RT Journal Article
T1 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.
A1 Moreno, Carmen
A1 Sáenz De San Pedro, Blanca
A1 Millán, Carmen
A1 Panizo, Carmen
A1 Martín, Santiago
A1 Florido, Fernando
K1 Allergen-specific immunotherapy
K1 Allergen
K1 Olive pollen allergy
K1 Immune response
K1 Skin reactivity
K1 Tolerability
K1 Seasonal allergic rhinitis
K1 Adulto
K1 Alérgenos
K1 Hidróxido de aluminio
K1 Asma
K1 Efectos colaterales y reacciones adversas relacionados con medicamentos
K1 Femenino
K1 Humanos
K1 Inmunoglobulina E
K1 Inmunoglobulina G
K1 Inmunoterapia
K1 Olea
K1 Polen
AB BACKGROUNDA 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.OBJECTIVETo 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 METHODSThe 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.RESULTSNinety-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.CONCLUSIONThis 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 REGISTRATIONEudraCT no: 2011-004852-20; ClinicalTrials.gov Identifier: NCT01674595.
PB BioMed Central
YR 2015
FD 2015-07-24
LK http://hdl.handle.net/10668/2558
UL http://hdl.handle.net/10668/2558
LA en
NO 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
NO Journal Article;
DS RISalud
RD Apr 4, 2025