Effect of Intralymphatic Immunotherapy

University of Aarhus36 enrolled

Overview

The investigators want to investigate whether specific immunotherapy can be delivered directly into a lymph node. The investigators think that a direct introduction of allergen to the antigen presenting cells in the lymph node a give a strong immune response and that this can change the number of injections needed in allergen immunotherapy. The investigators do measurements of clinical effect and a variety of paraclinical test to see if the investigators can find af biomarker of successful specific immune therapy of grass allergy.

Patients are injected with 3 or 4 doses of alk 225 Phleum Pratense 1000 standard quantity units/ml in a lymph node in the groin. The investigators monitor clinical response and use of medication during the grass pollen season. SMS (Symptom and Medication Score) will be used. The investigators count the number of immunoglobulin E grass producing plasma cells in blood one week after each injection. The investigators also do basophil activation tests, nasal provocation tests and titrated skin prick test to monitor effect. Adverse events will be recorded.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Allergy Immune Tolerance Injection Site Discomfort

Interventions

Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.DRUG

alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.DRUG

3 injection into a lymphnode

0.1 ml Isoton salineDRUG

4 injection into a lymphnode

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Allergic rhinitis to grass pollen, more than 3 mm reaction at skin prick test for grass, age between 18 and 40 years. Exclusion Criteria: * Uncontrolled asthma. * Severe asthma with post bronchodilator test forced expiratory volume at 1 second less than 70% of expected. * Severe co morbidity. Allergy to Fenol or Aluminium hydroxid. * Any autoimmune diseases. Treatment with beta blocking medicine. * Any heart diseases. * Severe arterial hypertension. Kidney failure. * Known malignancy. Known pregnancy.

Locations (1)

Lungemedicinsk Forskningsafdeling. Aarhus University Hospital

Aarhus, Denmark

Outcomes

Primary Outcomes

Change in cSMS (Combined Symptom and Medication Score)

cSMS, Combined symptom and medication score, during grass pollen season in three years follow up. Minimal score 0, Maximal score 18. Higher score means worse outcome. Scale: Itchy/red eys: 0-3, Runny eyes: 0-3, Itchy nose: 0-3, Runny nose: 0-3, Block nose: 0-3, Sneezes: 0-3. Topical antihistamine 1.5 points/1 point. Nasal corticosteroid: 1 point/2 points. Oral antihistamine: 6 points/1 point. Oral prednisolon 1.5 point /3 points. Elements are summed to a combined score. Different combination methods exists. EAACI recommends means, i.e. symptoms 0-3 plus medicationscore 0-3. This scoringsystem was applied in the last follow-up year.

Time frame: 3 years

Secondary Outcomes

Change in Circulating Grass Specific Immunoglobulin E Producing Plasmacells

Time frame: one week from vaccinations

Data from ClinicalTrials.gov

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