title: Safety of immunotherapy with glutaraldehyde modified allergen extracts in children and adults.
abstract: BACKGROUND
  Glutaraldehyde-modified natural allergen extracts show significant reduction in the IgE-binding capacity and proteolytic activity. This allows the administration of higher doses in a shorter period of time, and to mix different allergen extracts.
  
  
  OBJECTIVE
  Evaluate the safety of different concentrations and mixtures of glutaraldehyde-modified allergen extracts in a large group of paediatric and adult patients undergoing specific immunotherapy treatment.
  
  
  METHODS
  1855 patients (1156 adults and 699 children), suffering from rhinoconjunctivitis and/or asthma, participated in an observational multicentre cohort study, to evaluate the safety of immunotherapy using vaccines containing modified allergen extracts. Patients were monosensitised, or polysensitised, and received a therapeutic vaccine containing polymerised allergen extracts adsorbed onto aluminium hydroxide. Safety was assessed by recording all side reactions related to immunotherapy.
  
  
  RESULTS
  The clinically relevant local reactions totalled 120, (90 immediate and 30 delayed) (1.02% of injections). Of them, 31 (0.26% of injections) occurred in children (26 immediate and 5 delayed) and 89 (0.76% of injections) in adults (64 immediate and 25 delayed). There were 38 systemic reactions. Eleven reactions were immediate (9 of grade 1 and 2 of grade 2) and 27 delayed (22 of grade 1 and 5 of grade 2). There were seven grade 2 systemic reactions (0.06% of the injections). No differences (P>0.05) in the number of reactions were observed between adults and children and between treatments were found in systemic reactions. All systemic reactions were mild and resolved spontaneously without the need of medication.
  
  
  CONCLUSIONS
  Specific immunotherapy using natural modified allergen vaccines is safe to treat allergic patients, even at higher doses and in mixtures of unrelated allergen extracts. The percentage of adverse reactions detected is lower than those reported in the literature with native unmodified allergen extracts.
authors.affiliation: Inmunotek S.L., Parque Tecnológico de Alcalá de Henares, Calle Punto Mobi, 5, 28805 Alcalá de Henares, Madrid, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Guzmán-Fulgencio
authors.affiliation: Inmunotek S.L., Parque Tecnológico de Alcalá de Henares, Calle Punto Mobi, 5, 28805 Alcalá de Henares, Madrid, Spain.
authors.forename: R
authors.initials: R
authors.lastname: Caballero
authors.affiliation: Inmunotek S.L., Parque Tecnológico de Alcalá de Henares, Calle Punto Mobi, 5, 28805 Alcalá de Henares, Madrid, Spain.
authors.forename: B
authors.initials: B
authors.lastname: Lara
authors.affiliation: Inmunotek S.L., Parque Tecnológico de Alcalá de Henares, Calle Punto Mobi, 5, 28805 Alcalá de Henares, Madrid, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Mena
authors.affiliation: Inmunotek S.L., Parque Tecnológico de Alcalá de Henares, Calle Punto Mobi, 5, 28805 Alcalá de Henares, Madrid, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Tejera
authors.affiliation: Inmunotek S.L., Parque Tecnológico de Alcalá de Henares, Calle Punto Mobi, 5, 28805 Alcalá de Henares, Madrid, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Sastre
authors.affiliation: Inmunotek S.L., Parque Tecnológico de Alcalá de Henares, Calle Punto Mobi, 5, 28805 Alcalá de Henares, Madrid, Spain.
authors.forename: J-L
authors.initials: JL
authors.lastname: Subiza
authors.affiliation: Inmunotek S.L., Parque Tecnológico de Alcalá de Henares, Calle Punto Mobi, 5, 28805 Alcalá de Henares, Madrid, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Fernández-Caldas
authors.affiliation: Inmunotek S.L., Parque Tecnológico de Alcalá de Henares, Calle Punto Mobi, 5, 28805 Alcalá de Henares, Madrid, Spain. Electronic address: mcasanovas@inmunotek.com.
authors.forename: M
authors.initials: M
authors.lastname: Casanovas
mesh_terms: D000328:Adult; D039741:Antigens, Dermatophagoides / Q000737:chemistry / Q000627:therapeutic use*; D001249:Asthma / Q000276:immunology / Q000628:therapy*; D002648:Child; D002908:Chronic Disease; D015331:Cohort Studies; D045424:Complex Mixtures / Q000737:chemistry / Q000627:therapeutic use*; D003888:Desensitization, Immunologic / Q000379:methods*; D005976:Glutaral / Q000737:chemistry*; D006801:Humans; D007073:Immunoglobulin E / Q000378:metabolism; D058105:Polymerization; D012220:Rhinitis / Q000276:immunology / Q000628:therapy*; D012852:Sinusitis / Q000276:immunology / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D039741:Antigens, Dermatophagoides; D045424:Complex Mixtures; D007073:Immunoglobulin E; D005976:Glutaral
keywords: Allergen immunotherapy; Asthma; Glutaraldehyde-modified allergen extracts; Mites; Pollens; Rhinoconjunctivitis; Safety