Regulatory T-cells After Subcutaneous Immunotherapy

Grass Pollen Allergy Clinical Trial

— RTCAS  

Official title:

Investigation of T-regulatory Cells After Subcutaneous Immunotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830673
• Other study ID #: FRA-2012-SCIT
• Status: Completed
• Phase: N/A
• First received: November 20, 2012
• Last updated: July 24, 2014
• Start date: October 2011
• Est. completion date: October 2012

Study information

• Verified date: July 2014
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 28 Years

Eligibility

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%

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Grass Pollen Allergy
• Hypersensitivity
• Rhinitis, Allergic, Seasonal
• Specific Immunotherapy

Locations

Country	Name	City	State
Germany	Johann Wolfgang Goethe-university	Frankfurt/M	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No