Is Intralymphatic Allergen Immunotherapy Effective and Safe?

Study Overview
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Brief Summary
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15 patients with moderate to severe allergic rhinitis against grass were recruited and enrolled in the study. They received three open label intralympatic grass allergen injections with the dose 1000 SQ-U each and with one month interval. The next year the patients were randomized double blind to an active or placebo booster injection of 1000 SQ-U before the pollen season. Grass specific IgG4 levels were measured before and at various time ponts after treatment.

Detailed Description
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The purpose of the study is to evaluate whether intralymphatic administration of AIT 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 aim of the present substudy is to evaluate if a randomized preseasonal ILIT booster, after three open label ILIT injections, can increase the allergen specific IgG4 antibodies, and if the IgG4 increase can be correlated to clinical effect characterized with seasonal questionnaires. The first part of the study is completed and published (PMID: 23374268)

Official Title
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Is Intralymphatic Allergen Immunotherapy Effective and Safe: a Human Randomized Clinical Trial- Substudy Borås With a Randomized Preseasonal Booster

Conditions
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Allergic Rhinitis Due to Grass Pollen

Intervention / Treatment
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* Drug: ALK Alutard 5-grasses
* Drug: ALK Diluent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-50, Seasonal allergic symptoms for birch and/or grass verified by skin prick test, Accepted informed consent Exclusion Criteria: Pregnancy or nursing Autoimmune or collagen disease (known) Cardiovascular disease Perennial pulmonary disease Hepatic disease Renal disease Cancer Any medication with a possible side-effect of interfering with the immune response Previous immuno- or chemotherapy Chronic diseases Other upper airway disease (non-allergic sinusitis, nasal polyps, chronic obstructive and restrictive lung disease) Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers) Major metabolic disease Known or suspected allergy to the study product Alcohol or drug abuse Mental incapability of coping with the study Withdrawal of informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Active Comparator: Active booster<br>After three basic open label grass allergen ILIT injections the patient is randomized to an active ILIT booster 1 year after the first treatment. | Drug: ALK Alutard 5-grasses<br>* 0.1 mL of 10 000 SQ-U/mL (1000 SQ-U) as an intralymphatic injection<br>* Other names: Grass allergen with aluminum adjuvant;|
| Placebo Comparator: Placebo booster<br>After three basic open label grass allergen ILIT injections the patient is randomized to a placebo ILIT booster 1 year after the first treatment. | Drug: ALK Diluent<br>* 0.1 mL of ALK Diluent as an intralymphatic injection<br>* Other names: Human albumin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the serum-level of timothy specific IgG4 after 1 month | Blood samples with measurement of allergen specific blocking IgG4 antibodies | Change between baseline and 1 month after treatment. | 
| Change in the serum-level of timothy specific IgG4 after 9 months | Blood samples with measurement of allergen specific blocking IgG4 antibodies | Change between baseline and 9 months after treatment. | 
| Change in the serum-level of timothy specific IgG4 2 months after booster | Blood samples with measurement of allergen specific blocking IgG4 antibodies | Change between baseline and 2 months after the booster treatment (14 months after the basic treatment). | 
| Change in the serum-level of timothy specific IgG4 10 months after booster | Blood samples with measurement of allergen specific blocking IgG4 antibodies | Change between baseline and 10 months after the booster treatment (22 months after the basic treatment). |