Skin Test Study of BM32 | NCT01350635

Studies
Skin Test Study of BM32

NCT01350635

Sponsor

Biomay AG

Status

Completed

Last Update Posted

Dec 18, 2015Estimated

Enrollment

60Actual

Phase

Phase 1Phase 2

Conditions

Hypersensitivity

Interventions

BM32

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Jul 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

May 7, 2011

First Submission Date that Met QC Criteria

May 9, 2011

First Posted Date

May 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2015

Last Update Posted Date

Dec 18, 2015Estimated

Name	Class
Medical University of Vienna	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Name	Type	Description	Arm Group Labels	Other Names
BM32	Biological	BM32 will be applied in sterile phosphate buffer solution. Drug will be applied in concentrations of 11,33 and 100 micrograms/ml

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided