Primary objective: To evaluate if the supernatant of allergen challenged basophils from non-systemic sensitized patients result in little, if any, activation of indicator basophils, whereas the supernatant of allergen challenged basophils from…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
CD63 and CD203c expression on basophils.
Secondary outcome
Detection and comparison of factors in supernatant of basophils from
anaphylactically sensitized patients compared to non-anaphylactically
sensitized patients.
Background summary
Patients with a history of an anaphylactic sting reaction and a positive
skin-prick test and/or positive specific immunotlobulin E (sIgE) only have a
risk of 50-60% of a re-systemic reaction. Discrepancies between sensitization
and clinical allergy form a bottleneck in selecting patients eligible for
immunotherapy. Only sting challenges with living insects allow an estimation of
the prognosis with respect to the risk of, and severity of a systemic reaction
on subsequent stings. we propose to develop a functional in vitro assay to
predict anaphylactig reaction in vivo.
Study objective
Primary objective: To evaluate if the supernatant of allergen challenged
basophils from non-systemic sensitized patients result in little, if any,
activation of indicator basophils, whereas the supernatant of allergen
challenged basophils from anaphylactically sensitized patients result in
considerable activation of indicator basophils.
Secondary objective: To investigate shich fator(s) supernatant contains that
could cause the observed basophil degranulation in vitro.
Study design
Observational case-control study
Study burden and risks
There is no risk in relation to the participation in this stud and the burden
is minimal, as only at one time point a 20 ml blood sample is drawn.
Postbus 30.001
Groningen 9700 RB
NL
Postbus 30.001
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
- A clear positive history of a systemic response grade IV or a large local reaction after a vespid sting*
- Vespid specific serum IgE > 0.70 kUA/l or a positive intracutaneous skin test for vespid venom (at <= 1 µg/ml)*
- Written informed consent
*These inclusion criteria do not apply to the indicator subjects
Exclusion criteria
- Age under 18 years
- Incapacitated subjects
- Conditions that influence the immune system (immune deficiencies, malignancy, auto-immune diseases)
- Pregnancy (measured before inclusion by β-hCG)
- Mastocytosis;Extra exclusion criteria for indicator subjects:
- A positive history of a large local or systemic response after a Hymenoptera sting
- Vespid specific serum IgE > 0.30 kUA/l
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL44083.042.13 |