Effect of Intralymphatic Immunotherapy

NCT ID: NCT02255604

Last Updated: 2021-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2017-02-01

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.

Conditions

Allergy; Immune Tolerance; Injection Site Discomfort

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

intralymphatic immune therapy

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

4

3 intralymphatic immune therapy

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.

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DRUG

3 injection into a lymphnode

no intralymphatic immune therapy

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.

Group Type: SHAM_COMPARATOR

0.1 ml Isoton saline

Intervention Type: DRUG

4 injection into a lymphnode

Interventions

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

4

Intervention Type: DRUG

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

3 injection into a lymphnode

Intervention Type: DRUG

0.1 ml Isoton saline

4 injection into a lymphnode

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Søren Helbo SH Skaarup, MD

Role: PRINCIPAL_INVESTIGATOR

Lungemedicinsk forskningsafdeling. Aarhus University Hospital.

Locations

Lungemedicinsk Forskningsafdeling. Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

ILIT

Identifier Type: -

Identifier Source: org_study_id