Conditions: Allergy Immune Tolerance Injection Site Discomfort
Keywords: Allergic Rhinitis Allergen immunotherapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 36
Healthy volunteers: no

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.

Arms:
arm 1: 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. arm 2: 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. arm 3: 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.

Interventions: intervention 1: Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml. intervention 2: alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml. intervention 3: 0.1 ml Isoton saline
Intervention descriptions: intervention 1: 4 intervention 2: 3 injection into a lymphnode intervention 3: 4 injection into a lymphnode

Protocol document: