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Study to Asses Efficacy of Intralymphatic Immunotherapy (ILIT)

This study has been completed.
Sponsor:
Collaborator:
TRYG Foundation
Information provided by (Responsible Party):
Professor, Dr. Med Hans-Joergen Malling, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01166269
First received: July 20, 2010
Last updated: November 7, 2012
Last verified: November 2012
History of Changes
  Purpose

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 (Clinicaltrials.gov; 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 Intervention Phase
Allergy
 Biological: phleum pratense (grass-allergen)
Biological: phleum pratense (grass allergen)
Other: physiological saline
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intralymphatic Specific Immunotherapy - as a New Treatment Form for Grass-pollen Allergic Subjects

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • symptom improvement [ Time Frame: 2 seasons. (2 years) ] [ Designated as safety issue: Yes ]
    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:
  • Improvement of reactivity of skin prick test and Specific IgE [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: July 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166269

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

No publications provided

Responsible Party: Professor, Dr. Med Hans-Joergen Malling, Professor Dr. Med., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01166269     History of Changes
Other Study ID Numbers: ILIT
Study First Received: July 20, 2010
Last Updated: November 7, 2012
Health Authority: Denmark:Copenhagen university hospital GCP-unit

Keywords provided by Rigshospitalet, Denmark:
grass-pollen allergy

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013