中文摘要：研究评估了一种过敏治疗疫苗的安全性，该疫苗由粉尘西波涅尘螨变应原和佐剂PL（脂蛋白体）构成。结果表明，以100 mu g 变应原/kg体重的剂量注射该疫苗不会导致明显的毒性作用。注射部位能够观察到局部反应，这主要归因于氢氧化铝的免疫原性。研究表明，临床上利用该疫苗治疗过敏反应是安全的。
 
外文摘要：The proteoliposome (PL) of Neisseria meningitidis serogroup B has been reported as a safe and potent vaccine adjuvant, inducing a T(H)1-skewed response. The present study describes a pre-clinical safety evaluation of an allergy therapeutic vaccine candidate based on purified allergens from Dermatophagoides siboney house dust mite and PL as adjuvant, both components adsorbed onto aluminum hydroxide gel. Two separate studies of acute toxicity evaluation were performed in mice and rabbits, and two repeat-dose studies were conducted in non-sensitized and allergen-sensitized Balb/c mice, respectively. The study in sensitized mice intends to model a therapeutic setting. Aerosolized allergen challenge was used in both settings to model natural respiratory exposure. In the therapeutic setting, mice were administered with three doses containing 2 mu g allergen at weekly intervals [subcutaneous route] and subsequently challenged with aerosolized allergen for 6 consecutive days. Parameters of general toxicity effects were assessed via measures of behavior, body weight, food and water consumption, and macroscopic evaluation of organs. Histological examination of organs and the injection site was performed. Potential immunotoxicity effects at the systemic level were assessed by blood eosinophil counting and serum allergen specific IgE by ELISA The vaccine did not produce general or functional toxic effects of significance, at a dose up to 100 mu g allergen per kg body weight. An expected local reaction at the injection site was observed, which could be attributed mostly to the immunological effect of aluminum hydroxide. The models implemented here suggest an acceptable safety profile of this vaccine for testing in clinical trials of allergy immunotherapy.
外文关键词：Dermatophagoides siboney； vaccine toxicity； passive cutaneous anaphylaxis； allergy vaccine
作者：Ramirez, W; Bourg, V; Torralba, D; Facenda, E; Tamargo, B; Gonzalez, BO; Sierra, G; Perez, O; Perez-Llano, Y; Labradaa, A
作者单位：Ctr Nacl Biopreparados of Cuba
期刊名称：JOURNAL OF IMMUNOTOXICOLOGY
期刊影响因子：2.021
出版年份：2017
出版刊次：7
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