title: Safety of an ultra-rush immunotherapy build-up schedule with therapeutic vaccines containing depigmented and polymerized allergen extracts.
abstract: BACKGROUND
  Four administration schedules of immunotherapy have been reported: conventional, cluster, rush and ultra-rush.
  
  
  OBJECTIVE
  To evaluate the safety and the clinical advantage of using standardized modified allergen extracts in an ultra-rush protocol without premedication and/or hospitalization.
  
  
  METHODS
  One thousand and sixty-eight patients with rhinoconjunctivitis and/or asthma sensitized to mites and/or pollen were included in a prospective observational study. Patients received a therapeutic vaccine containing depigmented and glutaraldehyde-modified extracts (mites and/or pollens) adsorbed onto alum prescribed by a specialist. The schedule of administration consisted of injecting 0.2 and 0.3 ml of the vial of maximum concentration during the first day of immunotherapy, separated by a time interval of 30 min. All patients reached the maximum dose (0.5 ml) after 2 injections. Tolerance was assessed by recording all side reactions related to immunotherapy, classified according to the criteria of the EAACI.
  
  
  RESULTS
  The total number of injections was 2,136. All patients reached the maximum established dose on the 1st day. No premedication was used. Seven clinically relevant local reactions were recorded. The systemic reactions were 5 grade-1 (2 immediate and 3 delayed) and 3 delayed grade-2 reactions.
  
  
  CONCLUSIONS
  The therapeutic vaccines containing chemically modified extracts can be administered using an alternative ultra-rush schedule in an immunotherapy unit, reaching the maximum dose on the 1st day with 2 injections, without the need of premedication and/or hospitalization.
authors.affiliation: Laboratorios LETI, S.L., Tres Cantos, Madrid, Spain. mcasanovas@leti.com
authors.forename: M
authors.initials: M
authors.lastname: Casanovas
authors.forename: R
authors.initials: R
authors.lastname: Martín
authors.forename: C
authors.initials: C
authors.lastname: Jiménez
authors.forename: R
authors.initials: R
authors.lastname: Caballero
authors.forename: E
authors.initials: E
authors.lastname: Fernández-Caldas
mesh_terms: D000328:Adult; D000485:Allergens / Q000008:administration & dosage / Q000627:therapeutic use*; D039741:Antigens, Dermatophagoides / Q000008:administration & dosage / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy; D003233:Conjunctivitis, Allergic / Q000188:drug therapy; D003888:Desensitization, Immunologic / Q000009:adverse effects* / Q000379:methods; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006969:Hypersensitivity, Immediate / Q000188:drug therapy*; D008297:Male; D011058:Pollen / Q000276:immunology; D011108:Polymers / Q000008:administration & dosage; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy; D014612:Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D000485:Allergens; D039741:Antigens, Dermatophagoides; D011108:Polymers; D014612:Vaccines