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Completed

NCT Number: NCT01166269

Study to Asses Efficacy of Intralymphatic Immunotherapy

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.

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Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Dermato-allergological dept. K

Gentofte Municipality, Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

phleum pratense (grass-allergen)

Biological

6 injections of grass-allergen. Every dose will be 1000 SQ-U.

phleum pratense (grass allergen)

Biological

3 injections of grass-allergen. Every dose will be 1000 SQ-U. Also 3 injections of placebo (physiological saline)

Physiological Saline

Other

6 injections of placebo (physiological saline)in a lymph node.

Primary outcomes

  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 outcomes

  1. Improvement of reactivity of skin prick test and Specific IgE

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • TRYG Foundation

Registry information

Official study title

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

Acronym: ILIT

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 21, 2010
Registry last updated
Nov 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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