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Multivalent immunogenic composition

A technology of immunogenicity and composition, applied in the field of medical biology, can solve problems such as time-consuming and labor-intensive

Active Publication Date: 2013-11-20
SINOVAC BIOTECH
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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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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] The cultivation of embodiment 1 hepatitis A virus

[0051] Hepatitis A virus (TZ84 strain or YN5 strain, from Beijing Kexing Biological Products Co., Ltd.), adapted to growth and serial passage in 2BS cells in a 10-layer cell factory, using EMEM medium plus 10% newborn bovine serum (v / v), placed After culturing in an incubator at 37.5±1.0°C for 5-7 days, inoculate hepatitis A virus according to MOI0.05, continue culturing at 37.5±1.0°C for 3-5 days, harvest the virus liquid, and detect the virus titer value by enzyme-linked immunosorbent assay after clarification and filtration . Hepatitis A virus harvest liquid can be in 6-8LgCCID 50 / ml range.

Embodiment 2

[0052] Purification and inactivation of embodiment 2 hepatitis A antigen

[0053] The hepatitis A virus harvest liquid described in Example 1 was subjected to three-stage clarification and filtration; the clarified and filtered feed liquid was subjected to ultrafiltration and concentration; The buffer was equilibrated, and then continued to be eluted with 0.1MPBS (pH7.2), and the first peak was collected as the virus peak. The collected virus fluid was filtered through 0.22 μm and inactivated with 1:4000 formaldehyde at 37°C for 12-13 days, and finally the vaccine stock solution was obtained after sterile filtration.

Embodiment 3

[0054] The cultivation of embodiment 3 Sabin poliovirus

[0055] The poliovirus strains sabin I, sabin II, and sabin III provided by ATCC in the United States were respectively adapted to growth in Vero cells in a 10-layer cell factory and continuously passaged, using MEM medium plus 10% calf serum (v / v), placed in After culturing in an incubator at 37.5±1.0°C for 3-5 days, replace the serum-free M199 medium, inoculate sabin strain type I, type II and type III viruses respectively according to MOI=0.01, harvest the virus liquid after culturing at 32.5°C for 3-4 days, and pass through Clarify and filter with 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 r...

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Abstract

The invention provides a multivalent immunogenic composition, which includes an inactivated hepatitis A antigen and an inactivated poliovirus. The composition also can further include over one or two of a purified pertussis antigen, diphtheria toxoid, tetanus toxoid, filamentous hemagglutinin, Haemophilus influenzae type b polysaccharide, Neisseria meningitidis capsular polysaccharide, a hepatitis B virus antigen, enterovirus 71 and a coxsackievirus A16 antigen, and a physiologically acceptable carrier. The composition involved in the invention is employed to immunize the inoculated population in the form of a bivalent vaccine or more combined vaccines. Without reducing the immune effects of each immunizing antigen, the inoculation number of times can be reduced at the same time, and the time and human resources can also be saved.

Description

technical field [0001] The invention relates to the field of medical biotechnology, in particular to a multivalent immunogenic composition. Background technique [0002] Viral hepatitis A, referred to as hepatitis A, is an acute infectious disease caused by hepatitis A virus (HAV), and fecal-oral transmission is its main route of transmission. The clinical manifestations are acute onset, chills, fever, loss of appetite, nausea, fatigue, hepatomegaly and abnormal liver function. Jaundice occurs in some cases, and asymptomatic infection cases are more common, and generally do not turn into chronic and pathogen-carrying states. [0003] Hepatitis A virus belongs to the Picornaviridae family and the Hepavirus genus. The virus particle is spherical, with a diameter of about 27nm, without an envelope, and the capsid is composed of 32 capsomers, which are icosahedral. Each capsicle has four polypeptides, namely viral proteins VP1, VP2, VP3 and VP4. It is a single-stranded positi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/29A61K39/13A61K39/295A61K39/05A61K39/08A61K39/10A61K39/102A61K39/095A61K39/125A61P1/16A61P31/14
CPCY02A50/30
Inventor 董珊珊高强王一丁姜德玉赵崇伯戈小琴韩星尹卫东
Owner SINOVAC BIOTECH
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