Moreno, CarmenSáenz De San Pedro, BlancaMillán, CarmenPanizo, CarmenMartín, SantiagoFlorido, Fernando2016-12-052016-12-052015-07-24Moreno 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; 5:27http://hdl.handle.net/10668/2558Journal Article;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.enAllergen-specific immunotherapyAllergenOlive pollen allergyImmune responseSkin reactivityTolerabilitySeasonal allergic rhinitisAdultoAlérgenosHidróxido de aluminioAsmaEfectos colaterales y reacciones adversas relacionados con medicamentosFemeninoHumanosInmunoglobulina EInmunoglobulina GInmunoterapiaOleaPolenMedical Subject Headings::Named Groups::Persons::Age Groups::AdultMedical Subject Headings::Chemicals and Drugs::Biological Factors::Antigens::AllergensMedical Subject Headings::Chemicals and Drugs::Inorganic Chemicals::Aluminum Compounds::Aluminum HydroxideMedical Subject Headings::Diseases::Respiratory Tract Diseases::Bronchial Diseases::AsthmaMedical Subject Headings::Check Tags::FemaleMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Immunoglobulin Isotypes::Immunoglobulin EMedical Subject Headings::Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Immunoglobulin Isotypes::Immunoglobulin GMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Biological Therapy::Immunomodulation::ImmunotherapyMedical Subject Headings::Organisms::Eukaryota::Plants::Viridiplantae::Streptophyta::Embryophyta::Angiosperms::Oleaceae::OleaMedical Subject Headings::Anatomy::Plant Structures::Plant Components, Aerial::Flowering Tops::Flowers::Germ Cells, Plant::PollenMedical Subject Headings::Diseases::Substance-Related Disorders::Drug-Related Side Effects and Adverse Reactionsresearch article26213608open access10.1186/s13601-015-0070-y2045-7022PMC4513679