Accelerated Dose Escalation with 3 Injections of an Aluminum Hydroxide-Adsorbed Allergoid Preparation of 6 Grasses Is Safe for Children and Adolescents with Moderate to Severe Allergic Rhinitis

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Xenia Bovermann - , University of Lübeck, Airway Research Center North (ARCN) - DZL Borstel (Author)
  • Isabell Ricklefs - , University of Lübeck, Airway Research Center North (ARCN) - DZL Borstel (Author)
  • Christian Vogelberg - , Department of Paediatrics, TUD Dresden University of Technology (Author)
  • Ludger Klimek - , Center for Rhinology and Allergology Wiesbaden (Author)
  • Matthias V. Kopp - , University of Lübeck, Airway Research Center North (ARCN) - DZL Borstel, University of Bern (Author)

Abstract

A high-dose, accelerated escalation schedule during subcutaneous allergen-specific immunotherapy (AIT) is safe and well-tolerated in adults. However, there are no data in children and adolescents. The aim of the present trial was to assess safety and tolerability of an accelerated dose escalation schedule of an AIT with a grass pollen allergoid in children and adolescents with moderate to severe seasonal rhinoconjunctivitis in a multicenter, open-label, randomized phase II trial. The dose escalation scheme for patients in the One Strength Group included 3 injections with 1 strength B (10,000 TU/mL), whereas the dose escalation scheme for the Standard group included 7 injections with 2 strengths A (1,000 TU/mL) and B (10,000 TU/mL) of an allergoid grass pollen preparation. Overall, n = 50 children (n = 25 in each group; mean age 8.9 + 1.54 years) and n = 37 adolescents (n = 20 and n = 17; 14.2 + 1.62 years) were randomized. For all patients, the mean treatment duration was 59.4 days in the One Strength group and 88.6 days in the Standard group. Treatment-emergent adverse events (TEAEs) related to AIT were reported in 52 and 40% in children and 35 and 35.3% in adolescents, respectively. Systemic allergic reactions occurred in about 5% of our patients and were reported in more patients of the One Strength group (6.7 vs. 2.4%). All systemic reactions were classified as WAO Grade 1. Accelerated high-dose escalation with an aluminum hydroxide-adsorbed grass pollen allergoid can be initiated with a safety and tolerability profile comparable to the standard dose escalation schedule in children and adolescents with allergic rhinitis with or without asthma.

Details

Original languageEnglish
Pages (from-to)524-534
Number of pages11
JournalInternational archives of allergy and immunology
Volume182
Issue number6
Publication statusPublished - May 2021
Peer-reviewedYes

External IDs

PubMed 33503610

Keywords

ASJC Scopus subject areas

Keywords

  • Allergen-specific immunotherapy, Allergic rhinitis, Children, Cytokines, Nasal allergy tolerance/suppression