Allergic Rhinitis Clinical Trial
Official title:
Intralymphatic Allergen-specific Immunity as a New Administration Route for Treatment of Pollen-induced Allergic Diseases
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)
In the first part of the study safety and clinical efficacy of ALK Alutard Birch or 5-grass
have been evaluated in a RCT with 50 patients. Active patients recieve 3 injections with 1000
SQ-U ALK Alutard or 5-grasses in a lymph node in the groin. Dose interval 4 weeks. This part
of the study is completed and published (PMID: 23374268)
In the second part of the study 60 patients participates in a RCT with intralymphatic
injections with both ALK Alutard Birch AND ALK Alutard 5-grasses. The injections are given
intralymphatically with one allergen in each groin with 30 minutes observation between
injections. Dose and dose interval are the same as in the first part of the study; the active
group recieves 1000 SQ-U ALK Alutard Birch in right groin and 1000 SQ-U 5-grasses in left
groin. The injections are given 3 times with 4 weeks interval. Enrollment and treatment is
completed and the results will be evaluated in the autumn 2015.
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