The aim of the study is to determine the biological activity of new extracts from various allergens, which will in general be used as new in house reference (IHR).
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
allergie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The test parameter is the sum of diameters of the erythema 20 minutes after
intracutanous injection of the allergen extract dilution. The sum is determined
by the sum of the longest diameter of the redness and the mid-point diameter
perpendicular to the longest diameter. From the main study parameter the
biological alergy units of the extract will be calculated.
Secondary outcome
No secondary parameters will be determined.
Background summary
In vivo characterization of allergen extracts is the determination of the
biological activity of an extract by means of skin testing. In vivo
characterization is needed to enhance the safe and possibly effective use of
allergen extracts. The regulatory authorities require in vivo characterization
of allergen extracts. There are different methods for in vivo characterization.
HAL Allergy B.V. has chosen the system of Allergy Units (AU) as established by
The Center for Biologics Evaluation and Research of the FDA. This method was
proposed by P.C. Turkeltaub and named the ID50EAL method.
Study objective
The aim of the study is to determine the biological activity of new extracts
from various allergens, which will in general be used as new in house reference
(IHR).
Study design
Observational study with invasive mesurements.
Study burden and risks
The burden for the subjects in this study is relatively small and participation
is voluntary. During one morning or one afternoon the subject will undergo
series of skin tests and receive a financial compensation. Serious allergic
reactions to these tests are not frequent, however, IgE-mediated local and/or
systemic reactions can occur. This study will serve the development of safe and
possibly effective products for immunotherapy for allergic rhinoconjunctivitis
/ asthma of which the subjects suffer themselves.
J.H. Oortweg 15
2333 CH Leiden
Nederland
J.H. Oortweg 15
2333 CH Leiden
Nederland
Listed location countries
Age
Inclusion criteria
1. Subjects who give a positive reaction on the skin prick test (sum of erythema diameters ><= 40 mm) with the extract of interest
2. Subjects with a skin colour from which erythema can be readily distinguished
3. Age between 18 and 65 years
4. Subjects shall give a written informed consent
Exclusion criteria
1. Treatment with immunotherapy (IT) of the involved allergen during the last 5 years
2. The use of oral and/or local antihistamines in the last 4 days
3. The use of oral corticosteroids or mast cell stabilizers in the last 48 hours
4. Pregnancy
5. Lack of cooperation or severe psychological disorders
6. Negative control in the SPT sum of wheal diameters > 5 mm
7. Positive control in the SPT sum of erythema diameters * 30 mm
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27908.008.09 |