Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients

March 18, 2024 updated by: Mabylon AG
The project examines the hypothesis that monoclonal allergen-neutralizing antibodies can be recombinantly produced from B lymphocytes isolated from pollen allergic patients. Patient samples suitable for antibody cloning are selected based on seroprofiling for the respective allergens. The study aims at isolating lymphocytes from patients with potential allergen-neutralizing IgG in serum and to clone antibodies from antibody gene sequences obtained from B cells of those patients.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8006
        • Immunologie Zentrum Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The project population will include adult (> 18 years) patients with a history of grass and birch pollen allergy verified by positive skin prick test and allergen-specific IgE in blood. The study population may also include patients with ongoing or completed AIT.

Description

Inclusion Criteria:

  • History of allergic rhinitis, conjunctivitis or asthma due to sensitization to grass- or birch Allergens
  • Male or female patients older than 18 years
  • Written informed consent for providing blood and also to allow experimental manipulation

Exclusion Criteria:

  • Age < 18 years
  • Any corticosteroids within the last three days
  • Oral corticosteroid therapy within the last ten days
  • Parenteral depot corticosteroids within the last three months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody profiling
Time Frame: October 2018 - September 2021
Analysis and IgG profiling of specific antibodies binding major grass- and tree-pollen allergens in allergic patients.
October 2018 - September 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mabylon AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 31, 2018

First Submitted That Met QC Criteria

October 31, 2018

First Posted (Actual)

November 1, 2018

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-01110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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