Study to Asses Efficacy of Intralymphatic Immunotherapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Allergy

Intervention / Treatment
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* Biological: phleum pratense (grass-allergen)
* Biological: phleum pratense (grass allergen)
* Other: physiological saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: grass pollen allergy through at least 2 seasons positive skin prick test positive Specific IgE of at least 2. (CAP) Signed informed consent for females a negative pregnancy test. Exclusion Criteria: out of age limits rhinoconjunctivitis all year round. uncontrolled seasonal asthma patients treated with steroids continuously or beta-blockers. pregnancy and breastfeeding HIV, Hepatitis B+c, and other immunological diseases. psychiatric disease treatment with SCIT or SLIT within the last 5 years participation in other clinical trials within the last 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Grass-Allergen x 6<br>This arm will receive 6 injections of allergen. | Biological: phleum pratense (grass-allergen)<br>* 6 injections of grass-allergen. Every dose will be 1000 SQ-U.<br>|
| Active Comparator: grass-allergen x 3 and placebo x 3<br>this arm will receive 3 injections of allergen, and 3 injections of placebo. | Biological: phleum pratense (grass allergen)<br>* 3 injections of grass-allergen. Every dose will be 1000 SQ-U. Also 3 injections of placebo (physiological saline)<br>|
| Placebo Comparator: placebo x 6<br>this arm will receive 6 injections of placebo. | Other: physiological saline<br>* 6 injections of placebo (physiological saline)in a lymph node.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptom improvement | The patients will fill out a diary during the grasspollen-season before and after treatment. Also they will fill out a form for the general status of the season passed. | 2 seasons. (2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of reactivity of skin prick test and Specific IgE |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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grass-pollen allergy