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Combined vaccine of seasonal influenza and pandemic influenza for people and preparation method

A technology for seasonal influenza and combined vaccine, which is applied in the field of combined seasonal influenza and pandemic influenza vaccine for human use and its preparation field, can solve the problems such as difficulty in large-scale vaccination of avian influenza vaccine, and achieves low production cost, simple method and large scale. social and economic effects

Active Publication Date: 2015-02-25
WUHAN INST OF BIOLOGICAL PROD CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, if we add H5N1 avian influenza strains to the annual seasonal influenza vaccine strains to produce combined seasonal influenza and pandemic influenza vaccines, the cost will only increase by about one-third of the original seasonal influenza vaccine. It is easier to be accepted by consumers, and it is a good solution to the current difficulty of large-scale vaccination of bird flu vaccines

Method used

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  • Combined vaccine of seasonal influenza and pandemic influenza for people and preparation method
  • Combined vaccine of seasonal influenza and pandemic influenza for people and preparation method
  • Combined vaccine of seasonal influenza and pandemic influenza for people and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1 Preparation of combined vaccine

[0028] 1 Basic requirements

[0029] The production and verification facilities, raw materials and auxiliary materials, water, utensils, laboratory animals, etc. should meet the relevant requirements of the “general” in the 2010 edition of the Chinese Pharmacopoeia.

[0030] 2.1 Chicken embryos for production

[0031] The embryos for virus seed passage and preparation are derived from SPF chickens; the embryos for vaccine production should be from healthy chickens raised in closed houses, and the embryos of 9-10 days old without deformities, clear blood vessels, and mobile are selected.

[0032] 2.2 Virus seeds

[0033] 2.2.1 Name and source

[0034] Seasonal influenza strains are seasonal influenza A and B strains recommended and provided by the WHO; avian influenza strains are NIBRG-14 (A / Vietnam / 1194) recommended and provided by the World Health Organization (WHO) / 2004 (H5N1)) virus strain.

[0035] 2.2.2 Establishment of seed batch

...

Embodiment 2

[0147] Example 2 Immunogenicity of vaccine

[0148] Using the combined vaccine and monovalent stock solution obtained in Example 1 as the antigen, SPF BABL / c mice were used as the animal model, and the immunogen of the vaccine was determined according to the changes in the titers of HA hemagglutination inhibitors of different serotypes in the sera of the mice after immunization Sex. The combined vaccine or monovalent vaccine stock solution was diluted to immunize mice. The experiment was divided into combined vaccine 0.3μg, 0.15μg, 0.075μg; combined vaccine plus aluminum adjuvant 0.3μg, 0.15μg, 0.075μg; H1N1, H3N2, B, H5N1 Type monovalent stock solution 0.3μg, 0.15μg, 0.075μg; H1N1, H3N2, B, H5N1 type monovalent stock solution plus aluminum adjuvant 0.3μg, 0.15μg, 0.075μg; PBS control group. Each group of 10 BALB / c mice aged 5 weeks, subcutaneously injected, 0.1ml / mouse, boosted once 21 days after the initial immunization, on the 0th day, 7th day, 14th day, 21st day, 28th day af...

Embodiment 3

[0168] Example 3 Safety of vaccine

[0169] According to the relevant provisions of the biological product registration classification and application data requirements in Annex 3 of the "Administrative Measures for Drug Registration", the combined vaccine has been passively implemented with reference to the provisions of the "Technical Guidelines for the Research on the Irritability, Allergy and Hemolysis of Chemical Drugs" Skin allergy test (PCA) and systemic active allergy test (ASA) to investigate animal allergy tests.

[0170] 1. Passive skin allergy test (PCA)

[0171] In this experiment, 300~400g guinea pigs were selected as experimental animals according to the nature of the antigen, and negative and positive control groups and different dose groups of the test substance were set up for subcutaneous immunization. Combination vaccine high-dose group: 15μg hemagglutinin antigen / mouse, combined vaccine low-dose group: 3μg hemagglutinin antigen / mouse, positive control: bovine s...

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Abstract

The invention discloses a combined vaccine of seasonal influenza and pandemic influenza for people. The hemagglutinin concentration of each vaccine is 10-60 mug / ml of H1N1 human influenza vaccine,10-60 mug / ml of H3N2 human influenza vaccine, 10-60 mug / ml of B human influenza vaccine, and 10-60 mug / ml of H5N1 human influenza vaccine respectively. The invention also discloses a preparation method of the combined vaccine. The combined vaccine disclosed by the invention has high safety; the problem that the traditional avian influenza vaccine is difficultly vaccinated at a large scale is solved; explosive epidemics of the H5N1 human influenza vaccine is effectively prevented and controlled when the seasonal influenza is prevented; the combined vaccine has great social and economic benefits.

Description

Technical field [0001] The invention relates to a combined human seasonal influenza and pandemic influenza vaccine and a preparation method thereof. Background technique [0002] For a long time, the incidence of influenza has remained high. According to the announcement issued by the World Health Organization (WHO), there are 600 million to 1.2 billion influenza cases worldwide and 500,000 to 1 million deaths each year, which has brought serious consequences to human health. harm. Since Perroncito first reported that chickens in Italy were infected with avian influenza in 1878, cases of avian influenza transmitted from birds to humans have occurred worldwide. Since the H5N1 avian influenza virus was found in Hong Kong, China in 1997 to break through the interspecies barrier to infect humans and cause deaths, the epidemic has become increasingly serious. The report released by the WHO shows that from January 2, 2003 to February 2, 2009 A total of 404 people were infected with H...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/295A61K39/145A61P31/16
Inventor 黄晓媛赵巍喻刚杨晓明
Owner WUHAN INST OF BIOLOGICAL PROD CO LTD
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