NCT01166269

Study to Asses Efficacy of Intralymphatic Immunotherapy

Intralymphatic Specific Immunotherapy - as a New Treatment Form for Grass-pollen Allergic Subjects

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to try a new route for specific immunotherapy (SIT). The current treatment form for SIT is subcutaneously (SCIT), which is a long treatment with up to 50 injections subcutaneously in the upper arm. The investigators believe that there is additional effect if the allergen is injected directly into the lymph node, since it is here, the allergen presentation is happening. The trial has been performed in Switzerland with significant effect of only three injections of grass-allergen into a lymph node (Clinicaltrials.gov; NCT00470457). The investigators would like to see what happens if the the dose is doubled, so the patients will receive 6 injections all in all, with the same amount of allergen as the earlier study (1000 SQ-U). Also the outcome measurements is slightly different as the patients will note their symptoms in a diary. The patients will be divided into three groups using allocation: 1 group with 6 injections of allergen 1 group with 3 injections of allergen and 3 injections of placebo 1 group with 6 injections of placebo. The trial will be double blinded.

Conditions

• Allergy

Interventions

Type	Name	Description
BIOLOGICAL	phleum pratense (grass-allergen)	6 injections of grass-allergen. Every dose will be 1000 SQ-U.
BIOLOGICAL	phleum pratense (grass allergen)	3 injections of grass-allergen. Every dose will be 1000 SQ-U. Also 3 injections of placebo (physiological saline)
OTHER	physiological saline	6 injections of placebo (physiological saline)in a lymph node.

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2010-07-21
• Last updated: 2012-11-08

Locations

1 site across 1 country: Denmark