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Skin Test Study of BM32

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Biomay AG.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Medical University of Vienna
Information provided by:
Biomay AG
ClinicalTrials.gov Identifier:
NCT01350635
First received: May 7, 2011
Last updated: August 2, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Hypersensitivity
Biological: BM32
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of BM32, a Recombinant Hypoallergenic Grass Pollen Vaccine, by Skin Testing

Resource links provided by NLM:


Further study details as provided by Biomay AG:

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 [ Time Frame: 20 minutes ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: BM32
    BM32 will be applied in sterile phosphate buffer solution. Drug will be applied in concentrations of 11,33 and 100 micrograms/ml
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350635

Locations
Austria
Medical University
Vienna, Austria, 1090
Sponsors and Collaborators
Biomay AG
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Rainer Henning, Chief Executive Officer, Biomay AG
ClinicalTrials.gov Identifier: NCT01350635     History of Changes
Other Study ID Numbers: CS-BM32-001
Study First Received: May 7, 2011
Last Updated: August 2, 2011
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Biomay AG:
Specific Immunotherapy
Grass pollen vaccine
Allergy
Grass Pollen Allergy

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on November 25, 2014