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Skin Test Study of BM32

Primary Purpose

Hypersensitivity

Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
BM32
Sponsored by
Biomay AG
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypersensitivity focused on measuring Specific Immunotherapy, Grass pollen vaccine, Allergy, Grass Pollen Allergy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Medical University

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 7, 2011
Last Updated
December 17, 2015
Sponsor
Biomay AG
Collaborators
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01350635
Brief Title
Skin Test Study of BM32
Official Title
Evaluation of BM32, a Recombinant Hypoallergenic Grass Pollen Vaccine, by Skin Testing
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biomay AG
Collaborators
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
BM32 is a hypoallergenic grass pollen allergy vaccine which consists of an aluminum hydroxide-adsorbed equimolar mix of four active ingredients, BM321, BM322, BM325 and BM326. The four active ingredients are purified recombinant proteins containing non-allergenic peptides from the four major timothy grass pollen allergens, Phl p 1 (BM321), Phl p 2 (BM322), Phl p 5 (BM325) and Phl p 6 (BM326) which are fused to the PreS domain of hepatitis B virus, a protein used in childhood vaccines. BM32 holds promise not to induce IgE mediated immediate type (e.g. anaphylactic reactions) or T-cell mediated late phase side effects during immunotherapy. The aim of the present skin test study CS-BM32-001 is to evaluate whether the BM32 proteins due to their low/absent IgE- and T cell-reactivity exhibit low/no allergenic activity when applied by skin prick- and atopy patch testing to grass pollen allergic patients (n=60). This study will therefore provide important information for immunotherapy studies based on BM32.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersensitivity
Keywords
Specific Immunotherapy, Grass pollen vaccine, Allergy, Grass Pollen Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
BM32
Intervention Description
BM32 will be applied in sterile phosphate buffer solution. Drug will be applied in concentrations of 11,33 and 100 micrograms/ml
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Medical University
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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Skin Test Study of BM32

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