Sublingual Immunotherapy of Birch Pollen Associated Apple Allergy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Medical University of Vienna.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Austrian Science Fund (FWF)
Information provided by (Responsible Party):
Tamar Kinaciyan, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01449786
First received: October 5, 2011
Last updated: October 7, 2011
Last verified: October 2011

October 5, 2011
October 7, 2011
December 2011
January 2013   (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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Sublingual Immunotherapy of Birch Pollen Associated Apple Allergy
Not Provided

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 daily administered sublingually as drops over 16 weeks
  • Experimental: treatment with rMal d 1
    Intervention: Drug: rMal d 1
  • Active Comparator: treatment with rBet v 1
    Intervention: Drug: rBet v 1
  • Placebo Comparator: treatment with placebo
    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.
 
Not yet recruiting
60
January 2014
January 2013   (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
Both
18 Years to 50 Years
No
Contact: Tamar Kinaciyan, MD +43 1 40400 ext 7704 tamar.kinaciyan@meduniwien.ac.at
Contact: Barbara Bohle, PhD, Prof. +43 1 40400 ext 5114 barbara.bohle@meduniwien.ac.at
Austria
 
NCT01449786
TK01/2011
Yes
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
October 2011

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