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Reinforced tuberculosis subunit vaccine

A subunit vaccine and enhanced technology, applied in the direction of bacterial antigen components, antibody medical components, antibacterial drugs, etc., can solve problems such as unsatisfactory needs, and achieve the effect of improving immune protection

Inactive Publication Date: 2014-09-10
NAT INST FOR FOOD & DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Considering that the immune mechanism of anti-tuberculosis is dominated by cellular immunity, the traditional aluminum adjuvant can no longer meet the demand

Method used

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  • Reinforced tuberculosis subunit vaccine
  • Reinforced tuberculosis subunit vaccine
  • Reinforced tuberculosis subunit vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1 Immunoprotective effect test

[0029] Materials and methods

[0030] 1. Experimental materials

[0031] 1. Mice and guinea pigs

[0032] Specific pathogen free (SPF) grade BALB / c mice (female, 6-8 weeks old) and SPF grade Hartley guinea pigs (half male and female, 300-400g) were purchased from the Experimental Animal Resource Center of the China Institute for Food and Drug Control. supply. Experimental animal use license number: scxk (Beijing) 2009-0017. During the experiment, they were kept in a negative pressure animal room that reached biosafety level III.

[0033] Reagent

[0034] Recombinant Mycobacterium tuberculosis protein Ag85b and recombinant Mycobacterium tuberculosis ESAT6-CFP10 fusion protein (EC) were prepared according to the method disclosed in patent document CN103386128A, BCG-CPG (prepared according to the method disclosed in Chinese patent 200410033878.1), and improved Roche medium, BCG The vaccine was produced by the Chengdu Institute...

Embodiment 2

[0061] Example 2 Immunotherapy Experiment of Guinea Pig Latent Infection Model

[0062] In view of the above results, the present invention evaluates Ag+Al+CpG+PolyI:C on the latent infection model of guinea pigs, that is, Ag85b (10 μg)+EC (10 μg)+Al(OH)3 (0.2mg)+CpG (75 μg)+ Immunotherapeutic effect of Poly I:C (50 μg) vaccine.

[0063] 1. Methods and steps

[0064] 1. Grouping and Immunization of Guinea Pigs

[0065] Table 2 Experimental groups of guinea pigs

[0066]

[0067] Note: EC is ESAT6-CFP10

[0068] 40 SPF grade Hartley guinea pigs (300-350g / guinea pig), half male and half male, were divided into 5 groups with 8 guinea pigs in each group. The guinea pigs were challenged subcutaneously with 5.0×10 3 After CFU Mtb, intragastric administration of isoniazid, 5 mg / cattle, 3 times a week, for 4 weeks in total. Then each group was injected with the corresponding vaccine according to the above table for treatment, a total of 6 injections, with an interval of 2 wee...

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Abstract

A provided reinforced tuberculosis subunit vaccine comprises mycobacterium tuberculosis antigen Ag85b protein, recombination mycobacterium tuberculosis ESAT6-CFP10, a BCG-CpG adjuvant, an aluminium adjuvant and a PolyIC adjuvant. The vaccine is capable of mitigating the pathological change degree of guinea-pig visceral organs infected by Mtb, and effectively inhibiting or killing mycobacterium tuberculosis latently infecting a guinea pig in the body.

Description

technical field [0001] The invention relates to an enhanced tuberculosis subunit vaccine, in particular to a novel subunit vaccine with Ag85b protein and ESAT6-CFP10 fusion protein as antigen components and BCG-CpG, aluminum and Poly IC as composite adjuvants. Background technique [0002] Tuberculosis is a chronic infectious disease caused by Mycobacterium tuberculosis infection. Mycobacterium tuberculosis may invade various organs of the human body, but mainly invades the lungs, which is called pulmonary tuberculosis. Tuberculosis, also known as tuberculosis and "white plague", is an ancient infectious disease, and tuberculosis has existed since human beings existed. [0003] my country is one of the 22 countries with a high burden of tuberculosis in the world. About one-third of the population has been infected with Mycobacterium tuberculosis, and the number of infected people exceeds 400 million. There are about 5 million tuberculosis patients in my country, mainly con...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/39A61K39/04A61P31/06
Inventor 王国治卢锦标都伟欣陈保文杨蕾苏城沈小兵
Owner NAT INST FOR FOOD & DRUG CONTROL
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