Regulatory T-cells After Subcutaneous Immunotherapy

NCT01830673 | Completed

• 1 other identifier: FRA-2012-SCIT
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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).

Conditions

Grass Pollen Allergy; Specific Immunotherapy

Keywords

T-regulatory cells; TH1, TH2 cells; specific IgE; specific IgG; specific IgG4; IL2; IL5; IL10; IL12/23; Y-IFN; TNF-a

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• TH1-cells by FACS

  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

  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

  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

  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

Study Arms (3)

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.

Eligibility Criteria

• Age: 7 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 7-28 years of age with house grass pollen allergy

You may qualify if:

• informed consent,
• clinically relevant grass pollen allergy,
• age \> 6 and \< 28

You may not qualify if:

• severe unstable asthma,
• regular ingestion of antihistamine,
• systemic steroid therapy,
• lung funtcion VC \< 70%,
• FEV1 \< 65%

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead

Study Sites (1)

Johann Wolfgang Goethe-university

Frankfurt/M, Hesse, 60590, Germany

Location

Related Publications (5)

• Zielen S, Kardos P, Madonini E. Steroid-sparing effects with allergen-specific immunotherapy in children with asthma: a randomized controlled trial. J Allergy Clin Immunol. 2010 Nov;126(5):942-9. doi: 10.1016/j.jaci.2010.06.002. Epub 2010 Jul 10.

  PMID: 20624650 BACKGROUND

• Martin M, Michalek SM, Katz J. Role of innate immune factors in the adjuvant activity of monophosphoryl lipid A. Infect Immun. 2003 May;71(5):2498-507. doi: 10.1128/IAI.71.5.2498-2507.2003.

  PMID: 12704121 BACKGROUND

• Drachenberg KJ, Heinzkill M, Urban E, Woroniecki SR. Efficacy and tolerability of short-term specific immunotherapy with pollen allergoids adjuvanted by monophosphoryl lipid A (MPL) for children and adolescents. Allergol Immunopathol (Madr). 2003 Sep-Oct;31(5):270-7. doi: 10.1016/s0301-0546(03)79195-2.

  PMID: 14572416 BACKGROUND

• Rosewich M, Schulze J, Eickmeier O, Telles T, Rose MA, Schubert R, Zielen S. Tolerance induction after specific immunotherapy with pollen allergoids adjuvanted by monophosphoryl lipid A in children. Clin Exp Immunol. 2010 Jun;160(3):403-10. doi: 10.1111/j.1365-2249.2010.04106.x. Epub 2010 Mar 16.

  PMID: 20345983 BACKGROUND

• Rosewich M, Schulze J, Fischer von Weikersthal-Drachenberg KJ, Zielen S. Ultra-short course immunotherapy in children and adolescents during a 3-yrs post-marketing surveillance study. Pediatr Allergy Immunol. 2010 Feb;21(1 Pt 2):e185-9. doi: 10.1111/j.1399-3038.2009.00953.x. Epub 2009 Dec 8.

  PMID: 20003062 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

Study Officials

• Stefan Zielen, Prof.

  Johann Wolfgang Goethe University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: April 12, 2013
• Study Start: October 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: July 25, 2014

Record last verified: 2014-07

Locations

DE (1)