Please use this identifier to cite or link to this item: http://hdl.handle.net/10668/2558
Título : 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.
Autor : Moreno, Carmen
Sáenz De San Pedro, Blanca
Millán, Carmen
Panizo, Carmen
Martín, Santiago
Florido, Fernando
Filiación: [Moreno,C]Hospital Universitario Reina Sofía, Cordoba, Spain. [Sáenz De San Pedro,B]Complejo Hospitalario de Jaén, Jaén, Spain. [Millán,C] Hospital de Jerez de la Frontera, Cádiz, Spain. [Panizo,C] Servicio de Salud de Castilla La Mancha, Hospital Nuestra Señora del Prado, Talavera de la Reina, Toledo, Spain. [Martín,S] Medical Department, ALK-Abelló S.A., Madrid, Spain. [Florido,F] Hospital Universitario San Cecilio, Granada, Spain.
Palabras clave : Allergen-specific immunotherapy
Allergen
Olive pollen allergy
Immune response
Skin reactivity
Tolerability
Seasonal allergic rhinitis
Adulto
Alérgenos
Hidróxido de aluminio
Asma
Efectos colaterales y reacciones adversas relacionados con medicamentos
Femenino
Humanos
Inmunoglobulina E
Inmunoglobulina G
Inmunoterapia
Olea
Polen
MeSH: Medical Subject Headings::Named Groups::Persons::Age Groups::Adult
Medical Subject Headings::Chemicals and Drugs::Biological Factors::Antigens::Allergens
Medical Subject Headings::Chemicals and Drugs::Inorganic Chemicals::Aluminum Compounds::Aluminum Hydroxide
Medical Subject Headings::Diseases::Respiratory Tract Diseases::Bronchial Diseases::Asthma
Medical Subject Headings::Check Tags::Female
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Immunoglobulin Isotypes::Immunoglobulin E
Medical Subject Headings::Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Immunoglobulin Isotypes::Immunoglobulin G
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Biological Therapy::Immunomodulation::Immunotherapy
Medical Subject Headings::Organisms::Eukaryota::Plants::Viridiplantae::Streptophyta::Embryophyta::Angiosperms::Oleaceae::Olea
Medical Subject Headings::Anatomy::Plant Structures::Plant Components, Aerial::Flowering Tops::Flowers::Germ Cells, Plant::Pollen
Medical Subject Headings::Diseases::Substance-Related Disorders::Drug-Related Side Effects and Adverse Reactions
Fecha de publicación : 24-Jul-2015
Editorial : BioMed Central
Cita Bibliográfica: Moreno C, De San Pedro BS, Millán C, Panizo C, Martín S, Florido F. 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. Clin Transl Allergy. 2015; 5:27
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.
Descripción : Journal Article;
URI: http://hdl.handle.net/10668/2558
Versión del editor : https://ctajournal.biomedcentral.com/articles/10.1186/s13601-015-0070-y#Abs1
DOI: 10.1186/s13601-015-0070-y
ISSN : 2045-7022 (Online)
Appears in Collections:01- Artículos - Complejo Hospitalario de Jaén
01- Artículos - Hospital Reina Sofía
01- Artículos - Hospital de Jerez
01- Artículos - Complejo Hospitalario Universitario de Granada

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