Regulatory T-cells After Subcutaneous Immunotherapy

Johann Wolfgang Goethe University Hospital68 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Grass Pollen Allergy Specific Immunotherapy

Eligibility

Sex: ALLMin age: 7 YearsMax age: 28 Years

Medical Language ↔ Plain English

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%

Locations (1)

Outcomes

Primary Outcomes

Induction of regulatory t-cells

Determination of T-reulatory cells by FACS (staining for fox p3).

Time frame: 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 Outcomes

TH1-cells by FACS

Staining for CD3, CD4, CD183

Th-2 cells by FACS

Staining for CD3, CD4, CD 194

Inflammatory cytokines

Cytokines (Il-2, Il-5, Il-10, Il-12/23, IFN-gamma, TNF-alpha) were determined by cytometric bead assay

Questionnaire

questionnaire to assess the quality of life (QoL), the clinical symptoms and medication scores during the SCIT adjacent pollen season.

Time frame: 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