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Preparation method of tetravalent influenza virus split vaccine

A kind of influenza virus and virus technology, applied in the field of vaccines, can solve the problems of limited protective effect of type B virus, low purity of vaccine antigen, weak cross-protective effect, etc., and achieve the prevention and control of influenza epidemics, good protective effect and wide protection range Effect

Pending Publication Date: 2020-04-28
JIANGSU JINDIKE BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Before 2018, the seasonal influenza vaccines marketed in my country were dominated by influenza virus split vaccines, and all of them were trivalent vaccines. The marketed trivalent influenza vaccines contained two types of A and one type B strain (Yamagata or Victoria) ), due to the weak cross-protection between the Yamagata and Victoria strains of B viruses, the trivalent influenza vaccine containing one type B has limited protection against another lineage B virus
Most of the currently marketed influenza virus split vaccines use a two-step purification process (combination of ultra-fast zonal centrifugation and gel (column) chromatography, or a combination of two ultra-speed zonal centrifugation methods), and the purity of vaccine antigens produced by the two-step purification process is relatively high. low, and relatively high in ovalbumin (the main allergen in the flu vaccine)
[0006] In addition, there is still room for improvement in the immune effect and safety of the existing influenza split vaccines

Method used

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  • Preparation method of tetravalent influenza virus split vaccine
  • Preparation method of tetravalent influenza virus split vaccine
  • Preparation method of tetravalent influenza virus split vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] The preparation method of quadrivalent influenza virus split vaccine of the present invention comprises the steps:

[0066] 1) Harvesting liquid preparation: four influenza (flu) viruses recommended by the World Health Organization and approved by the drug regulatory department of the State Council, H1N1, H3N2, B1 (B / Victoria) and B2 (B / Yamagata) Strains were inoculated with 9-11 day-old healthy chicken embryos respectively, and after 33 35°C, 48 72 hours of culture (48 hours for type A, 72 hours for type B), 2 The virus fluid was harvested after chilling the embryos at 8°C.

[0067] 2) Virus inactivation: add formaldehyde with a final concentration of 200 μg / ml to the monovalent virus pool to inactivate the virus;

[0068] 3) Concentration by ultrafiltration: the inactivated harvest liquid is concentrated by ultrafiltration using a 1000KD ultrafiltration membrane bag to obtain a concentrated virus solution;

[0069] 4) Purification after concentration 1: first a...

Embodiment 2

[0085] Embodiment 2 Carry out control experiment with the vaccine of the preparation of embodiment 1 and comparative example 1

[0086] 1. Detection method of ovalbumin content:

[0087] 1) Before use, equilibrate all reagents to room temperature at room temperature for at least 30 minutes;

[0088] 2) Dilute the sample with the sample diluent, where the reference dilution multiples of the unit price stock solution are original times, 2.5 times, 5 times, and 10 times; the reference dilution multiples of semi-finished products and finished products are original times, 2.5 times, and 5 times; other samples are based on estimates If the measured values ​​of different dilutions are greater than the corresponding absorbance value of the standard 20ng / ml, the sample needs to be further diluted and determined so that the measured value is at the corresponding absorbance value of 0.31-20ng / ml interval;

[0089] 3) Take out the ELISA plate, and add 100 μl of HRP conjugate to each tes...

Embodiment 3

[0118] Example 3 Immune effect test

[0119] Clinical Trial Overview, Immunogenicity Study Endpoints, Immunogenicity Detection Methods

[0120] The S201510001-1 batch of quadrivalent influenza virus split vaccine prepared by the method of Example 1 was tested and qualified by the China Institute for Food and Drug Control before clinical trials. A randomized, double-blind, controlled Phase III clinical trial completed in China In the trial, a total of 3,664 subjects aged 3 and over were enrolled and randomly inoculated with one dose of this product's quadrivalent influenza test vaccine and two trivalent seasonal influenza control vaccines at a ratio of 2:1:1.

[0121] Blood samples were collected from the subjects before and 28 days after immunization, and the influenza virus HI antibody titer (GMT) of the subjects' serum was determined by the micro-hemagglutination inhibition test method.

[0122] The H1N1, H3N2, B(Y) and B(V) antibody GMTs of the whole study population in th...

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Abstract

The invention provides a preparation method of a tetravalent influenza virus split vaccine. The method comprises the following steps: 1) preparation of a harvesting liquid; 2) virus inactivation; 3) ultrafiltration and concentration; 4) first purifying after the concentration; 5) second purifying; 6) virus lysis; 7) third purifying after the lysis; 8) preparation of a semi-finished product; and 9)preparation of a finished product. The method has the technical effects that the method has the following technical effects: a tetravalent influenza virus split vaccine sample prepared by an optimized three-step purification process has lower ovalbumin content, lower impure protein content and high-purity hemagglutinin antigen, so that the adverse reaction of the tetravalent influenza virus splitvaccine is lower, the immune effect of the vaccine is better, and the safety of the vaccine is higher.

Description

technical field [0001] The invention relates to a preparation method of a quadrivalent influenza virus split vaccine, belonging to the technical field of vaccines. Background technique [0002] Influenza virus, a representative of Orthomyxoviridae, referred to as influenza virus, the shape of influenza virus is spherical, a few are filamentous, and its diameter is between 80 and 120 nanometers. The structure of influenza virus can be divided into envelopes from outside to inside. , matrix protein and core three parts. [0003] Before 2018, the seasonal influenza vaccines marketed in my country were dominated by influenza virus split vaccines, and all of them were trivalent vaccines. The marketed trivalent influenza vaccines contained two types of A and one type B strain (Yamagata or Victoria) ), due to the weak cross-protection between the Yamagata and Victoria strains of B viruses, the trivalent influenza vaccine containing one type B has limited protection against another ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/145A61K39/295A61P31/16C12N7/06C12R1/93
CPCA61K39/12A61K2039/5252A61K2039/5258A61K2039/70A61P31/16C12N7/00C12N2760/16134C12N2760/16163
Inventor 蒋正东吴建华陈科李振辉李岳勇赵越帅旗赵静夏建国余军
Owner JIANGSU JINDIKE BIOTECHNOLOGY CO LTD
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