Study to Asses Efficacy of Intralymphatic Immunotherapy (ILIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01166269
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : November 8, 2012
TRYG Foundation
Information provided by (Responsible Party):
Professor, Dr. Med Hans-Joergen Malling, Rigshospitalet, Denmark

Brief Summary:

The purpose of the study is to try a new route for specific immunotherapy (SIT). The current treatment form for SIT is subcutaneously (SCIT), which is a long treatment with up to 50 injections subcutaneously in the upper arm.

The investigators believe that there is additional effect if the allergen is injected directly into the lymph node, since it is here, the allergen presentation is happening. The trial has been performed in Switzerland with significant effect of only three injections of grass-allergen into a lymph node (; NCT00470457).

The investigators would like to see what happens if the the dose is doubled, so the patients will receive 6 injections all in all, with the same amount of allergen as the earlier study (1000 SQ-U). Also the outcome measurements is slightly different as the patients will note their symptoms in a diary.

The patients will be divided into three groups using allocation:

1 group with 6 injections of allergen

1 group with 3 injections of allergen and 3 injections of placebo

1 group with 6 injections of placebo. The trial will be double blinded.

Condition or disease Intervention/treatment Phase
Allergy Biological: phleum pratense (grass-allergen) Biological: phleum pratense (grass allergen) Other: physiological saline Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intralymphatic Specific Immunotherapy - as a New Treatment Form for Grass-pollen Allergic Subjects
Study Start Date : July 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Arm Intervention/treatment
Experimental: Grass-Allergen x 6
This arm will receive 6 injections of allergen.
Biological: phleum pratense (grass-allergen)
6 injections of grass-allergen. Every dose will be 1000 SQ-U.
Active Comparator: grass-allergen x 3 and placebo x 3
this arm will receive 3 injections of allergen, and 3 injections of placebo.
Biological: phleum pratense (grass allergen)
3 injections of grass-allergen. Every dose will be 1000 SQ-U. Also 3 injections of placebo (physiological saline)
Placebo Comparator: placebo x 6
this arm will receive 6 injections of placebo.
Other: physiological saline
6 injections of placebo (physiological saline)in a lymph node.

Primary Outcome Measures :
  1. symptom improvement [ Time Frame: 2 seasons. (2 years) ]
    The patients will fill out a diary during the grasspollen-season before and after treatment. Also they will fill out a form for the general status of the season passed.

Secondary Outcome Measures :
  1. Improvement of reactivity of skin prick test and Specific IgE [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • grass pollen allergy through at least 2 seasons
  • positive skin prick test
  • positive Specific IgE of at least 2. (CAP)
  • Signed informed consent
  • for females a negative pregnancy test.

Exclusion Criteria:

  • out of age limits
  • rhinoconjunctivitis all year round.
  • uncontrolled seasonal asthma
  • patients treated with steroids continuously or beta-blockers.
  • pregnancy and breastfeeding
  • HIV, Hepatitis B+c, and other immunological diseases.
  • psychiatric disease
  • treatment with SCIT or SLIT within the last 5 years
  • participation in other clinical trials within the last 3 months.

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 identifier (NCT number): NCT01166269

Dermato-allergological dept. K
Gentofte, Hellerup, Denmark, 2900
Sponsors and Collaborators
Rigshospitalet, Denmark
TRYG Foundation
Principal Investigator: Hans-Joergen Malling, Prof. Dr. Med. Copenhagen University Hospital, Gentofte, Denmark

Responsible Party: Professor, Dr. Med Hans-Joergen Malling, Professor Dr. Med., Rigshospitalet, Denmark Identifier: NCT01166269     History of Changes
Other Study ID Numbers: ILIT
First Posted: July 21, 2010    Key Record Dates
Last Update Posted: November 8, 2012
Last Verified: November 2012

Keywords provided by Professor, Dr. Med Hans-Joergen Malling, Rigshospitalet, Denmark:
grass-pollen allergy