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Completed

NCT Number: NCT02255604

Effect of Intralymphatic Immunotherapy

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.

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Key information

Conditions

Allergy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immune Tolerance Injection Site Discomfort Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lungemedicinsk Forskningsafdeling. Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

4

0.1 ml Isoton saline

Drug

4 injection into a lymphnode

Primary outcomes

  1. Change in cSMS (Combined Symptom and Medication Score)

    Time frame: 3 years

    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.

Secondary outcomes

  1. Change in Circulating Grass Specific Immunoglobulin E Producing Plasmacells

    Time frame: one week from vaccinations

Other outcomes

  1. Change in Basophil Sensitivity

    Time frame: 2 years

    Flowcytometry based analysis of basophil cells reaction to allergen provocation.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Oct 2, 2014
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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