Liposome‐entrapped D. pteronyssinus vaccination in mild asthma patients: effect of 1‐year double‐blind, placebo‐controlled trial on inflammation, bronchial hyper‐responsiveness and immediate and late bronchial responses to the allergen

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Abstract
Allergen vaccination is effective in mite-allergic asthma. Liposomes are immunological adjuvants that can act as allergen carriers. To evaluate the immunological and functional effects of a liposome-entrapped D. pteronyssinus vaccine on mite monosensitive, mild asthma patients. A double-blind, placebo-controlled trial was conducted on 26 asthma patients who randomly received vaccination or placebo for 1 year. The levels of exposure to Der p 1 allergen were constant during the study. Allergen bronchial challenge was made at the beginning (T0) and after 1 year of treatment (T12). The day before and 24 h after the allergen provocation, patients were challenged with methacholine (Mth) (until FEV1 fell by 40%) and blood and sputum samples were obtained. Dose-response curves to Mth were evaluated in terms of Mth-PD20 (dose of Mth that induced 20% drop in FEV1), slope (Mth-DRS) and level of plateau. Blood and sputum eosinophils and serum levels of eosinophil cationic protein (ECP) and intercellular adhesion molecule-1 (ICAM-1) were measured. Groups were comparable at the start of the trial. At TI2, previous to the allergen challenge, the active group showed higher values of both FEV1 and Mth-PD20 and lower values of Mth-DRS. The number of patients presenting a level of plateau increased in the active group (from two to four) and decreased in the placebo group (from two to one). At T12, before the allergen challenge, serum ECP levels increased in the placebo group and blood eosinophils showed a trend towards lower numbers in the active one. The immediate response and the changes in Mth-DRS values, sputum eosinophils and serum ECP levels following the allergen challenge were attenuated in the active group. Liposome-entrapped D. Pteronyssinus vaccination: (i) protects mild asthma patients from the worsening of asthma due to sustained mite exposure; and (ii) reduces the functional and inflammatory changes induced by allergen bronchial provocation.