Safety and Efficacy Study of Intralymphatic Allergen-specific Immunotherapy
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2/Phase 3

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)
    

Detailed description: 
      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.
    

Intervention name(s): ALK Alutard Birch and/or 5-grasses; ALK Diluent
Intervention type(s): Drug; Drug
Intervention description(s): 3 intralymphatic injections of 1000 SQ-U birch and/or grass allergen with 4 weeks interval.
The substance used for the three intralymphatic injections is ALK-alutard SQ Betula verrucosa® and ALK-alutard SQ 5-grasses ® under ATC-code V01AA, V04CL and V07AB which is a depot formulation for subcutaneous use.; This placebo group will receive 3 injections of 0.3% human albumin instead of active substance
Other intervention name(s): ALK Alutard Betula Verrucosa and ALK Alutard 5-grasses; Human albumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment