Skin Testing With Recombinant Bet v 1 and Hypoallergenic Recombinant Bet v 1 Fragments

NCT02098551 | Completed DMC

• 1 other identifier: 147/2009
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this study is to use the major allergen 1 of birch-tree pollen (Bet v 1, Betula verrucosa, synonymous Betula pendula), to investigate the contribution of immunoglobulin E (IgE)- versus non-IgE-mediated mechanisms to chronic skin inflammation in atopic dermatitis patients.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; bet v 1; bet v 1 fragments; allergy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Positive Atopy Patch Testing Reactions of Each Grade on the European Task Force on Atopic Dermatitis Scale

  Birch pollen extract (BPE), as well as rBet v 1 (160mg), rBet v 1 fragment 1 (160mg), rBet v 1 fragment 2 (160mg), and an equimolar rBet v 1 fragment mix (80mg of each rBet v 1 fragment), were applied for 48h in patch test chambers onto nonlesional skin on the backs of the subjects. After 48h, patches were removed, and reactions were analyzed and photodocumented. Grading of positive APT reactions (i.e., reactions of more than 4 mm in diameter) was done according the European Task Force on Atopic Dermatitis by a blinded investigator: -, negative result; ?, only erythema, questionable; +, erythema, infiltration; ++, erythema, few papules (\<3); +++, erythema, papules from 4 to less than many; ++++, erythema, many or spreading papules; or +++++, erythema, vesicles.

  6 months

Study Arms (1)

Four (4)

Group 1: Birch pollen-related atopic dermatitis (AD) (n=15) Group 2: Birch pollen allergic patients without AD (n=5) Group 3: Allergic individuals without birch pollen allergy (n=5) Group 4: Non-allergic individuals (n=5) Patients will be tested by SPT and APT: SPT: Histamine, buffer, commercial birch pollen extract, rBet v 1, rBet v 1 fragment 1, rBet v 1 fragment 2, and equimolar rBet v 1 fragment mix (20 and 40 μg/ml) in duplets. APT: birch pollen extract, rBet v 1, rBet v 1 fragment 1, rBet v 1 fragment 2, equimolar mix of rBet v 1 fragments (160 μg/application); negative control with vaseline

Other: SPT and APT

Interventions

SPT and APT OTHER

All patients will be tested by skin prick testing (SPT: Histamine, buffer, commercial birch pollen extract, rBet v 1 (20 and 40 μg/ml), rBet v 1 fragment 1 (20 and 40 μg/ml), rBet v 1 fragment 2 (20 and 40 μg/ml), equimolar rBet v 1 fragment mix (20 and 40 μg/ml) in duplets. Atopy patch testing (APT: birch pollen extract, rBet v 1:160 μg/application, rBet v 1 fragment 1: 160 μg/application, rBet v 1 fragment 2: 160 μg/ml, equimolar mix of rBet v 1 fragments: 160 μg/application; negative control with vaseline alone.

Four (4)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Different types of individuals will be recruited and divided in four groups. A total of 30 allergic and non-allergic persons will be included in this study: patients with Birch pollen-related atopic dermatitis (AD), Birch pollen allergic patients without AD (group 2), allergic individuals without birch pollen allergy and non-allergic individuals.

You may qualify if:

• Age between 18 and 75 years
• They will be available to complete the study

You may not qualify if:

• Severe general maladies
• Severe skin inflammation in the test area
• Risk of non-controllable general reaction
• Pregnancy and breast-feeding
• Autoimmune diseases, immune-defects including immuno-suppression, immune-complex-induced immunopathies
• Contra-indication for adrenaline
• Patients under long-term treatment with systemic corticosteroids immunosuppressive drugs, tranquilizers or psychoactive drugs
• Positive IgE reaction on hypoallergenic Bet v 1 derivatives
• The subject is currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug.
• The subject is at risk of non-compliance with the study procedures/restrictions

Sponsors & Collaborators

• Stefan Woehrl: lead
• Medical University of Vienna: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• Campana R, Moritz K, Marth K, Neubauer A, Huber H, Henning R, Blatt K, Hoermann G, Brodie TM, Kaider A, Valent P, Sallusto F, Wohrl S, Valenta R. Frequent occurrence of T cell-mediated late reactions revealed by atopy patch testing with hypoallergenic rBet v 1 fragments. J Allergy Clin Immunol. 2016 Feb;137(2):601-609.e8. doi: 10.1016/j.jaci.2015.08.042. Epub 2015 Oct 28.

  PMID: 26518092 RESULT

MeSH Terms

Conditions

Dermatitis, Atopic; Hypersensitivity

Interventions

APT

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Rudolf Valenta, MD

  Medical University of Vienna

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Mag. Dr. Stefan Wöhrl

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: March 28, 2014
• Study Start: February 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: April 1, 2013
• Last Updated: December 8, 2015

Record last verified: 2015-12

Locations

AU (1)