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

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ClinicalTrials.gov Identifier: NCT03727399
Recruitment Status : Enrolling by invitation
First Posted : November 1, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Mabylon AG

Brief Summary:
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.

Condition or disease Intervention/treatment
Pollen Allergy Other: blood withdrawal

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Intervention Details:
  • Other: blood withdrawal
    Blood withdrawal


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727399


Locations
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Switzerland
Immunologie Zentrum Zürich
Zürich, Switzerland, 8006
Sponsors and Collaborators
Mabylon AG

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Responsible Party: Mabylon AG
ClinicalTrials.gov Identifier: NCT03727399    
Other Study ID Numbers: 2018-01110
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rhinitis, Allergic, Seasonal
Rhinitis, Allergic
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs