Safety of a proteoliposome from Neisseria meningitides as adjuvant for a house dust mite allergy vaccine

Autor: Wendy Ramírez, Virgilio Bourg, Damaris Torralba, Elisa Facenda, Beatriz Tamargo, Bárbara O. González, Gustavo Sierra, Oliver Pérez, Yordanis Perez-Llano, Alexis Labrada
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Zdroj: Journal of Immunotoxicology, Vol 14, Iss 1, Pp 152-159 (2017)
Druh dokumentu: article
ISSN: 1547-691X
1547-6901
1547691X
DOI: 10.1080/1547691X.2017.1346007
Popis: 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.
Databáze: Directory of Open Access Journals
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