---
title: Regulatory T-cells After Subcutaneous Immunotherapy
nct_id: NCT01830673
overall_status: COMPLETED
sponsor: Johann Wolfgang Goethe University Hospital
study_type: OBSERVATIONAL
primary_condition: Grass Pollen Allergy
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01830673.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01830673"
ct_last_update_post_date: 2014-07-25
last_seen_at: "2026-05-12T06:19:13.914Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Regulatory T-cells After Subcutaneous Immunotherapy

**Official Title:** Investigation of T-regulatory Cells After Subcutaneous Immunotherapy

**NCT ID:** [NCT01830673](https://clinicaltrials.gov/study/NCT01830673)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 68
- **Lead Sponsor:** Johann Wolfgang Goethe University Hospital
- **Conditions:** Grass Pollen Allergy, Specific Immunotherapy
- **Start Date:** 2011-10
- **Completion Date:** 2012-10
- **CT.gov Last Update:** 2014-07-25

## Brief Summary

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).

## Eligibility

- **Minimum age:** 7 Years
- **Maximum age:** 28 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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%
```

## Arms

- **under SIT** — patients completed second or third year of SIT. We include the patients directly after last SIT vaccination.
- **after SIT** — Patients completed three years of SIT for at least three years. We included them as a follow up.
- **no SIT** — These patients were determined randomly. They have a clinically relevant grass pollen allergy. They never had a SIT.

## Primary Outcomes

- **Induction of regulatory t-cells** _(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)_ — Determination of T-reulatory cells by FACS (staining for fox p3).

## Secondary Outcomes

- **TH1-cells by FACS** _(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)_
- **Th-2 cells by FACS** _(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)_
- **Inflammatory cytokines** _(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)_
- **Questionnaire** _(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)_

## Locations (1)

- Johann Wolfgang Goethe-university, Frankfurt/M, Hesse, Germany

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.johann wolfgang goethe-university|frankfurt/m|hesse|germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01830673.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01830673*  
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