatitis e is characterized in comprising deactivated hepatitis a virus 200-1000 U / mL, recombined hepatitis b virus surface antigen 10-40 mu g / mL, and recombined hepatitis e virus antigen 10-50 mu g / mL.The inventive combined vaccine uses deactivated HAV and recombined HBsAg with good safety and immunogenicigy. Former research has provn that the recombined HEV protein also has good safety and immunogenicigy; and can be used for development of hepatitis e vaccine. The inventive combined vaccine is technologically feasible. The invention can greatly reduce production costs of viral hepatitis vaccine and market price, and improve coverage ratio of vaccine due to the advantages of convenience, multiple effect and low cost.

Description

1. Technical field [0001] The invention belongs to a combination vaccine and a preparation method thereof, in particular to a hepatitis A-hepatitis B-hepatitis E combination vaccine and a preparation method thereof. 2. Background technology [0002] Viral hepatitis is an infectious disease mainly caused by liver damage caused by a variety of hepatitis viruses, which is prevalent all over the world. Hepatitis A (HAV) is an acute viral hepatitis caused by the hepatitis A virus (HAV), which is mainly transmitted through the fecal-oral route. In 1988, the acute hepatitis A pandemic was caused by eating cockles in Shanghai, and more than 300,000 cases of hepatitis A occurred; hepatitis B (hepatitis B) is caused by hepatitis B virus (HBV) infection and is widely prevalent in all parts of the world. In endemic areas, the main harm of hepatitis B is that except for fulminant hepatitis, it becomes a chronic virus carrier after infection, and further develops into chronic hepatitis or...

Claims

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Application Information

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IPC IPC(8): A61K39/29A61K39/295A61P1/16A61P31/14A61P31/20
CPCY02A50/30
Inventor 孟继鸿戴星董晨贺锋
Owner 滁州方舟药业有限公司
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