Skin Test Study of BM32

Hypersensitivity Clinical Trial

Official title:

Evaluation of BM32, a Recombinant Hypoallergenic Grass Pollen Vaccine, by Skin Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350635
• Other study ID #: CS-BM32-001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 7, 2011
• Last updated: December 17, 2015
• Start date: May 2011
• Est. completion date: September 2011

Study information

• Verified date: December 2015
• Source: Biomay AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypersensitivity

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Biomay AG	Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes