Japanese Society of Allergology task force report on standardization of house dust mite allergen vaccines – Secondary publication

Abstract

The task force determined the in vivo allergenic potency (100,000 JAU/ml) and Der 1 content (38.5 μg/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 100,000 JAU/ml if it contains 22.2-66.7 μg/ml of Der 1.

Bioavailability of House Dust Mite Allergens in Sublingual Allergy Tablets Is Highly Dependent on the Formulation

“…The in vivo allergen potency of the Japanese reference HDM allergen extract was established via intradermal testing. Because of the observed correlation between in vitro IgE reactivity and the concentration of HDM major allergens, tablet strengths were subsequently assigned based on the group 1 HDM allergen contents of tablet drug substances using a JSA-developed Der 1 ELISA as a surrogate in vitro assay [23]. The drug substance HDM allergen content can be used as a representative measure of product strength for SLIT tablets of identical formulations and identical extract compositions, but it cannot be used to compare the actual, effective strengths of SLIT tablets that differ with regard to allergen composition, disintegration, and dissolution properties.…”

“…These are proprietary units based on the manufacturers' in-house references and assays and are therefore not comparable. Recently, however, independently of the 2 manufacturers, the Japanese Society of Allergology (JSA) assigned nominal strengths in Japanese allergen units (JAU) to the HDM SLIT tablets, with the Japanese HDM standard as the common reference [23]. Consequently, the nominal strengths of the tablets will be referred to as follows: ACZX (12 SQ-HDM/20,000 JAU), MTC (6 SQ-HDM/10,000 JAU), ACT (300 IR/57,000 JAU), and ACT (100 IR/19,000 JAU).…”

Regulation of upper airway inflammation facilitates comfortable breathing

“…9 Standardizing allergen vaccines/extracts is necessary for diagnosis and therapy. Whereas JCP allergen vaccines have been standardized in Japan since the 1990s, this had not yet been done for HDM allergen vaccines.…”

Efficacy and safety of the SQ house dust mite sublingual immunotherapy tablet in Japanese adults and adolescents with house dust mite–induced allergic rhinitis

“…The Japanese Society of Allergology Task Force standardized the HDM AIT vaccine in 2014. 18 To standardize the SQ HDM SLIT tablet, allergen contents of the standardized HDM AIT vaccine were first measured by using the manufacturer's methods to calculate the correction value. As a result of the adjustment by correction value and titer of the standardized HDM AIT vaccine, a nominal strength of 3,300 Japanese Allergy Unit (JAU) has the same potency as 2 SQ-HDM, 10,000 JAU as 6 SQ-HDM, and 20,000 JAU as 12 SQ-HDM.…”