Safety and Efficacy Study of Intralymphatic Allergen-specific Immunotherapy
Status:
Completed
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
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)
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Karolinska Institutet
Collaborators:
Karolinska University Hospital Skane University Hospital