Immunogenic composition and preparation method thereof

A technology of immunogenicity and composition, which is applied in the field of biological product preparation, can solve problems such as time-consuming and labor-intensive, and achieve the effects of saving time and human resources, preventing polio and meningitis, and saving the number of inoculations

Inactive Publication Date: 2016-11-09
SINOVAC RES & DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The two vaccines are multi-dose immunization, and the recipients need to be vaccinated multiple times, which is time-consuming and labor-intensive

Method used

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  • Immunogenic composition and preparation method thereof
  • Immunogenic composition and preparation method thereof
  • Immunogenic composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] The cultivation of embodiment 1 Sabin poliovirus

[0034] The poliovirus strains sabin type I, sabin type II, and sabin type III provided by ATCC in the United States were adapted to grow in Vero cells in a 10-layer cell factory and continuously passaged, using MEM medium plus 8% calf serum (v / v ), cultured in an incubator at 37°C for 4 days, then replaced with serum-free M199 medium, received sabin strain type I, type II and type III viruses respectively according to MOI=0.01, harvested the virus liquid after culturing at 33°C for 3 days, and clarified and filtered use CCID 50 The virus titer value was detected by the method. The above three types of poliovirus harvest liquid can be stored in 7-8LgCCID 50 / ml range. At the same time, the virus harvest liquid was tested for D antigen value by D antigen ELISA double antibody sandwich detection method. The D antigen content of the above three types of poliovirus harvest liquid is in the range of 40-110 DU / ml.

Embodiment 2

[0035] Purification and inactivation of embodiment 2 Sabin poliovirus

[0036] The poliovirus harvest liquid obtained in Example 1 was subjected to three-stage clarification and filtration, and filter membrane packs of 0.75 μm, 0.45 μm and 0.22 μm were selected; the clarified and filtered feed liquid was subjected to two-stage ultrafiltration concentration, and the first stage was selected The 100KD polyethersulfone membrane bag is concentrated 40 times, and the second stage uses a 100KD polyethersulfone membrane bag to concentrate again 10 times; then the concentrated feed solution is passed through a molecular sieve chromatography column, and the column filler is Sephadex CL-6B, with 0.1 M PBS (pH 7.0) buffer for equilibration, and then continue to elute with 0.1M PBS (pH 7.0), and collect the first peak as the virus peak. Add the collected virus liquid to a chromatographic column equipped with DEAE Sepharose Fast Flow equilibrated with 0.1M PBS (pH 7.0), elute with 0.1M PBS...

Embodiment 3B

[0037] Cultivation and polysaccharide purification of Haemophilus influenzae type B of embodiment 3

[0038] According to the description of the culture method of Haemophilus influenzae type b in the Chinese patent No. 200810125160, it includes 2 times of pre-cultivation on solid medium and 1 time of pre-cultivation of liquid medium, and then culture and harvest in the fermenter . According to the description of the purification method of Haemophilus influenzae type b polysaccharide in this patent, it includes formalin treatment of the harvested liquid, centrifugation to collect the antigen supernatant and concentration, followed by a series of chemical methods to obtain purified b Haemophilus influenzae type polysaccharide, wherein the mass ratio of Hib polysaccharide protein antigen to carrier protein is 1:2-2:1.

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Abstract

The invention provides an immunogenic composition and belongs to the technical field of preparation of biological products. The immunogenic composition contains an inactivated poliomyelitis antigen and a type b haemophilus influenzae proteoglycan protein conjugate. The immunogenic composition can further contain a hepatitis b antigen and a physiologically acceptable carrier. The invention further provides a preparation method of the immunogenic composition. The immunogenic composition provided by the invention can be used for preventing infection of a plurality of types of pathogens at the same time; the antigens do not have a mutual interference phenomenon; the corresponding immunogenicity is not reduced when being compared with the immunogenicity excited by a single antigen; when the immunogenic composition provided by the invention is used, a vaccine inoculation program can be remarkably simplified, the inoculation efficiency is improved and the cost is reduced.

Description

technical field [0001] The invention relates to the technical field of biological product preparation, in particular to an immunogenic composition and a preparation method thereof. Background technique [0002] Poliomyelitis is a highly contagious disease caused by a virus that infects people. The polio virus can infect the nervous system of the human body, and can cause paralysis of the patient's limbs within a few hours, resulting in permanent disability. Poliomyelitis can occur in people of all ages, but it is more common in infants and young children under 5 years old, so the disease is also called "poliomyelitis". Poliovirus belongs to the Enterovirus genus of the Picornaviridae family, and can be classified into types I, II, and III according to serotypes, all of which can cause disease. So far, there is no specific drug for the treatment of polio in the medical field, but polio can be prevented by vaccination. [0003] The inactivated polio vaccine (IPV) was first ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/295A61K39/102A61K39/29A61K39/385A61P31/14A61P31/06A61P31/20
CPCA61K39/102A61K39/12A61K39/385A61K2039/55505A61K2039/6031A61K2039/70C12N2730/10134C12N2770/32334Y02A50/30
Inventor 董高峰张星星高强尹卫东
Owner SINOVAC RES & DEV
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