NCT02255604

Effect of Intralymphatic Immunotherapy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergy
• Immune Tolerance
• Injection Site Discomfort

Interventions

Type	Name	Description
DRUG	Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.	4
DRUG	alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.	3 injection into a lymphnode
DRUG	0.1 ml Isoton saline	4 injection into a lymphnode

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-09-01
• Completion: 2017-02-01
• First posted: 2014-10-02
• Last updated: 2021-05-24
• Results posted: 2021-03-18

Locations

1 site across 1 country: Denmark