Skin Test Study of BM32

NCT01350635 | Completed Phase 1

• 1 other identifier: CS-BM32-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present skin test study CS-BM32-001 is to evaluate whether the BM32 proteins exhibit low/no allergenic activity when applied by skin prick- and atopy patch testing to grass pollen allergic patients

Conditions

Hypersensitivity

Keywords

Specific Immunotherapy; Grass pollen vaccine; Allergy; Grass Pollen Allergy

Outcome Measures

Primary Outcomes (1)

• wheal size of immediate type skin reactions to the mix of BM32 proteins wheal size of immediate type skin reactions to the wheal size of immediate type skin reaction to the mix of BM32 proteins

  For skin prick testing a drop of the test solution will be placed on the subjects´ skin at a distance of at least 2 cm between individual application points. The skin will be pricked with sterile prick lancets. Reactions will be recorded after 20 minutes by measuring the diameters of the wheal. Wheals of more than 3 mm diameter will be regarded as positive reactions.

  20 minutes

Interventions

BM32 BIOLOGICAL

BM32 will be applied in sterile phosphate buffer solution. Drug will be applied in concentrations of 11,33 and 100 micrograms/ml

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Positive history of grass pollen allergy and positive skin prick test reaction to grass pollen extract
• Age between 18 and 60 years
• Subjects must have a standard health care insurance
• Subject must appear capable to understand and comply with all relevant aspects of the study protocol

You may not qualify if:

• pregnancy or breast feeding
• autoimmune diseases, immune defects including immuno- suppression, immune-complex-induced immunopathies
• contra-indication for adrenaline
• severe general maladies, malignant diseases
• patients under long-term treatment with systemic corticosteroids, immunosuppressive drugs, tranquilizers or psychoactive drugs
• contra-indications for skin prick testing such as: skin inflammation in the test area, urticaria facticia, unstable or uncontrolled bronchial asthma (30)
• use of beta-blockers
• participation in another clinical trial within one month prior to the study; however, participation during the previous month solely in the form of blood donation without other interventions will be acceptable
• risk of non-compliance with the study procedure and restrictions
• use of oral H1 antihistamines within the previous 3 days, oral Ketotifen within the previous 5 days and topical corticosteroids in the test area within the previous 14 days.
• systemic (short-term) corticosteroids within the previous 14 days

Sponsors & Collaborators

• Biomay AG: lead
• Medical University of Vienna: collaborator

Study Sites (1)

Medical University

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2011
• First Posted: May 10, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

AU (1)