Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis

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Conditions studied: Pulmonary Cystic Fibrosis, Neutralizing Antibodies

In brief

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.

Key facts

Study ID

NCT04700358

Run by

University Hospital of Cologne

People needed

75

Starts

2020-10-01

Expected to finish

2027-12-31

Last updated by the study team

2024-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age ≥ 18 years
• Ability to give consent
• Normal vital signs including:
• Blood pressure systolic value 150 - 100 mmHg, diastolic value < 90 mmHg
• Respiratory rate < 20/min
• Oxygen saturation >92%
• Heart rate 50 - 110/min
• Body temperature <38°C

You may not qualify if…

• Cytopenia (leukocytes < 1.500/µl, thrombocytes < 50.000/µl, Hemoglobin < 12 g/dl)
• Heart disease or pulmonary hypertension
• Body weight <50 kg (exclusion of blood sampling for B cell isolation)
• Blood donation, larger blood loss and/or major surgery in the last 8 (male) or 12 (female) weeks
• Any decline of the general state of health in the last 3 month including weight loss > 2kg, pulmonal exacerbation or increased impairment of pulmonary function (FEV1 < 50%)

Where it is running

• CF Study Center, University Hospital Cologne — Cologne, Germany (enrolling)

Full record on ClinicalTrials.gov

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