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Trial record 2 of 2 for:    FIND-AF

Effect of Intralymphatic Immunotherapy

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ClinicalTrials.gov Identifier: NCT02255604
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Allergy Immune Tolerance Injection Site Discomfort 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 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Intralymphatic Immunotherapy at Basophil Response and Plasmacell Kinetic in Patients With Allergic Rhinitis.
Study Start Date : August 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : February 1, 2017

Arm Intervention/treatment
Active Comparator: 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.

Drug: Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.
4

Placebo Comparator: 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.

Drug: alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.
3 injection into a lymphnode

Sham Comparator: 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.

Drug: 0.1 ml Isoton saline
4 injection into a lymphnode




Primary Outcome Measures :
  1. Change in SMS (combined Symptom and Medication Score) [ Time Frame: 2 years ]
    During grass pollen season


Secondary Outcome Measures :
  1. Change in basophil sensitivity [ Time Frame: 2 years ]
  2. Change in circulating grass specific immunoglobulin E producing plasmacells [ Time Frame: one week from vaccinations ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255604


Locations
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Denmark
Lungemedicinsk Forskningsafdeling. Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Søren Helbo SH Skaarup, MD Lungemedicinsk forskningsafdeling. Aarhus University Hospital.

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02255604     History of Changes
Other Study ID Numbers: ILIT
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: February 2017

Keywords provided by University of Aarhus:
Allergic Rhinitis
Allergen immunotherapy