Effect of Intralymphatic Immunotherapy

NCT02255604 | Completed Phase 2 Results DMC

• 1 other identifier: ILIT
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy; Immune Tolerance; Injection Site Discomfort

Keywords

Allergic Rhinitis; Allergen immunotherapy

Outcome Measures

Primary Outcomes (1)

• Change in cSMS (Combined Symptom and Medication Score)

  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.

  3 years

Secondary Outcomes (1)

• Change in Circulating Grass Specific Immunoglobulin E Producing Plasmacells

  one week from vaccinations

Other Outcomes (1)

• Change in Basophil Sensitivity

  2 years

Study Arms (3)

intralymphatic immune therapy

ACTIVE COMPARATOR

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.

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

3 intralymphatic immune therapy

PLACEBO COMPARATOR

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.

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

no intralymphatic immune therapy

SHAM COMPARATOR

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.

Drug: 0.1 ml Isoton saline

Interventions

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

4

intralymphatic immune therapy

0.1 ml Isoton saline DRUG

4 injection into a lymphnode

no intralymphatic immune therapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Allergic rhinitis to grass pollen, more than 3 mm reaction at skin prick test for grass, age between 18 and 40 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Lungemedicinsk Forskningsafdeling. Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Hypersensitivity; Rhinitis, Allergic

Interventions

Receptor Protein-Tyrosine Kinases

Condition Hierarchy (Ancestors)

Immune System Diseases; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Hans Jürgen Hoffmann
• Organization: Aarhus Universitets Hospital

Hans.Jurgen.Hoffmann@ki.au.dk

7845000

Study Officials

• Søren Helbo SH Skaarup, MD

  Lungemedicinsk forskningsafdeling. Aarhus University Hospital.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: October 2, 2014
• Study Start: August 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: February 1, 2017
• Last Updated: May 24, 2021
• Results First Posted: March 18, 2021

Record last verified: 2017-02

Locations

DK (1)