Safety and efficacy of short-term oral immunotherapy with Cry j 1-galactomannan conjugate for Japanese cedar pollinosis: a randomized controlled trial

Sci Rep. 2017 Apr 11:7:46142. doi: 10.1038/srep46142.

Abstract

Current allergen-specific immunotherapy (AIT) for pollinosis requires long-term treatment with potentially severe side effects. Therefore, development of an AIT that is safe and more convenient with a shorter regimen is needed. This prospective, double-blind, placebo-controlled trial randomized 55 participants with Japanese cedar pollinosis (JCP) to active or placebo groups to test the safety and efficacy of short-term oral immunotherapy (OIT) with Cry j 1-galactomannan conjugate for JCP. Mean symptom-medication score as the primary outcome in the active group improved 27.8% relative to the placebo group during the entire pollen season. As the secondary outcomes, mean medication score in active group improved significantly, by 56.2%, compared with placebo during the entire pollen season. Mean total symptom score was similar between active and placebo groups during the entire pollen season. There were no severe treatment-emergent adverse events in the active and placebo groups. Therefore short-term OIT with Cry j 1-galactomannan conjugate is safe, and effective for reducing the amount of medication use for JCP.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Cryptomeria / immunology*
  • Desensitization, Immunologic / adverse effects*
  • Female
  • Galactose / analogs & derivatives
  • Humans
  • Male
  • Mannans / immunology*
  • Pollen / immunology*
  • Rhinitis, Allergic, Seasonal / immunology*
  • Rhinitis, Allergic, Seasonal / pathology
  • Rhinitis, Allergic, Seasonal / therapy*
  • Seasons
  • Treatment Outcome
  • Young Adult

Substances

  • Mannans
  • galactomannan
  • Galactose