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Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis

NCT04700358 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2024-05-08

No results posted yet for this study

Summary

Most of the cystic fibrosis (CF) patients are or have been pulmonary colonized with bacteria such as Pseudomonas aeruginosa or Staphylococcus aureus. Aim of this study is to detect virulence factor neutralizing antibodies in the sera of the study population followed by B cell repertoire analyses to design B cell-derived neutralizing monoclonal antibodies. The functionality of neutralizing antibodies rests on inhibition of virulence factors by binding of crucial epitopes rather than merely the induction of opsonization. Focusing on patients with bacterial colonization/chronic infections or a history of an acute infection in the past, will increase the likelihood for identification of serum with neutralizing activity as in vivo antigen contact is a prerequisite for antibody development and maturation. Since virulence factors are essential for infection, dissemination and tissue damage, inhibition of these factors by developed neutralizing antibodies might contribute to a favorable outcome of life-threatening infections.

Conditions

  • Pulmonary Cystic Fibrosis
  • Neutralizing Antibodies

Interventions

OTHER

Blood sampling

Screening: Blood sampling of 15 ml whole blood B cell isolation: Blood sampling of max. 400 ml whole blood or 6% of the total blood volume (♀ 65 ∓ 10 ml/kg; ♂ 77 ∓ 10 ml/kg)

Sponsors & Collaborators

  • University Hospital of Cologne

    lead OTHER

Principal Investigators

  • Silke van Koningsbruggen-Rietschel, MD, PhD · University Hospital Cologne

  • Jan Rybniker, MD, PhD · University Hospital Cologne

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04700358 on ClinicalTrials.gov