A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy

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: NCT00470457
Recruitment Status : Completed
First Posted : May 7, 2007
Last Update Posted : December 3, 2015
Information provided by:
University of Zurich

May 4, 2007
May 7, 2007
December 3, 2015
June 2001
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Safety efficacy and toxicity [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT00470457 on Archive Site
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A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy
A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy in Grass and/or Tree Pollen Allergic Subjects by Intralymphatic Allergen Administration

Allergen specific immunotherapy (SIT) is the only causative treatment of IgE-mediated allergies. The disadvantages of SIT, however, are the requirement of numerous allergen administrations over three to five years, and that the treatment itself causes frequent allergic reactions. We aim at enhancing grass pollen SIT in hay fever patients by injecting the allergen directly into subcutaneous lymph nodes. In a monocentric randomized trial safety and efficacy of intralymphatic immunotherapy (ILIT) with 3 low dose grass pollen extract injections over 2 months are compared to subcutaneous immunotherapy (SCIT) using 54 injections over 3 years.

  • Trial with immunodulatory product / biological
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Rhinoconjunctivitis Due to Grass Pollen Allergy
Biological: Allergen specific immunotherapy
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Senti G, Prinz Vavricka BM, Erdmann I, Diaz MI, Markus R, McCormack SJ, Simard JJ, Wüthrich B, Crameri R, Graf N, Johansen P, Kündig TM. Intralymphatic allergen administration renders specific immunotherapy faster and safer: a randomized controlled trial. Proc Natl Acad Sci U S A. 2008 Nov 18;105(46):17908-12. doi: 10.1073/pnas.0803725105. Epub 2008 Nov 10.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2005
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Inclusion criteria:

  • Written informed consent
  • History of allergic rhino-conjunctivitis in spring and summer
  • Age 18 years to 65 years
  • Positive skin prick test to grass pollen

Exclusion criteria:

  • Blood donation within previous 30 days
  • Surgery within the previous 30 days
  • Use of investigational drugs within previous 90 days
  • Pregnancy or nursing
  • Mastocytosis
  • Significant cardiovascular disease
  • Hypertension
  • Active infectious disease
  • Significant hepatic disease
  • Significant renal disease
  • Significant hematological disorder
  • Significant pulmonary disease
  • Moderate or severe asthma
  • Autoimmune disease
  • History of malignancy.
  • Contraindicated medications were immunosuppressive agents, beta-blockers, ACE-inhibitors, and tricyclic antidepressants.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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University of Zurich
Study Director: Studienregister MasterAdmins UniversitaetsSpital Zuerich
University of Zurich
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP