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Clinical and Translational Allergy

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Open Access 01-12-2015 | Research

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

Authors: Carmen Moreno, Blanca Sáenz De San Pedro, Carmen Millán, Carmen Panizo, Santiago Martín, Fernando Florido

Published in: Clinical and Translational Allergy | Issue 1/2015

Abstract

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 IgG₄ 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. IgG₄ 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 IgG₄ 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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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
Authors: Carmen Moreno
Blanca Sáenz De San Pedro
Carmen Millán
Carmen Panizo
Santiago Martín
Fernando Florido
Publication date: 01-12-2015
Publisher: BioMed Central
Published in: Clinical and Translational Allergy / Issue 1/2015
Electronic ISSN: 2045-7022
DOI: https://doi.org/10.1186/s13601-015-0070-y

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Objective

Material and methods

Results

Conclusion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Objective

Material and methods

Results

Conclusion

Trial registration

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