title: Safety and tolerability of immunotherapy using various updosing schedules of a new SCIT product with an optimised allergen/aluminium hydroxide ratio.
abstract: Allergen extracts for subcutaneous specific immunotherapy (SCIT) may be adsorbed to aluminium hydroxide for adjuvant effect and to delay allergen discharge. A product with an optimised allergen-to-aluminium hydroxide ratio enables a lower allergen dose and shorter introduction phase. The new therapeutic product Avanz (ALK, Denmark) has an optimised allergen-to-aluminium hydroxide ratio. A multicentre, randomised, phase II clinical trial evaluated the immunological effects and tolerability of two different five-step updosing schedules for Avanz in 400 patients with grass pollen-induced rhinoconjunctivitis with or without asthma, randomised into two groups. Group 1 were administered weekly, and group 2 were administered every 3 to 4 days. After updosing, patients received two maintenance injections after 2 and 4 weeks. In the updosing phase, local and systemic reactions were significantly more frequent in group 2 than group 1. In the maintenance phase, adverse reactions were less common in both groups. No generalised reactions with hypotension or fatal reactions occurred. An increase in allergen-specific immunoglobulin G(4) (IgG(4) ) and IgE antibodies was established one week after the last injection. Avanz is a SCIT product with an optimised allergen-to-aluminium hydroxide ratio that enables a shorter updosing phase. We established an improved safety profile with weekly updosing compared with 3-4-day intervals. Clinical trials are needed to confirm clinical efficacy.
authors.affiliation: Dermatologist and Immunologist, Clinic of Dermatology, Erfurt, Germany. kirsten_junge@t-online.de
authors.forename: K
authors.initials: K
authors.lastname: Jung
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects; D000485:Allergens / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D000536:Aluminum Hydroxide / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D000818:Animals; D002986:Clinical Trials as Topic; D003888:Desensitization, Immunologic / Q000592:standards; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood / Q000276:immunology; D007074:Immunoglobulin G / Q000097:blood / Q000276:immunology; D007279:Injections, Subcutaneous; D051379:Mice; D006109:Poaceae / Q000276:immunology; D011058:Pollen / Q000276:immunology*; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D000485:Allergens; D007074:Immunoglobulin G; D007073:Immunoglobulin E; D000536:Aluminum Hydroxide