drugset / Trial / NCT02423707

Safety and Efficacy Study of Intralymphatic Allergen-specific Immunotherapy

NCT02423707 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Allergen-specific immunotherapy (ASIT) is commonly used to treat patients with allergic rhino-conjunctivitis and asthma, and it is the only proven treatment that affects the long-term development of allergic rhinitis and asthma. The current treatment regime of ASIT requires numerous subcutaneous allergen injections and takes several years to complete. Hence, there is a need to develop more convenient protocols for induction of allergen tolerance. Emerging evidence suggest that by targeting of antigen presenting cells within the lymph nodes the immunogenicity of the allergen can be enhanced and the number of injections can be reduced. The purpose of this study is to evaluate whether intralymphatic administration of ASIT is a safe and effective treatment for patients with pollen-induced allergic rhinitis. The long term goal is to provide a base for a more efficient administration of ASIT, which will reduce both the dose necessary and the number of clinic visits associated with the conventional subcutaneous ASIT. The investigators will make an attempt to reproduce the results of a recent human study of intralymphatic ASIT (clinicaltrials.gov; NCT00470457) in a Swedish clinical setting. The first part of the study is completed and published (PMID: 23374268)

Timeline

Start
2010-08
Primary completion
2015-11
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator 5-grasses Unknown 1000 unknown Other
Comparator ALK Alutard Birch Unknown 1000 unknown Other

Indications