title: Timothy grass pollen therapeutic vaccine: optimal dose for subcutaneous immunotherapy.
abstract: OBJECTIVE
  To establish the optimal dose of Phleum pratense subcutaneous immunotherapy (SCIT) in patients with allergic rhinoconjunctivitis with/without asthma.
  
  
  METHODS
  One hundred and fifty-one patients were randomized to receive SCIT 0.25, 0.5, 1.0, 2.0 or 4.0 skin-prick test units (SPT) or placebo. The primary end point was the variation in the concentration of Phleum pratense extract needed to produce a positive nasal provocation test from baseline (V0) to final visit (FV).
  
  
  RESULTS
  After 17 weeks, a dose-dependent trend was apparent in the concentration of P. pratense extract needed to produce a positive nasal provocation response. Systemic adverse reactions occurred with 3.2% of administered doses. Grade III (n = 2) and IV (n = 2) events were observed only at the two highest doses.
  
  
  CONCLUSIONS
  P. pratense depot SCIT showed signs of clinical and immunological efficacy by dose-dependently decreasing the allergen sensitization rate. Risk-benefit favored doses below 1.0 SPT units for confirmatory trials.
authors.affiliation: Allergy Service, Hospital Universitario Ramón y Cajal, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Sola
authors.affiliation: Imuno-Allergology Department, Centro Hospitalar Vila Nova de Gaia/Espinho, Portugal.
authors.forename: José Alberto
authors.initials: JA
authors.lastname: da Silva Ferreira
authors.affiliation: Allergy Service, Hospital Puerta de Hierro Majadahonda, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Dionicio Elera
authors.affiliation: Imuno-Allergology Service, Centro Hospitalar de S. João, Porto, Portugal.
authors.forename: José Luís
authors.initials: JL
authors.lastname: Plácido
authors.affiliation: Imuno-Allergology Service, Hospital da Universidade de Coimbra, Portugal.
authors.forename: Celso
authors.initials: C
authors.lastname: Pereira
authors.affiliation: Imuno-Allergology Service, CUF Porto Instituto e Hospital, Universidade do Porto, Portugal.
authors.forename: João
authors.initials: J
authors.lastname: Fonseca
authors.affiliation: Allergy Service, Hospital Nuestra Señora del Prado, Talavera de la Reina, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Panizo
authors.affiliation: Imuno-Allergology Service, Centro Hospitalar de Setúbal, Portugal.
authors.forename: Luís Filipe
authors.initials: LF
authors.lastname: Inácio
authors.affiliation: Department of Allergy, Hospital Universitario La Paz, Madrid, Spain.
authors.forename: Nataly
authors.initials: N
authors.lastname: Cancelleire
authors.affiliation: Allergy Service, Hospital General Universitario Gregorio Marañón, Madrid, Spain CIBERER (U-761).
authors.forename: José Manuel
authors.initials: JM
authors.lastname: Zubeldia Ortuño
authors.affiliation: Bial Industrial Farmacéutica S.A., Zamudio, Spain.
authors.forename: Araitz
authors.initials: A
authors.lastname: Landeta
authors.affiliation: Bial Industrial Farmacéutica S.A., Zamudio, Spain.
authors.forename: Begoña
authors.initials: B
authors.lastname: Madariaga
authors.affiliation: Bial Industrial Farmacéutica S.A., Zamudio, Spain.
authors.forename: Alberto
authors.initials: A
authors.lastname: Martínez
mesh_terms: D000328:Adult; D000485:Allergens / Q000008:administration & dosage* / Q000009:adverse effects; D052179:Antigens, Plant / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000150:complications / Q000276:immunology / Q000628:therapy*; D003233:Conjunctivitis, Allergic / Q000150:complications / Q000276:immunology / Q000628:therapy*; D003888:Desensitization, Immunologic; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009299:Nasal Provocation Tests; D031784:Phleum / Q000276:immunology*; D011058:Pollen / Q000276:immunology; D011174:Portugal; D065631:Rhinitis, Allergic / Q000150:complications / Q000276:immunology / Q000628:therapy*; D006255:Rhinitis, Allergic, Seasonal / Q000150:complications / Q000276:immunology / Q000628:therapy*; D018570:Risk Assessment; D013030:Spain; D055815:Young Adult
chemical_list: D000485:Allergens; D052179:Antigens, Plant
keywords: Phleum pratense; Timothy grass; immunotherapy; seasonal rhinoconjunctivitis; vaccine