Overview

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
Phase phase 2
Sponsor University of Aarhus
Start date August 2013
End date September 2015
Trial size 36 participants
Trial identifier NCT02255604, ILIT

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml. Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015.
alk (225) phleum pratense. 0.1 ml of 10,000 standard quantity units/ml.
4
(Placebo Comparator)
Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml. Patients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection.
alk (225) phleum pratense. 0.1 ml of 10,000 standard quantity units/ml.
3 injection into a lymphnode
(Sham Comparator)
Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline. Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control.
0.1 ml isoton saline
4 injection into a lymphnode

Primary Outcomes

Measure
Change in SMS (combined Symptom and Medication Score)
time frame: 2 years

Secondary Outcomes

Measure
Change in basophil sensitivity
time frame: 2 years
Change in circulating grass specific immunoglobulin E producing plasmacells
time frame: one week from vaccinations

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Aarhus.