Please use this identifier to cite or link to this item: http://hdl.handle.net/10668/2558
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dc.contributor.authorMoreno, Carmen-
dc.contributor.authorSáenz De San Pedro, Blanca-
dc.contributor.authorMillán, Carmen-
dc.contributor.authorPanizo, Carmen-
dc.contributor.authorMartín, Santiago-
dc.contributor.authorFlorido, Fernando-
dc.date.accessioned2016-12-05T12:28:36Z-
dc.date.available2016-12-05T12:28:36Z-
dc.date.issued2015-07-24-
dc.identifier.citationMoreno 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; 5:27es
dc.identifier.issn2045-7022 (Online)-
dc.identifier.otherPMC4513679-
dc.identifier.urihttp://hdl.handle.net/10668/2558-
dc.descriptionJournal Article;es
dc.description.abstractBACKGROUND 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.es
dc.language.isoenes
dc.publisherBioMed Centrales
dc.relation.ispartofClinical and Translational Allergyes
dc.subjectAllergen-specific immunotherapyes
dc.subjectAllergenes
dc.subjectOlive pollen allergyes
dc.subjectImmune responsees
dc.subjectSkin reactivityes
dc.subjectTolerabilityes
dc.subjectSeasonal allergic rhinitises
dc.subjectAdultoes
dc.subjectAlérgenoses
dc.subjectHidróxido de aluminioes
dc.subjectAsmaes
dc.subjectEfectos colaterales y reacciones adversas relacionados con medicamentoses
dc.subjectFemeninoes
dc.subjectHumanoses
dc.subjectInmunoglobulina Ees
dc.subjectInmunoglobulina Ges
dc.subjectInmunoterapiaes
dc.subjectOleaes
dc.subjectPolenes
dc.subject.meshMedical Subject Headings::Named Groups::Persons::Age Groups::Adultes
dc.subject.meshMedical Subject Headings::Chemicals and Drugs::Biological Factors::Antigens::Allergenses
dc.subject.meshMedical Subject Headings::Chemicals and Drugs::Inorganic Chemicals::Aluminum Compounds::Aluminum Hydroxidees
dc.subject.meshMedical Subject Headings::Diseases::Respiratory Tract Diseases::Bronchial Diseases::Asthmaes
dc.subject.meshMedical Subject Headings::Check Tags::Femalees
dc.subject.meshMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humanses
dc.subject.meshMedical Subject Headings::Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Immunoglobulin Isotypes::Immunoglobulin Ees
dc.subject.meshMedical Subject Headings::Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Immunoglobulin Isotypes::Immunoglobulin Ges
dc.subject.meshMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Biological Therapy::Immunomodulation::Immunotherapyes
dc.subject.meshMedical Subject Headings::Organisms::Eukaryota::Plants::Viridiplantae::Streptophyta::Embryophyta::Angiosperms::Oleaceae::Oleaes
dc.subject.meshMedical Subject Headings::Anatomy::Plant Structures::Plant Components, Aerial::Flowering Tops::Flowers::Germ Cells, Plant::Pollenes
dc.subject.meshMedical Subject Headings::Diseases::Substance-Related Disorders::Drug-Related Side Effects and Adverse Reactionses
dc.titleExploratory study of tolerability and immunological effect of a short up-dosing immunotherapy phase with a standardised allergen extract derived from pollen of Olea europaea.es
dc.typeinfo:eu-repo/semantics/articlees
dc.description.versionYeses
dc.identifier.pmid26213608-
dc.rights.accessRightsAcceso abiertoes
dc.identifier.doi10.1186/s13601-015-0070-y-
dc.type.versioninfo:eu-repo/semantics/publishedes
dc.relation.publisherversionhttps://ctajournal.biomedcentral.com/articles/10.1186/s13601-015-0070-y#Abs1es
dc.contributor.authoraffiliation[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.es
dc.type.subtypeArtículoes
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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