Study to Asses Efficacy of Intralymphatic Immunotherapy (ILIT)

Intralymphatic Specific Immunotherapy - as a New Treatment Form for Grass-pollen Allergic Subjects

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.

Study Overview

• Status: Completed
• Conditions: Allergy
• Intervention / Treatment: Biological: phleum pratense (grass-allergen); Biological: phleum pratense (grass allergen); Other: physiological saline

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Hellerup
    • Gentofte, Hellerup, Denmark, 2900
      • Dermato-allergological dept. K

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
symptom improvement	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.	2 seasons. (2 years)

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement of reactivity of skin prick test and Specific IgE	2 years

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: TRYG Foundation
• Investigators: Principal Investigator: Hans-Joergen Malling, Prof. Dr. Med., Copenhagen University Hospital, Gentofte, Denmark

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: July 20, 2010
• First Submitted That Met QC Criteria: July 20, 2010
• First Posted (Estimate): July 21, 2010

Study Record Updates

• Last Update Posted (Estimate): November 8, 2012
• Last Update Submitted That Met QC Criteria: November 7, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: grass-pollen allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: ILIT