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Recombinant hypoallergenic derivative is the next generation of tolerogen replacing the natural allergen extract to increase safety and efficacy. Japanese cedar pollinosis is the predominant seasonal allergy disease in Japan. A rice seed-based oral vaccine containing the recombinant hypoallergens derived from these allergens was developed. Efficacy of this rice-based allergy vaccine was evaluated by oral administration in animal models.

Background: The anti-inflammatory potential of antihistamines has significant clinical utility. Long-term pharmacotherapy of so-called 'safe' antihistamines may be hampered by side effects in the central nervous system. In the present study, the new potential antihistamine SUN-1334H was compared with different antihistamines for anti-inflammatory effects, sedation potential and interaction with alcohol., Method: Nasal and skin allergy were induced in guinea pig and mice by ovalbumin sensitization and challenge. Neurogenic nasal inflammation was induced by capsaicin. Sedation potential and interaction with alcohol were assessed by i.v. and intracerebroventricular pentobarbital-induced sedation and alcohol-induced ataxia models., Results: Ovalbumin sensitization and challenge caused rhinitis pathology including inflammatory cell infiltration, IL-4, and protein leakage in the nasal lavage fluid (NLF) and presence of inflammatory cells in nasal epithelium. A 5-day treatment of antihistamines reduced these markers of inflammation. SUN-1334H, cetirizine and hydroxyzine caused comparable inhibition of NLF leukocytes, IL-4 and total protein concentrations. Fexofenadine and desloratadine showed moderate inhibition of NLF leukocytes and had no significant effect on IL-4 concentration. While fexofenadine had no effect on total protein concentration, the effect of desloratadine was comparable with the other antihistamines. In neurogenic nasal inflammation induced by capsaicin, SUN-1334H and fexofenadine caused better inhibition at lower and middle dose levels than the other antihistamines. In skin allergy models, SUN-1334H showed potent reduction of passive and active cutaneous anaphylactic reactions. In central nervous system side effects models, SUN-1334H, desloratadine and fexofenadine were devoid of any significant effects., Conclusions: The results are suggestive of a high anti-inflammatory to sedation index of SUN-1334H among leading antihistamines.

The aim of this study was to explore complement activation in the nasal lavage following a nasal ragweed-allergen challenge. The study was carried out with 15 adolescents who were allergic to ragweed and with six non-allergic healthy volunteers. Following the baseline measurement after the symptoms were registered, subjects were given increasing doses of ragweed allergen. Lavage fluid was collected and tested for a complement-activation product (C3bBbP). The allergic patients responded to allergen provocation with an increase in C3bBbP formation compared to the initial lavage (p = 0.001). The C3bBbP level remained low in the lavage fluids of the non-allergic controls. We found a strong correlation between the threshold dose that induced symptoms and the dose where the maximum complement activation was detected (r = 0.78, p = 0.001). Our findings indicate that in allergic patients nasal challenge with ragweed allergen induces a rise in complement activation in the nasal lavage fluid. These results highlight the role of the complement system in the allergic inflammation on the nasal mucosal surface.