Skin Test Study of BM32

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01350635
• Date of registration: 07/05/2011
• Primary sponsor: Biomay AG
• Public title: Skin Test Study of BM32
• Scientific title: Evaluation of BM32, a Recombinant Hypoallergenic Grass Pollen Vaccine, by Skin Testing
• Date of first enrolment: May 2011
• Target sample size: 60
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01350635
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Austria

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hypersensitivity

Intervention(s)

Biological: BM32

Primary Outcome(s)

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]

Secondary ID(s)

CS-BM32-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medical University of Vienna