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

Atopic Dermatitis Clinical Trial

Official title:

Skin Testing With Recombinant Bet v 1 and Hypoallergenic Recombinant Bet v 1 Fragments to Dissect the Contribution of IgE to Chronic Allergic Skin Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098551
• Other study ID #: 147/2009
• Status: Completed
• Phase: N/A
• First received: July 26, 2011
• Last updated: December 6, 2015
• Start date: February 2011
• Est. completion date: April 2013

Study information

• Verified date: December 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Description:

In this study non-IgE-reactive recombinant Bet v 1 (rBet v 1) fragments (F1: aa 1-74; F2: aa 75-160) and the fully IgE-reactive recombinant Bet v 1 (aa 1-160)will be used for skin prick testing and atopy patch testing in birch pollen allergic patients with birch pollen induced exacerbation of atopic dermatitis. For control purposes birch pollen allergic patients without birch pollen-induced atopic eczema, persons with allergies other than to birch and non-allergic people will be tested.

The individuals will be subjected to in vivo skin prick and atopy patch testing with rBet v 1, rBet v 1 fragment 1, rBet v 1 fragment 2 and an equimolar mix of the rBet v 1 fragments. In parallel, the IgE reactivity, and in vitro T cell proliferation, and cytokine production will be studied. Those analyses should help to determine the relevance of IgE mediated mechanisms to chronic skin inflammation and T cell proliferation in AD patients.

A staining for the surface markers chemokine receptor (CCR4)+ and cutaneous lymphocyte antigen (CLA)+ which reportedly are enriched in inflamed skin will further allow to investigate whether patients with high numbers of T lymphocytes expressing CCR4 and CLA tend to exhibit stronger skin inflammation. Moreover, allergen-specific antibody and T cell responses will be analyzed 6-8 weeks after the epicutaneous allergen application.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2013
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 75 years

2. They will be available to complete the study

Exclusion Criteria:

1. Severe general maladies

2. Severe skin inflammation in the test area

3. Risk of non-controllable general reaction

4. Pregnancy and breast-feeding

5. Autoimmune diseases, immune-defects including immuno-suppression, immune-complex-induced immunopathies

6. Contra-indication for adrenaline

7. Patients under long-term treatment with systemic corticosteroids immunosuppressive drugs, tranquilizers or psychoactive drugs

8. Positive IgE reaction on hypoallergenic Bet v 1 derivatives

9. 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.

10. The subject is at risk of non-compliance with the study procedures/restrictions

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• SPT and APT
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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Stefan Woehrl	Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & 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, Wöhrl S, Valenta R. Frequent occurrence of T cell-mediated late reactions revealed by atopy patch testing with hypoallergenic rBe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Published Paper