Effect of Intralymphatic Immunotherapy

Phase 2

Completed

• Conditions: Allergy; Immune Tolerance; Injection Site Discomfort
• Interventions: Drug: alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.; Drug: 0.1 ml Isoton saline

• Registration Number: NCT02255604
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-29
• Study First Posted: 2014-10-02
• Primary Completion: 2015-09
• Status Verified: 2017-02
• Study Completion: 2017-02-01
• Results First Submitted: 2020-11-10
• Results First Submitted QC: 2021-02-24
• Results First Posted: 2021-03-18
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Allergic rhinitis to grass pollen, more than 3 mm reaction at skin prick test for grass, age between 18 and 40 years.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 intralymphatic immune therapy	alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.	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.
intralymphatic immune therapy	alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.	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.
no intralymphatic immune therapy	0.1 ml Isoton saline	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.

Primary Outcome Measures

Name	Time	Method
Change in cSMS (Combined Symptom and Medication Score)	3 years	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.

Secondary Outcome Measures

Name	Time	Method
Change in Circulating Grass Specific Immunoglobulin E Producing Plasmacells	one week from vaccinations

Trial Locations

Locations (1)

Lungemedicinsk Forskningsafdeling. Aarhus University Hospital; 🇩🇰 Aarhus, Denmark