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Exploratory study of tolerability and immunological effect of a short up-dosing immunotherapy phase with a standardised allergen extract derived from pollen of Olea europaea

BACKGROUND: A new subcutaneous specific immunotherapy (SCIT) product adsorbed on aluminium hydroxide has been developed with a short and simplified up-dosing phase, containing a biologically standardized allergen pollen extract from Olea europaea. OBJECTIVE: To assess the tolerability profile of the...

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Autores principales: Moreno, Carmen, De San Pedro, Blanca Sáenz, Millán, Carmen, Panizo, Carmen, Martín, Santiago, Florido, Fernando
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4513679/
https://www.ncbi.nlm.nih.gov/pubmed/26213608
http://dx.doi.org/10.1186/s13601-015-0070-y
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author Moreno, Carmen
De San Pedro, Blanca Sáenz
Millán, Carmen
Panizo, Carmen
Martín, Santiago
Florido, Fernando
author_facet Moreno, Carmen
De San Pedro, Blanca Sáenz
Millán, Carmen
Panizo, Carmen
Martín, Santiago
Florido, Fernando
author_sort Moreno, Carmen
collection PubMed
description BACKGROUND: A new subcutaneous specific immunotherapy (SCIT) product adsorbed on aluminium hydroxide has been developed with a short and simplified up-dosing phase, containing a biologically standardized allergen pollen extract from Olea europaea. OBJECTIVE: To assess the tolerability profile of the updosing phase and its immunological effect, in terms of specific IgG(4) and IgE levels and immediate skin reactivity. MATERIAL AND METHODS: The study was an exploratory, multi-centre, open-label, single-arm, phase II/III clinical trial. Adults with a clinical history of allergic rhinoconjunctivitis with/without asthma due to sensitization to olive pollen were selected. Five up-dosing doses (300, 600, 3000, 6000 and 15000SQ+) were administered at weekly intervals, followed by a maintenance dose (15000SQ+) after 2 weeks. Adverse events were collected during the 30 min observation period after injections, after a telephone contact 2 days after each visit, and after reviewing the subjects’ diary. IgG(4) and IgE levels and immediate skin reactivity were evaluated at the beginning and at the end of the trial. RESULTS: Ninety-three subjects were included in the trial (mean age, 35.7 ± 10.3 years; women, 66.7 %). A total of 95 adverse drug reactions, all mild in intensity and non-serious, were reported during the trial: 85 local in 34.4 % subjects, 9 systemic in 4.3 % subjects and one non-specific (grade 0). Within 6 weeks, significant changes in IgG(4) and IgE levels and in immediate skin reactivity to Olea europaea were accomplished. CONCLUSION: This new SCIT derived from pollen of Olea europaea presented a good tolerability profile and induced significant immunological responses already after a 6 week treatment. However, the non-controlled design may limit the interpretation of these results. TRIAL REGISTRATION: EudraCT no: 2011-004852-20; ClinicalTrials.gov Identifier: NCT01674595.
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spelling pubmed-45136792015-07-25 Exploratory study of tolerability and immunological effect of a short up-dosing immunotherapy phase with a standardised allergen extract derived from pollen of Olea europaea Moreno, Carmen De San Pedro, Blanca Sáenz Millán, Carmen Panizo, Carmen Martín, Santiago Florido, Fernando Clin Transl Allergy Research BACKGROUND: A new subcutaneous specific immunotherapy (SCIT) product adsorbed on aluminium hydroxide has been developed with a short and simplified up-dosing phase, containing a biologically standardized allergen pollen extract from Olea europaea. OBJECTIVE: To assess the tolerability profile of the updosing phase and its immunological effect, in terms of specific IgG(4) and IgE levels and immediate skin reactivity. MATERIAL AND METHODS: The study was an exploratory, multi-centre, open-label, single-arm, phase II/III clinical trial. Adults with a clinical history of allergic rhinoconjunctivitis with/without asthma due to sensitization to olive pollen were selected. Five up-dosing doses (300, 600, 3000, 6000 and 15000SQ+) were administered at weekly intervals, followed by a maintenance dose (15000SQ+) after 2 weeks. Adverse events were collected during the 30 min observation period after injections, after a telephone contact 2 days after each visit, and after reviewing the subjects’ diary. IgG(4) and IgE levels and immediate skin reactivity were evaluated at the beginning and at the end of the trial. RESULTS: Ninety-three subjects were included in the trial (mean age, 35.7 ± 10.3 years; women, 66.7 %). A total of 95 adverse drug reactions, all mild in intensity and non-serious, were reported during the trial: 85 local in 34.4 % subjects, 9 systemic in 4.3 % subjects and one non-specific (grade 0). Within 6 weeks, significant changes in IgG(4) and IgE levels and in immediate skin reactivity to Olea europaea were accomplished. CONCLUSION: This new SCIT derived from pollen of Olea europaea presented a good tolerability profile and induced significant immunological responses already after a 6 week treatment. However, the non-controlled design may limit the interpretation of these results. TRIAL REGISTRATION: EudraCT no: 2011-004852-20; ClinicalTrials.gov Identifier: NCT01674595. BioMed Central 2015-07-24 /pmc/articles/PMC4513679/ /pubmed/26213608 http://dx.doi.org/10.1186/s13601-015-0070-y Text en © Moreno et al. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Moreno, Carmen
De San Pedro, Blanca Sáenz
Millán, Carmen
Panizo, Carmen
Martín, Santiago
Florido, Fernando
Exploratory study of tolerability and immunological effect of a short up-dosing immunotherapy phase with a standardised allergen extract derived from pollen of Olea europaea
title Exploratory study of tolerability and immunological effect of a short up-dosing immunotherapy phase with a standardised allergen extract derived from pollen of Olea europaea
title_full Exploratory study of tolerability and immunological effect of a short up-dosing immunotherapy phase with a standardised allergen extract derived from pollen of Olea europaea
title_fullStr Exploratory study of tolerability and immunological effect of a short up-dosing immunotherapy phase with a standardised allergen extract derived from pollen of Olea europaea
title_full_unstemmed Exploratory study of tolerability and immunological effect of a short up-dosing immunotherapy phase with a standardised allergen extract derived from pollen of Olea europaea
title_short Exploratory study of tolerability and immunological effect of a short up-dosing immunotherapy phase with a standardised allergen extract derived from pollen of Olea europaea
title_sort exploratory study of tolerability and immunological effect of a short up-dosing immunotherapy phase with a standardised allergen extract derived from pollen of olea europaea
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4513679/
https://www.ncbi.nlm.nih.gov/pubmed/26213608
http://dx.doi.org/10.1186/s13601-015-0070-y
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