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Allergy vaccine composition, production method thereof and use of same in allergy treatment

A vaccine composition and allergen technology, applied in the field of immunology, to achieve the effect of reducing the number of injections and shortening the time

Inactive Publication Date: 2009-09-16
INST FINLAY CENT DE INVESTIGACION PRODUCCION DE VACUNAS Y SUEROS +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Like usual adaptive immunity, the response induced by this vaccine is specific to the bacterial antigen contained in the product, so there is no evidence of induction of an immune response to common general allergens

Method used

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  • Allergy vaccine composition, production method thereof and use of same in allergy treatment
  • Allergy vaccine composition, production method thereof and use of same in allergy treatment
  • Allergy vaccine composition, production method thereof and use of same in allergy treatment

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Example 1. Acquisition and purification of mite allergens

[0052] Allergens were derived from whole mite cultures, including dead mites, scales, faecal particles, and low molecular weight media components. Extract the allergen in one of the following solutions: ammonium bicarbonate, sodium bicarbonate, phosphate-buffered saline, or saline with a pH near physiological. Crude extracts were clarified by centrifugation and filtration, and low molecular weight components were removed by gel filtration chromatography (Sephadex G-25) or diafiltration (cut-off: 5-10 kD) or both. Subsequently, the product was concentrated by ultrafiltration and freeze-dried to ensure its stability. For further purification of the allergen, the freeze-dried extract was resuspended in aqueous solution and subjected to salting out precipitation in 50-100% ammonium sulfate solution. The precipitate was resuspended in water and separated by gel filtration chromatography on Superdex 75. Intermedia...

Embodiment 2

[0053] Embodiment 2. Obtaining of proteoliposome

[0054] It starts with a N. meningitidis B culture. Biomass was harvested by centrifugation and extracted using detergents, enzymes and sonication. Cellular debris was removed by centrifugation and the supernatant was treated with nuclease digestion to remove nucleic acids. The extract was recovered by ultracentrifugation, resuspended in detergent solution, and purified by molecular separation chromatography to remove the remaining low and intermediate molecular weight components. The proteoliposomes obtained contained less than 10% nucleic acid and about 10% LPS embedded in their structure; but no free form. Optionally, capsular polysaccharide is added in a ratio of 0.5 to 4 times the proteoliposome content, which is derived from Gold and Gotschlich (Gold et al., 1969-1970, WHO Bull.45:279-282 and Gotschlich et al., 1969, J . Exp. Med. 129: 1349-1365) of Neisseria meningitidis serogroup C. Optionally, aluminum hydroxide is...

Embodiment 3

[0055] Example 3. Determination of Allergenicity (IgE Binding Activity) of Preparations Adsorbed on Aluminum Hydroxide

[0056]Allergenicity, expressed as the binding capacity of human IgE antibodies, can be determined by IgE-inhibition ELISA. This assay measures the ability of a sample solution to inhibit the binding of IgE to a solid phase coated with an allergen. In this case, the sample preparation used was D. siboney allergen purified according to Example 1, mixed with proteoliposomes obtained according to Example 2, and then adsorbed onto aluminum hydroxide gel. The initial Der s 1 allergen concentration was 4 μg / mL and the allergen activity was 400 BU / mL (BU: biological unit defined according to the 2nd edition of the Nordic Guidelines for the Registration of Allergenic Products. 10000 BU / mL in the SkinPrick Test Equivalent to 10mg / mL histamine hydrochloride.)

[0057] ELISA was performed according to the procedure described below. Polystyrene microplates were coated...

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Abstract

The present invention relates to the field of immunology, immuno-allergy and especially the use of adjuvants or carriers for modulating the immune response to allergens. The object of the present invention is to prepare a therapeutic or prophylactic pharmaceutical preparation using bacterial proteoliposomes which, when applied to allergic individuals, is able to switch Th2 and IgE dependent allergic responses into protective Th1 responses ; and it also prevents the emergence and development of allergies in still non-allergic individuals. The vaccine composition comprises proteoliposomes from Gram-negative bacteria coupled to an allergen and optionally other adjuvants or antigens. The present invention also relates to methods of preparing the inventive vaccine composition and a two-dose immunization regimen with said vaccine composition.

Description

technical field [0001] The present invention relates to the field of immunology, in particular the branch of immuno-allergy and especially the use of adjuvant or carrier compounds capable of modulating the immune response to allergens. The aim of the present invention is to induce changes in the specific response so as to reduce or prevent its pathogenic effects. Background technique [0002] Allergy is a very common pathology, mainly occurring in industrialized countries. Several mechanisms of immunopathology are involved in allergy, in particular so-called type I allergic hypersensitivity. The pathophysiology of type I hypersensitivity is based on increased production of a cytophilic antibody, IgE. After initial exposure, ie, sensitization, IgE antibodies are produced against foreign substances, ie, allergens. [0003] IgE antibodies can bind to IgE receptors on the surface of blood basophils and tissue mast cells, and their average lifespan extends from a few hours in ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/39A61K39/35A61P11/06
CPCA61K2039/55583A61K2039/57A61K2039/55594A61K2039/55505A61K39/35A61K2039/6018A61P37/00A61K39/39A61K38/16A61K9/127A61K39/395
Inventor M·D·S·J·拉斯特冈萨雷斯O·G·佩雷斯马丁A·莱伯瑞达罗萨多I·比多特马丁奈兹J·M·德尔坎伯艾隆索D·A·佩雷斯拉斯特E·菲森达拉莫斯C·扎亚斯维格尼尔C·罗德里格斯马丁奈兹V·G·希尔拉冈萨雷斯J·E·佩雷斯拉斯特G·R·布拉乔戈瑞纳达
Owner INST FINLAY CENT DE INVESTIGACION PRODUCCION DE VACUNAS Y SUEROS
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