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

Clinical and Translational Allergy

Fernando Florido⁶  Santiago Martín⁵  Carmen Panizo⁴  Carmen Millán²  Blanca Sáenz De San Pedro¹  Carmen Moreno³ 

[1] Complejo Hospitalario de Jaén, Jaén, Spain;Hospital de Jerez de la Frontera, Cádiz, Spain;Hospital Universitario Reina Sofía, Córdoba, Spain;Servicio de Salud de Castilla La Mancha, Hospital Nuestra Señora del Prado, Talavera de la Reina, Toledo, Spain;Medical Department, ALK-Abelló S.A., C/ Miguel Fleta, 19, Madrid 28037, Spain;Hospital Universitario San Cecilio, Granada, Spain

关键词: Seasonal allergic rhinitis;    Tolerability;    Skin reactivity;    Immune response;    Olive pollen allergy;    Allergen;    Allergen-specific immunotherapy;   

Others  :  1220856
DOI  :  10.1186/s13601-015-0070-y

 received in 2015-04-13, accepted in 2015-06-16,  发布年份 2015

【 摘 要 】

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 ₄and 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 ₄and 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 ₄and 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.

【 授权许可】

   
2015 Moreno et al.

【 图 表 】

Fig. 1.

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