Regulatory T-cells After Subcutaneous Immunotherapy

Study Overview
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Brief Summary
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The primary endpoint was the induction of T-regulatory cells under s specific subcutaneous immunotherapy (SCIT). Patients suffering from grass pollen allergy (relevant clinical symptomes during the pollen season, Skin Prick test diamter >4mm or RAST class II or higher) were included. The patients were allocated to three study groups: Group 1: during and directly after SCIT (after completion the 2nd or 3rd year of treatment) Group 2: completed SCIT more then three years ago Group 3: Patients with clinically relevant grass pollen allergy without SCIT. The investigators analyzed the lung function parameters, exhaled NO (eNO) and asked the patients to record symptoms during the adjacent pollen season. A blood sample was drawn to analyze the amount of TH1 and TH2 and regulatory T-cells, inflammatory markers(IL-2, IL-5, IL-10, IL-12/23, TNF-alpha, IFN-gamma) and blocking antibodies (IgG, IgG4).

Official Title
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Investigation of T-regulatory Cells After Subcutaneous Immunotherapy

Conditions
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Grass Pollen Allergy, Specific Immunotherapy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consent, clinically relevant grass pollen allergy, age > 6 and < 28 Exclusion Criteria: severe unstable asthma, regular ingestion of antihistamine, systemic steroid therapy, lung funtcion VC < 70%, FEV1 < 65%

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| under SIT<br>patients completed second or third year of SIT. We include the patients directly after last SIT vaccination. | |
| after SIT<br>Patients completed three years of SIT for at least three years. We included them as a follow up. | |
| no SIT<br>These patients were determined randomly. They have a clinically relevant grass pollen allergy. They never had a SIT. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction of regulatory t-cells | Determination of T-reulatory cells by FACS (staining for fox p3). | group 1: on average within one week after 4th injection of SCIT, group 2: more than three years (3-4 years) after SCIT completion, group 3: no specific time point because there was no intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TH1-cells by FACS | Staining for CD3, CD4, CD183 | group 1: on average within one week after 4th injection of SCIT, group 2: more than three years (3-4 years) after SCIT completion, group 3: no specific time point because there was no intervention | 
| Th-2 cells by FACS | Staining for CD3, CD4, CD 194 | group 1: on average within one week after 4th injection of SCIT, group 2: more than three years (3-4 years) after SCIT completion, group 3: no specific time point because there was no intervention | 
| Inflammatory cytokines | Cytokines (Il-2, Il-5, Il-10, Il-12/23, IFN-gamma, TNF-alpha) were determined by cytometric bead assay | group 1: on average within one week after 4th injection of SCIT, group 2: more than three years (3-4 years) after SCIT completion, group 3: no specific time point because there was no intervention | 
| Questionnaire | questionnaire to assess the quality of life (QoL), the clinical symptoms and medication scores during the SCIT adjacent pollen season. | During the pollen season - for group 1: pollen season directly after completion of SCIT therapy, group 2: same pollen season as group 1, three years after completion of a 3 year SCIT, group 3: same pollen season as group 1 and 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T-regulatory cells, TH1, TH2 cells, specific IgE, specific IgG, specific IgG4, IL2, IL5, IL10, IL12/23, Y-IFN, TNF-a