Russian Journal of AllergyRussian Journal of AllergyРоссийский Аллергологический Журнал1810-88302686-682XPublishing House ABV Press80310.36691/RJA803ArticlesСтатьиMODERN PROBLEMS OF ALLERGEN VACCINES STANDARDIZATIONСовременные проблемы стандартизации аллерговакцинZheltikovaTat'yana MikhaylovnaЖелтиковаТатьяна Михайловна

НИИ вакцин и сывороток им. И.И. Мечникова РАМН, г. Москва

t-zheltikova@yandex.ruHrabinaM

Отдел науки и медицины, Сталлержен, Франция

AntropovaA BАнтроповаА Б

НИИ вакцин и сывороток им. И.И. Мечникова РАМН, г. Москва

ZheltikovaT M

Mechnikov Research Institute for Vaccines and Sera of the Russian Academy of Medical Sciences

HrabinaM

Departement Scientifique et Medical, Stallergenes S.A., Antony, France

AntropovaA B

Mechnikov Research Institute for Vaccines and Sera of the Russian Academy of Medical Sciences

НИИ вакцин и сывороток им. И.И. Мечникова РАМН, г. МоскваОтдел науки и медицины, Сталлержен, ФранцияMechnikov Research Institute for Vaccines and Sera of the Russian Academy of Medical SciencesDepartement Scientifique et Medical, Stallergenes S.A., Antony, France1504201182NO2 (2011)№2 (2011)687210032020Copyright ©; 2011, Pharmarus Print MediaCopyright ©; 2011, Фармарус Принт Медиа2011Pharmarus Print MediaФармарус Принт Медиаhttps://rusalljournal.ru/raj/article/view/803

The article deals with the problems of standardization of allergen vaccines for ASIT performing. At present time there are no uniform requirements, criteria and methods which allow to standardize these preparations. There upon information about preparation or cultivation of raw materials, about methods used for allergen vaccines biological activity evaluation, and about units for this activity expression is very important for choosing the preparation for ASIT. The information about major clinically significant allergens concentration is necessary because ASIT both effectiveness and safety depend on it. Phostal and Staloral are examples of these thoroughly characterized and standardized allergen vaccines.

Представлены современные проблемы стандартизации аллерговакцин, используемых для аллергенспецифической иммунотерапии (АСИТ). В настоящее время нет единых критериев и методов стандартизации этих препаратов. В этой связи при выборе препарата для АСИТ очень важной является информация о способах и условиях получения сырья для производства препарата, методах оценки его биологической активности и единицах ее измерения. Необходимой является информация о концентрации основных клинически значимых аллергенов, поскольку от этого зависят эффективность и безопасность АСИТ. Примерами таких всесторонне охарактеризованных и стандартизованных аллерговакцин являются Фосталь и Сталораль.

allergen vaccinesstandardizationreference preparationsаллерговакциныстандартизацияреференс-препаратыWHO Position Paper. Allergen immunotherapy: therapeutic vaccines for allergic diseases. Editors Bousquet J., Lockey R.F., Malling H.J. Allergy. 1998, v. 53, suppl. 44, 42 p.Esch R.E. Evaluation of allergen vaccine potency. Curr. Allergy Asthma Rep. 2006, v. 6, No. 5, p. 402-406.Slater J.E. Characterization of allergen extracts. Dev. Biol. 2005, v. 122, p. 145-152.Slater J.E. Standardized allergen vaccines in the United States. Clin. Allergy Immunol. 2008, v. 21, p. 273-281.Lorenz A.R., Lüttkopf D., Seitz R., Vieths S. The Regulatory System in Europe with Special Emphasis on Allergen Products. Int. Arch. Allergy Immunol. 2008, v. 147, p. 263-275.Petrova-Nikitina A.D., Antropova A.B., Mokeeva V.L. et al. To the study of biocenotic relationships between house dust mites (Acariformes: Pyroglyphidae) and mould fungi. Acarina. 2005, v. 13, No. 1, p. 75-84.Желтикова Т.М., Глушакова А.М., Алешо Н.А. Сообщество дрожжей, ассоциированных с желудочно-кишечным трактом рыжих тараканов Blattella germanica L. Мед. паразитология и паразитарные болезни. 2011, № 2, с. 75-84.Byzov B.A., Thanh V.N., Babjeva I.P. Interrelationships between yeasts and soil diplopods. Soil Biol. Biochem. 1993, v. 25, No. 8, p. 1119-1126.Batard T., Hrabina A., Bi X.Z. et al. Production and proteomic characterization of pharmaceutical-grade Dermatophagoides pteronyssinus and Dermatophagoides farinae extracts for allergy vaccines. Int. Arch. Allergy Immunol. 2006, v. 140, No. 4, p. 295-305.Dreborg S. Standardization of allergenic preparations by in vitro and in vivo methods. Allergy. 1993, v. 48, suppl. 14, p. 63-70.Tovey E.R., Baldo B.A. Standardization of allergens. Int. Archs. Allergy Appl. Immun. 1984, v. 75, p. 322-329.Larenas-Linnemann D., Cox L.S. European allergen extract units and potency: review of available information. Ann. Allergy Asthma Immunol. 2008, v. 100, No. 2, p. 137-145.Ford A., Seagroatt V., Platts-Mills T.A.E., Lowestein H. A collaborative study on the first international standard of Dermatophagoides pteronyssinus (house dust mite) extract. J. Allergy Clin. Immunol. 1985, v. 75, p. 676-686.Ree R. van. Indoor allergens: relevance of major allergen measurements and standardization. J. Allergy Clin. Immunol. 2007, v. 119, No. 2, p. 270-277.Platts-Mills T.A.E., Chapman M.D. Allergen standardization.J. Allergy Clin. Immunol. 1991, v. 87, No. 3, p. 621-625.American Academy of Allergy, Asthma and Immunology. Position statement. The use of standardized allergen extracts.J. Allergy Clin. Immunol. 1997, v. 99, No. 5, p. 583-586.Hrabina M., Dumur J.P., Sicard H. et al. Diagnosis of cypress pollen allergy: in vivo and in vitro standardization of a Juniperus ashei pollen extract. Allergy. 2003, v. 58, p. 808-813.Hrabina M., Purohit A., Oster J.P. et al. Standardization of an ash (Fraxinus excelsior) pollen allergen extract. Int. Arch. Allergy Immunol. 2007, v. 142, p. 11-18.Becker W.M., Vogel L., Vieths S. Standardization of allergen extracts for immunotherapy: where do we stand? Curr. Opin. Allergy Clin. Immunol. 2006, v. 6, No. 6, p. 470-475.Chapman M.D., Heymann P.W., Wilkins S.R. et al. Monoclonal immunoassays for major dust mite (Dermatophagoides) allergens, Der p I and Der f I, and quantitative analysis of the allergen content of mite and house dust extracts. J. Allergy Clin. Immunol. 1987, v. 80, p. 184-194.Ree R. van, Dorpema J.W., Vieths S. Allergy vaccines: a need for standardization in mass units of major allergen. Pharmeuropa Bio. 2005, No. 1, p. 27-30.Chapman M.D., Ferreira F., Villalba M. et al. CREATE consortium. The European Union CREATE project: a model for international standardization of allergy diagnostics and vaccines. J. Allergy Clin. Immunol. 2008, v. 122, No. 5, p. 882-889.Nelson H.S. The use of standardized extracts in allergen immunotherapy. J. Allergy Clin. Immunol. 2000, v. 106, No. 1, part 1, p. 41-45.Larsen J.N., Houghton C.G., Vega M.L., Lоwenstein H. Manufacturing and standardizing allergen extracts in Europe. Clin. Allergy Immunol. 2008, v. 21, p. 283-301.