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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Birch Pollen Related Apple Allergy
Birch Pollen Allergy
 Drug: rMal d 1
Drug: rBet v 1
Other: placebo drops
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.
Estimated Enrollment: 60
Study Start Date: December 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment with rMal d 1 Drug: rMal d 1
25 µg daily as sublingually administered drops, 16 weeks
Active Comparator: treatment with rBet v 1 Drug: rBet v 1
25 µg daily administered sublingually as drops over 16 weeks
Placebo Comparator: treatment with placebo Other: placebo drops
25 µg of placebo daily administered sublingually as drops over 16 weeks

  Eligibility
Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449786

Contacts
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

Locations
Austria
Medical University of Vienna Not yet recruiting
Vienna, Austria, 1090
Contact: Tamar Kinaciyan, MD    +43140400 ext 7704    tamar.kinaciyan@meduniwien.ac.at   
Contact: Barbara Bohle, PhD, Prof    +43140400 ext 5114    barbara.bohle@meduniwien.ac.at   
Principal Investigator: Barbara Bohle, PhD, Prof.         
Principal Investigator: Tamar Kinaciyan, MD         
Sponsors and Collaborators
Medical University of Vienna
Austrian Science Fund (FWF)
Investigators
Principal Investigator: Barbara Bohle, PhD, Prof. Medical University of Vienna
Principal Investigator: Tamar Kinaciyan, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: Tamar Kinaciyan, MD, MD, Ass.Prof., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01449786     History of Changes
Other Study ID Numbers: TK01/2011
Study First Received: October 5, 2011
Last Updated: October 7, 2011
Health Authority: Austria: BASG - Bundesamt für Sicherheit im Gesundheitswesen
(Federal Institute for Safety and Health Austria:)

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on March 01, 2015