Effect of Intralymphatic Immunotherapy
This trial is active, not recruiting.
|Conditions||allergy, immune tolerance, injection site discomfort|
|Treatments||alk (225) phleum pratense. 0.1 ml of 10,000 standard quantity units/ml., 0.1 ml isoton saline|
|Sponsor||University of Aarhus|
|Start date||August 2013|
|End date||September 2015|
|Trial size||36 participants|
|Trial identifier||NCT02255604, ILIT|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Change in SMS (combined Symptom and Medication Score)
time frame: 2 years
Change in basophil sensitivity
time frame: 2 years
Change in circulating grass specific immunoglobulin E producing plasmacells
time frame: one week from vaccinations
Male or female participants from 18 years up to 40 years old.
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.
|Official title||Effect of Intralymphatic Immunotherapy at Basophil Response and Plasmacell Kinetic in Patients With Allergic Rhinitis.|
|Principal investigator||Søren Helbo SH Skaarup, MD|
|Description||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.|
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