Effect of Intralymphatic Immunotherapy

Allergy Clinical Trial

Official title:

Effect of Intralymphatic Immunotherapy at Basophil Response and Plasmacell Kinetic in Patients With Allergic Rhinitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02255604
• Other study ID #: ILIT
• Status: Completed
• Phase: Phase 2
• Start date: August 2013
• Est. completion date: February 1, 2017

Study information

• Verified date: February 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 1, 2017
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergy
• Immune Tolerance
• Injection Site Discomfort

Intervention

Drug:
• Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.
4
• alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.
3 injection into a lymphnode
• 0.1 ml Isoton saline
4 injection into a lymphnode

Locations

Country	Name	City	State
Denmark	Lungemedicinsk Forskningsafdeling. Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Basophil Sensitivity	Flowcytometry based analysis of basophil cells reaction to allergen provocation.	2 years
Primary	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.	3 years
Secondary	Change in Circulating Grass Specific Immunoglobulin E Producing Plasmacells		one week from vaccinations