Although it is known that Tregs have an important role in the induction of tolerance in allergen immunotherapy, more research into the different populations is necessary. The recent developments in FOXP3-stainings together with intracellular…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Detailed analysis and functional characterization of different regulatory
T-cell subpopulations induced after VIT.
Secondary outcome
Determination of serum IgG, IgA and IgE - levels in correlation with IL-10 and
TGFβ
Background summary
Venom Immunotherapy (VIT) is an established treatment for the prevention of
anaphylactic reactions after insect stings. This protection is acquired after a
series of subcutaneous injections of purified wasp venom extracts. The
mechanism of tolerance induction is not completely understood, though a role
for regulatory T-cells (Tregs) has been shown thoroughly in previous research.
In general Tregs are subdivided in naturally occurring Tregs (nTregs) and
adaptive Tregs (aTregs). Recent studies, investigating Treg subpopulations,
showed aTregs with an nTreg phenotype, and Tregs with a combination of both
nTregs and aTregs phenotypes. These findings make us wonder about the original
Treg subdivision, and their relation in suppression of allergic reactions.
Study objective
Although it is known that Tregs have an important role in the induction of
tolerance in allergen immunotherapy, more research into the different
populations is necessary. The recent developments in FOXP3-stainings together
with intracellular cytokines (IL-4, IL-10, TGFβ and IFNγ) in the CD3+CD8- -
allergen specific (CD154+) population, make it possible to make a clear
distinction between the different Treg subtypes. Analysis of the function of
these subtypes can be evaluated by co culturing experiments.
Study design
Observational cohort study with patients routinely undergoing VIT in the
allergy clinic of the UMCG Groningen. At three timepoints, before, 6 weeks and
6 months after the start of VIT, blood samples will be obtained, in which
T-cell - populations and their function, and Immunoglobulin*s will be studied.
Study burden and risks
The charge and risks of this study compaired with the VIT routinely carried out
are minimal.
The only charge is the extra blood collected during the study. This happens at
3 times; before, 6 weeks and 6 months after starting the therapy.
No extra risks are enclosed in this study.
Hanzeplein 1
9713 GZ Groningen
Nederland
Hanzeplein 1
9713 GZ Groningen
Nederland
Listed location countries
Age
Inclusion criteria
-Severe systemic reaction after a wasp sting (Müller III - IV)
-Positive Intracutaneous Skin Test for Wasp Venom (HEIC>= 0.5 at 1 ug)
-Specific IgE wasp > 0.7 kU/l
-Age between 18-65 years old
-Patients shall give a written informed consent
Exclusion criteria
-Atopy (defined as positive Phadiatop)
-Severe asthma or emphysema, based on questionnaire; use of inhaled corticosteroids
-Symptomatic coronary heart diseases or severe (even under treatment) arterial hypertension
-Diseases with a contra-indication for the use of adrenaline
-Severe Kidney disease
-Treatment with β-blockers or immunosuppressive drugs
-Immunotherapy with venom ever or during the last 5 years with inhalant allergens
-Pregnancy, lactation or inadequate contraceptive measures
-Alcohol or Drug abuse
-Lack of co-operation or severe psychological disorders
-Systemic mastocytosis
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 | NL20270.042.07 |