title: Safety and efficacy of a new regimen of short-term oral immunotherapy with Cry j 1-galactomannan conjugate for Japanese cedar pollinosis: a prospective, randomized, open-label study.
abstract: BACKGROUND
  Short-term oral immunotherapy (OIT) using the Cry j1-galactomannan conjugate for Japanese cedar pollinosis may be effective and relatively safe. However, a treatment regimen has not been established. In the present study, we examined a new OIT regimen with a build-up phase and extended the maintenance phase of OIT to the peak period of the pollen season to enhance the therapeutic effect and safety of OIT.
  
  
  METHODS
  A prospective, randomized, open-label trial was conducted over a period of 4 months. Participants were randomly divided into two groups. The OIT group comprised 23 subjects. The build-up phase was initiated 1 month before the expected pollen season. The maintenance phase was continued for 51 days during the peak pollen season. The control group comprised 24 subjects. The symptoms and medication score, levels of allergen-specific serum antibodies throughout the pollen season, and adverse effects with OIT were evaluated.
  
  
  RESULTS
  Participants receiving OIT showed significant improvements in total symptom scores, medication score, and total symptom-medication scores throughout the pollen season compared with the control group. The levels of allergen-specific serum IgG4 were significantly increased in the OIT group but not in the control group throughout the cedar pollen season. Importantly, no severe adverse effects were observed with OIT.
  
  
  CONCLUSIONS
  The new regimen of short-term OIT using the Cry j1-galactomannan conjugate for Japanese cedar pollinosis is effective, relatively safe and induces immune tolerance. Thus, OIT using allergen-galactomannan conjugates may provide a rapid, effective, and thus convenient immunotherapy for pollinosis instead of SLIT or SCIT.
authors.affiliation: Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; Department of Otorhinolaryngology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan. Electronic address: muradai@qent.med.kyushu-u.ac.jp.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Murakami
authors.affiliation: Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Motohiro
authors.initials: M
authors.lastname: Sawatsubashi
authors.affiliation: Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; Department of Otorhinolaryngology, Saitama Medical University Hospital, Saitama, Japan.
authors.forename: Sayaka
authors.initials: S
authors.lastname: Kikkawa
authors.affiliation: Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; Department of Otorhinolaryngology, Kitakyushu Municipal Medical Center, Fukuoka, Japan.
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Ejima
authors.affiliation: Biobusiness Propulsion Group, Biobusiness Propulsion Division, Wako Filter Technology Co., Ltd., Ibaraki, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Saito
authors.affiliation: Department of Biological Chemistry, Yamaguchi University, Yamaguchi, Japan.
authors.forename: Akio
authors.initials: A
authors.lastname: Kato
authors.affiliation: Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Shizuo
authors.initials: S
authors.lastname: Komune
mesh_terms: D000284:Administration, Oral; D000328:Adult; D052179:Antigens, Plant / Q000737:chemistry / Q000276:immunology*; D002452:Cell Count; D032485:Cryptomeria / Q000276:immunology; D003888:Desensitization, Immunologic / Q000009:adverse effects; D005260:Female; D005690:Galactose / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008351:Mannans / Q000737:chemistry / Q000276:immunology*; D008875:Middle Aged; D010940:Plant Proteins / Q000737:chemistry / Q000276:immunology*; D011058:Pollen; D006255:Rhinitis, Allergic, Seasonal / Q000628:therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D052179:Antigens, Plant; C065290:Cry j I protein, Cryptomeria japonica; D008351:Mannans; D010940:Plant Proteins; C012990:galactomannan; D005690:Galactose
keywords: Adverse effects; Clinical efficacy; Cry j1-galactomannan conjugate; Japanese cedar pollinosis; Oral immunotherapy