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

A seasonal influenza and combined vaccine technology, which is applied in the field of combined seasonal influenza and pandemic influenza vaccines for humans and its preparation, can solve the problems of difficult large-scale vaccination of bird flu vaccines, and achieve low production costs, simple methods, and large-scale production. The effect of social and economic benefits

Active Publication Date: 2013-09-11
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 b...

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] Production and verification facilities, raw materials and auxiliary materials, water, equipment, experimental animals, etc. should meet the relevant requirements of the "General Rules" in the third part of the "Chinese Pharmacopoeia" 2010 edition.

[0030] 2.1 Chicken embryos for production

[0031] The chicken embryos used for subculture and preparation of virus seeds are from SPF chickens; the chicken embryos used for vaccine production should be from healthy chickens raised in closed houses, and chicken embryos with no deformities, clear blood vessels, and activities at 9 to 10 days old are selected.

[0032] 2.2 Poison Seeds

[0033] 2.2.1 Name and source

[0034] Seasonal influenza strains are the seasonally popular influenza A and B strains recommended and provided by WHO; avian influenza strains are NIBRG-14 (A / Vietnam / 1194) recommended and provided by the World Health Organizatio...

Embodiment 2

[0147] Example 2 Immunogenicity of vaccines

[0148] The combination vaccine obtained in Example 1 and the monovalent stock solution are used as antigens, and SPF grade BABL / c mice are used as animal models, and the immunogen of the vaccine is determined according to the changes in the hemagglutination inhibitory antibody titers of different serotypes of HA in the mouse serum after immunization sex. The mice were immunized with the combination vaccine or the monovalent vaccine stock solution after gradient dilution, and the experimental groups were combined vaccine 0.3μg, 0.15μg, 0.075μg; combination vaccine plus aluminum adjuvant 0.3μg, 0.15μg, 0.075μg; H1N1, H3N2, B, H5N1 Type monovalent stock solution 0.3 μg, 0.15 μg, 0.075 μg; H1N1, H3N2, B, H5N1 type monovalent stock solution plus aluminum adjuvant 0.3 μg, 0.15 μg, 0.075 μg; PBS control group. Ten 5-week-old BALB / c mice in each group were subcutaneously injected with 0.1ml / mouse, and boosted once 21 days after the initia...

Embodiment 3

[0168] The safety of embodiment 3 vaccine

[0169] The combination vaccine has been passively tested in accordance with the relevant provisions of the "Measures for the Administration of Drug Registration" on the classification of biological products and the requirements for application materials, and with reference to the provisions of the "Technical Guidelines for Chemical Drug Irritation, Allergy and Hemolysis Research". Skin allergy test (PCA) and systemic active allergy test (ASA) to investigate animal allergy tests.

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

[0171] According to the nature of the antigen, 300~400g guinea pigs were selected as experimental animals in this experiment, and negative and positive control groups and groups with different doses of the test substance were set up for subcutaneous immunization. Combined vaccine high-dose group: 15 μg hemagglutinin antigen / rat, combined vaccine low-dose group: 3 μg hemagglutinin antigen / rat, positive control: b...

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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 seasonal influenza and pandemic influenza vaccine for humans 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), the number of influenza cases in the world is 600 million to 1.2 billion every year, and 500,000 to 1 million people die, which has brought serious harm to human health. harm. Since Perroncito first reported chickens infected with avian influenza virus in Italy in 1878, cases of avian influenza being transmitted from birds to humans have occurred worldwide from time to time. In 1997, it was discovered in Hong Kong, China, that the H5N1 avian influenza virus broke through the interspecies barrier to infect humans for the first time and caused death. A total of 404 people were infected with H5N1 bird flu in 15 countries around the world, 254 died, and the m...

Claims

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Application Information

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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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