JAPANESE SOCIETY OF ALLERGOLOGY TASK FORCE REPORT ON STANDARDIZATION OF HOUSE DUST MITE ALLERGEN VACCINES

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  • Takai Toshiro
    Atpoy (Allergy) Research Center, Juntendo University Graduate School of Medicine
  • Okamoto Yoshitaka
    Department of Otorhinolaryngology-Head and Neck Surgery, Graduate School of Medicine, Chiba University
  • Okubo Kimihiro
    Department of Head & Neck Sensory Organ Science (Otolaryngology), Graduate School, Nippon Medical School
  • Nagata Makoto
    Department of Respiratory Medicine, Saitama Medical University:Allergy Center, Saitama Medical University
  • Sakaguchi Masahiro
    Laboratory of Microbiology I, School of Veterinary Medicine, Azabu University
  • Fukutomi Yuma
    Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital
  • Saito Akemi
    Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital
  • Yasueda Hiroshi
    Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital
  • Masuyama Keisuke
    Department of Otorhinolaryngology-Head and Neck Surgery, Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi

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Other Title
  • ダニアレルゲンワクチン標準化に関する日本アレルギー学会タスクフォース報告
  • ダニアレルゲンワクチン ヒョウジュンカ ニ カンスル ニホン アレルギー ガッカイ タスクフォース ホウコク

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Background: In the 1990s, the Japanese Society of Allergology (JSA) standardized Japanese cedar pollen allergen vaccines. In the present study, the task force for house dust mite (HDM) allergen standardization of the Committee for Allergens and Immunotherapy of JSA reports the standardization of HDM allergen vaccines in Japan. Methods: In vivo allergenic potency was determined by intradermal testing of 51 Japanese adults with positive serum specific IgE to HDM allergens. In vitro total IgE binding potency was analyzed by the competitive ELISA using a pooled serum, with sera obtained from 10 allergic patients. Concentrations of HDM group 1 (Der 1) and group 2 major allergens in eight HDM allergen extracts were measured by sandwich ELISAs. Correlation between the in vitro total IgE binding potency and major allergen levels was analyzed. Results: We selected a JSA reference HDM extract and determined its in vivo allergenic potency. The in vitro total IgE binding potency significantly correlated with Der 1 content, group 2 allergen content, and their combined amount, indicating that measurement of major allergen contents can be used as a surrogate in vitro assay. Conclusions: The task force determined the in vivo allergenic potency (100000JAU/ml) and Der 1 content (38.5μg/ml) of the JSA reference HDM extract, selected the measurement of Der 1 content as the surrogate in vitro assay, and decided that manufacturers can label a HDM allergen extract as having a titer of 100000JAU/ml if it contains 22.2-66.7μg/ml of Der 1.

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