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Sublingual Immunotherapy of Birch Pollen Associated Apple Allergy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01449786
First Posted: October 10, 2011
Last Update Posted: April 13, 2017
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.
Collaborator:
Austrian Science Fund (FWF)
Information provided by (Responsible Party):
Tamar Kinaciyan, MD, Medical University of Vienna
October 5, 2011
October 10, 2011
April 13, 2017
March 14, 2012
February 28, 2014   (Final data collection date for primary outcome measure)
allergen concentration to induce allergic reactions in the oral cavity as a measure of efficacy (oral provocation test) [ Time Frame: 1 year ]
To measure the clinical effects on apple-induced OAS, open food challenges (OFC) with every 30 minutes increasing doses of GMP-rMal d 1 will be performed before and after the treatment period.
Same as current
Complete list of historical versions of study NCT01449786 on ClinicalTrials.gov Archive Site
  • T cell proliferation and cytokine production as a measure of tolerance induction [ Time Frame: 1 year ]
    PBMC isolated from heparinised blood before, during and after sublingual administration of the treatment will be stimulated with titrated concentrations of rMal d 1 and rBet v 1, respectively. Proliferative and cytokine responses will be determined.
  • allergen specific antibody response [ Time Frame: 1 ]
    measurement of IgE, IgG and IgA antibodies specific for Bet v 1 and Mal d 1
T cell proliferation and cytokine production as a measure of tolerance induction [ Time Frame: 1 year ]
PBMC isolated from heparinised blood before, during and after sublingual administration of the treatment will be stimulated with titrated concentrations of rMal d 1 and rBet v 1, respectively. Proliferative and cytokine responses will be determined.
Not Provided
Not Provided
 
Sublingual Immunotherapy of Birch Pollen Associated Apple Allergy
Sublingual Immunotherapy of Birch Pollen Associated Apple Allergy

More than 70% of birch pollen allergic patients suffer from allergic reactions to certain foods, e.g. stone fruits, hazelnut and some vegetables. However, specific immunotherapy (SIT) with birch pollen extract is not effective for the treatment of associated food allergy in a substantial number of patients. Based on our previous clinical and immunological investigations of birch pollen related food allergy (BPRFA) the investigators hypothesize that for effective SIT of this abundant food allergy the disease-eliciting food allergens should be employed. To prove this concept, the investigators aim to sublingually administer the major apple allergen, Mal d 1, to birch pollen-allergic patients with concomitant apple allergy and evaluate clinical and immunological effects of this treatment. The investigators choose Mal d 1 as model food allergen because (i) its cross-reactivity with Bet v 1 has been well characterized,(ii) apple is the most frequent trigger for BPRFA and (iii) recombinant(r)Mal d 1 was well tolerated after sublingual administration to 20 birch pollen-allergic patients in a previous study. Sublingual administration of a defined concentration of GMP-rMal d 1 will be compared with equal doses of GMP-rBet v 1 as a positive control and placebo-treatment. Clinical parameters will include skin prick tests (SPT) and objective and subjective assessment of apple and birch pollen-induced allergic symptoms. Immunological parameters will comprise the analysis of antibody and T cell responses to Mal d 1 and Bet v 1 as well as the evaluation of basophil activation.

The proposed pilot study will be a first investigation of the concept to specifically treat BPRFA with the involved food allergens and thus, represents an important step in the development of an efficient and safe therapy in the future.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Birch Pollen Related Apple Allergy
  • Birch Pollen Allergy
  • Drug: rMal d 1
    25 µg daily as sublingually administered drops, 16 weeks
  • Drug: rBet v 1
    25 µg daily administered sublingually as drops over 16 weeks
  • Other: placebo drops
    25 µg of placebo Drops daily administered sublingually over 16 weeks
  • Experimental: treatment with rMal d 1
    these apple and birch pollen allergic patients are treated with daily sublingual application of 25µg recombinant Major apple allergen, Mal d 1 during 4 months
    Intervention: Drug: rMal d 1
  • Active Comparator: treatment with rBet v 1
    These apple and birch pollen allergic patients are treated with daily sublingual application of 25µg recombinant Major birch pollen allergen,Bet v 1 during 4 months
    Intervention: Drug: rBet v 1
  • Placebo Comparator: treatment with placebo drops
    These apple and birch pollen allergic patients are treated daily with placebo applied sublingually during 4 months
    Intervention: Other: placebo drops
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 20, 2016
February 28, 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • otherwise healthy persons between 18 und 50 years of age;
  • positive history of rhinoconjunctivitis to birch pollen
  • oral allergy syndrome(OAS) to apple
  • positive skin prick test (SPT) reaction to birch pollen and apple
  • specific IgE for Bet v 1 and Mal d 1

Exclusion Criteria:

  • Exclusion criteria
  • Persons who due to their physical or mental state are not able to provide informed consent.
  • Persons with underlying illnesses such as severe cardiopulmonary, malignant and/or autoimmune diseases
  • Persons suffering from Hyper-IgE syndrome
  • Persons receiving SIT during the past 5 years
  • persons suffering from severe allergic reactions to apple such as generalized urticaria, asthma and/or anaphylaxis
  • persons suffering from severe bronchial asthma to birch pollen
  • persons suffering from pathological alterations of the lips and oral mucosa
  • persons who are prescribed a treatment with immune-suppressive drugs, anti-histamines, leukotriene-antagonists or psychotropic drugs with anti-histaminic effects
  • persons using ß-blockers
  • Pregnant woman
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT01449786
TK01/2011
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Tamar Kinaciyan, MD, Medical University of Vienna
Medical University of Vienna
Austrian Science Fund (FWF)
Principal Investigator: Barbara Bohle, PhD, Prof. Medical University of Vienna
Principal Investigator: Tamar Kinaciyan, MD Medical University of Vienna
Medical University of Vienna
April 2017

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