Sublingual Immunotherapy of Birch Pollen Associated Apple Allergy

NCT ID: NCT01449786

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-14
• Study Completion Date: 2016-12-20

Brief Summary

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.

Conditions

Birch Pollen Related Apple Allergy; Birch Pollen Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

rMal d 1

Intervention Type: DRUG

25 µg daily as sublingually administered drops, 16 weeks

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

Group Type: ACTIVE_COMPARATOR

rBet v 1

Intervention Type: DRUG

25 µg daily administered sublingually as drops over 16 weeks

treatment with placebo drops

These apple and birch pollen allergic patients are treated daily with placebo applied sublingually during 4 months

Group Type: PLACEBO_COMPARATOR

placebo drops

Intervention Type: OTHER

25 µg of placebo Drops daily administered sublingually over 16 weeks

Interventions

rMal d 1

25 µg daily as sublingually administered drops, 16 weeks

Intervention Type: DRUG

rBet v 1

25 µg daily administered sublingually as drops over 16 weeks

Intervention Type: DRUG

placebo drops

25 µg of placebo Drops daily administered sublingually over 16 weeks

Intervention Type: OTHER

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Austrian Science Fund (FWF)

OTHER

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Tamar Kinaciyan, MD

MD, Ass.Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara Bohle, PhD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Tamar Kinaciyan, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

TK01/2011

Identifier Type: -

Identifier Source: org_study_id