title: 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.
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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  EudraCT no: 2011-004852-20; ClinicalTrials.gov Identifier: NCT01674595.
authors.affiliation: Hospital Universitario Reina Sofía, Córdoba, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Moreno
authors.affiliation: Complejo Hospitalario de Jaén, Jaén, Spain.
authors.forename: Blanca Sáenz
authors.initials: BS
authors.lastname: De San Pedro
authors.affiliation: Hospital de Jerez de la Frontera, Cádiz, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Millán
authors.affiliation: Servicio de Salud de Castilla La Mancha, Hospital Nuestra Señora del Prado, Talavera de la Reina, Toledo Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Panizo
authors.affiliation: Medical Department, ALK-Abelló S.A., C/ Miguel Fleta, 19, Madrid, 28037 Spain.
authors.forename: Santiago
authors.initials: S
authors.lastname: Martín
authors.affiliation: Hospital Universitario San Cecilio, Granada, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Florido
keywords: Allergen; Allergen-specific immunotherapy; Immune response; Olive pollen allergy; Seasonal allergic rhinitis; Skin reactivity; Tolerability