NCT04700358

Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis

Identification and Characterization of Antibacterial Antibodies in Sera of Patients With Cystic Fibrosis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: University Hospital of Cologne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2020-10-01
• Primary completion: 2027-09-30
• Completion: 2027-12-31
• First posted: 2021-01-07
• Last updated: 2024-05-08

Locations

1 site across 1 country: Germany