Sublingual Immunotherapy of Birch Pollen Associated Apple Allergy
Recruitment status was Not yet recruiting
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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 |
- 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.
- 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 (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01449786
| 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 | |
| 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 | |
| Principal Investigator: | Barbara Bohle, PhD, Prof. | Medical University of Vienna |
| Principal Investigator: | Tamar Kinaciyan, MD | Medical University of Vienna |
More Information
| 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 Rhinitis, Allergic, Seasonal Immune System Diseases Rhinitis, Allergic Rhinitis |
Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate |
ClinicalTrials.gov processed this record on September 30, 2016