脑膜炎奈瑟菌蛋白脂质体作为屋尘螨过敏疫苗佐剂的安全性。

IF 2.4 4区 医学 Q3 TOXICOLOGY Journal of Immunotoxicology Pub Date : 2017-12-01 DOI:10.1080/1547691X.2017.1346007
Wendy Ramírez, Virgilio Bourg, Damaris Torralba, Elisa Facenda, Beatriz Tamargo, Bárbara O González, Gustavo Sierra, Oliver Pérez, Yordanis Perez-Llano, Alexis Labrada
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引用次数: 4

摘要

据报道,脑膜炎奈瑟菌血清B组的蛋白脂体(PL)是一种安全有效的疫苗佐剂,可诱导th1偏斜反应。本研究描述了一种过敏治疗性候选疫苗的临床前安全性评估,该疫苗基于纯化的siboney家尘螨过敏原和PL作为佐剂,这两种成分都吸附在氢氧化铝凝胶上。分别在小鼠和家兔身上进行了两项单独的急性毒性评价研究,并在未致敏和过敏原致敏的Balb/c小鼠身上进行了两项重复给药研究。在致敏小鼠中进行的研究旨在模拟治疗环境。在这两种情况下,雾化过敏原挑战都被用来模拟自然呼吸暴露。在治疗组中,小鼠每隔一周皮下注射三次含2 μg过敏原的剂量,随后连续6天雾化过敏原。一般毒性作用的参数通过行为、体重、食物和水的消耗以及器官的宏观评价来评估。对器官及注射部位进行组织学检查。采用ELISA法测定血嗜酸性粒细胞计数和血清过敏原特异性IgE,评估疫苗在全身水平上的潜在免疫毒性作用。当剂量高达每公斤体重100 μg过敏原时,疫苗没有产生显著的一般或功能性毒性作用。在注射部位观察到预期的局部反应,这主要归因于氢氧化铝的免疫作用。本文采用的模型表明,该疫苗在过敏免疫治疗的临床试验中具有可接受的安全性。
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Safety of a proteoliposome from Neisseria meningitides as adjuvant for a house dust mite allergy vaccine.

The proteoliposome (PL) of Neisseria meningitidis serogroup B has been reported as a safe and potent vaccine adjuvant, inducing a TH1-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 μg 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 μg 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.

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来源期刊
Journal of Immunotoxicology
Journal of Immunotoxicology 医学-毒理学
CiteScore
6.70
自引率
3.00%
发文量
26
审稿时长
1 months
期刊介绍: The Journal of Immunotoxicology is an open access, peer-reviewed journal that provides a needed singular forum for the international community of immunotoxicologists, immunologists, and toxicologists working in academia, government, consulting, and industry to both publish their original research and be made aware of the research findings of their colleagues in a timely manner. Research from many subdisciplines are presented in the journal, including the areas of molecular, developmental, pulmonary, regulatory, nutritional, mechanistic, wildlife, and environmental immunotoxicology, immunology, and toxicology. Original research articles as well as timely comprehensive reviews are published.
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