Effect of Intralymphatic Immunotherapy

University of Aarhus

Status and phase: Completed; Phase 2

Conditions: Immune Tolerance; Injection Site Discomfort; Allergy

Treatments: Drug: Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.; Drug: alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.; Drug: 0.1 ml Isoton saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02255604

ILIT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups, including a placebo group

intralymphatic immune therapy

Active Comparator group

Description:

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.

Treatment:

Drug: Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.

3 intralymphatic immune therapy

Placebo Comparator group

Description:

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.

Treatment:

Drug: alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.

no intralymphatic immune therapy

Sham Comparator group

Description:

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.

Treatment:

Drug: 0.1 ml Isoton saline