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lüll Efficacy and safety of preseasonal-specific immunotherapy with an aluminium-adsorbed six-grass pollen allergoid Corrigan CJ; Kettner J; Doemer C; Cromwell O; Narkus AAllergy 2005[Jun]; 60 (6): 801-7BACKGROUND: The clinical efficacy and safety of a six-grass pollen allergoid has been studied. The advent of more exacting clinical guidelines and a better appreciation of the possible mechanisms of treatment prompted this reappraisal. METHODS: A 2-year double-blind multicentre placebo-controlled phase 3 clinical trial was undertaken in 154 patients suffering symptoms of rhinoconjunctivitis with or without asthma (GINA I or II). Therapy comprised two consecutive preseasonal short-courses of subcutaneous injections using a grass pollen allergoid adsorbed to aluminium hydroxide. RESULTS: A combined symptom and medication score (SMS) was used as the primary end-point for clinical efficacy. SMS from the first year showed a significant difference of 26.6% between the two study groups (P=0.026) and this was improved after the second year when there was a 48.4% difference in SMS between active and placebo treatment in favour of the allergoid (P = 0.018). Highly significant increases in grass pollen allergen-specific IgG1 and IgG4 antibody concentrations were measured in association with active treatment. Allergen tolerance was increased as judged by a conjunctival provocation test and significant improvements in quality of life were documented using a standardized questionnaire. The allergoid was well tolerated. CONCLUSIONS: The grass pollen allergoid was shown to be safe and clinically efficacious in the management of hay fever with or without asthma (GINA I or II).|*Poaceae/immunology[MESH]|*Pollen/immunology[MESH]|Adolescent[MESH]|Adult[MESH]|Allergens/administration & dosage/immunology/*therapeutic use[MESH]|Allergoids[MESH]|Antibody Specificity[MESH]|Asthma/complications/therapy[MESH]|Conjunctivitis/blood/complications/*therapy[MESH]|Double-Blind Method[MESH]|Female[MESH]|Germany[MESH]|Humans[MESH]|Immunoglobulin E/blood[MESH]|Immunoglobulin G/blood[MESH]|Injections, Subcutaneous[MESH]|Male[MESH]|Middle Aged[MESH]|Plant Extracts/administration & dosage/*therapeutic use[MESH]|Quality of Life[MESH]|Rhinitis, Allergic, Seasonal/blood/*therapy[MESH]|United Kingdom[MESH]|Vaccines[MESH]|Vaccines, Synthetic/administration & dosage/*therapeutic use[MESH] |