Applying Systems Immunology to the Search for Personalized Biomarkers of Clinical Efficacy

NCT02931955 | Completed DMC

• 1 other identifier: SYS-T-ACT_01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Study Objective: Allergies affect up to 20% of the population of developed countries and can cause substantial individual disease burden. For some allergies, immunotherapeutic regimens ("hyposensitization") have been established, e.g. for insect venom allergies and pollen allergies. This project aims at identifying the T cell activation potential in vivo from resting T cells of patients undergoing immunotherapy (IT) via a systems biology approach. For the participants, it involves blood draws and stool collection as well as gathering some basic medical information. The participation takes one week for patients undergoing insect venom IT and three months for patients undergoing pollen IT. A control group without a clinical history of allergies is recruited. Blood and stool samples are collected in the same time frames as in allergic patients. This study is a cooperation project between the Centre Hospitalier de Luxembourg (CHL), the Luxemburg Institute of Health (LIH), the University of Luxembourg and the Integrated Biobank of Luxemburg (IBBL).

Conditions

Allergy

Keywords

allergy; insect venom; pollen; systems biology

Outcome Measures

Primary Outcomes (1)

• Predicting the effectiveness of immunotherapy against insect venom and pollens in allergic patients with use of gene expression networks.

  This study will allow to predict the T cell activation potential (by evaluating gene expression networks) in vivo before start of immunotherapy for insect venom or pollen allergy meaning that the investigators will be able to predict which patients will profit from standard immunotherapy and which patients will need to receive altered immunotherapy strategies (i.e. higher doses, longer maintenance). As this is an observational pilot study the investigators define this as outcome measure.

  Through study completion, an average of 1.5 years/April 2018

Study Arms (3)

Venom Group

The investigators plan to include 15 patients with insect venom allergy and will collect blood at four time points and stool at three time points during the first week of immunotherapy. The patients will receive usual standard of care and no intervention. We will, however, include blood draw and stool samples collection from the patients.

Other: Blood draw, stool collection.

Pollen Group

The investigators plan to include 15 patients with pollen allergy and will collect blood at five time points and stool at three time points during the first three months of immunotherapy. The patients will receive usual standard of care and no intervention. We will, however, include blood draw and stool samples collection from the patients.

Other: Blood draw, stool collection.

Control Group

The investigators plan to include 10 control persons without a clinical history of allergies. Blood and stool samples will be collected at seven/four times respectively. The patients will receive usual standard of care and no intervention.

Other: Blood draw, stool collection.

Interventions

Blood draw, stool collection. OTHER

Blood will be drawn by certified personnel according to local regulations. Stool will be collected by the patients after instructions on how to use a stool collection kit.

Control Group; Pollen Group; Venom Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will recruit participants from the allergy referral center at the CHL Luxembourg who are undergoing immunotherapy for insect venom or pollen allergy.

You may qualify if:

• patients undergoing subcutaneous immunotherapy for insect venom or pollen allergy

You may not qualify if:

• patients \< 18 years
• medical conditions preventing patients in participating in the immunotherapy
• lack of consent or lack to give consent to participate in the study

Sponsors & Collaborators

• Luxembourg Institute of Health: lead
• Integrated Biobank of Luxembourg: collaborator
• Centre Hospitalier du Luxembourg: collaborator

Study Sites (1)

Centre Hospitalier de Luxembourg

Luxembourg, 1210, Luxembourg

Location

Related Publications (1)

• Pogorelov D, Bode SFN, He X, Ramiro-Garcia J, Hedin F, Ammerlaan W, Konstantinou M, Capelle CM, Zeng N, Poli A, Domingues O, Montamat G, Hunewald O, Cire S, Baron A, Longworth J, Demczuk A, Bazon ML, Casper I, Klimek L, Neuberger-Castillo L, Revets D, Guyonnet L, Delhalle S, Zimmer J, Benes V, Codreanu-Morel F, Lehners-Weber C, Weets I, Alper P, Brenner D, Gutermuth J, Guerin C, Morisset M, Hentges F, Schneider R, Shamji MH, Betsou F, Wilmes P, Glaab E, Cosma A, Goncalves J, Hefeng FQ, Ollert M. Multiomics approaches disclose very-early molecular and cellular switches during insect-venom allergen-specific immunotherapy: an observational study. Nat Commun. 2024 Nov 26;15(1):10266. doi: 10.1038/s41467-024-54684-2.

  PMID: 39592626 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Both lymphocytes and stool samples of the patients will be retained.

MeSH Terms

Conditions

Hypersensitivity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Markus Ollert, Prof.

  Luxembourg Institute of Health

  PRINCIPAL INVESTIGATOR

• Feng Q He, PhD

  Luxembourg Institute of Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 13, 2016
• Study Start: August 1, 2016
• Primary Completion: May 2, 2018
• Study Completion: July 1, 2019
• Last Updated: May 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

LU (1)