NCT03727399

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

7.3 years

First QC Date

October 31, 2018

Last Update Submit

April 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Antibody profiling

    Analysis and IgG profiling of specific antibodies binding major grass- and tree-pollen allergens in allergic patients.

    October 2018 - September 2021

Interventions

Blood withdrawal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Immunologie Zentrum Zürich

Zurich, Canton of Zurich, 8006, Switzerland

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 1, 2018

Study Start

October 1, 2018

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 2, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations