Identification of neutralizing antibodies against severe or chronic infections of human being
- Conditions
- Patients suffering from chronic infections or passing trough server infections within the last 10 years
- Registration Number
- DRKS00010169
- Lead Sponsor
- niversitätsklinikum Köln
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1000
Patients suffering from chronic infections or passing trough severe infections within the last 10 years or healthy people as volunteers, and Karnofsky > 80
-Leukopenia < 2.000 Leukocytes/µl
-Hb < 10 g/dl
-Platelets < 50.000 Plateelts/µl
-Known acquired or hereditary coagulation disorder, including anticoaguant treatment
-CHF NYHA II-IV
-COPD GOLD Stadium III-IV
-History of myocardial infarcation or current symptomatic coronary artery disease
-Symptomatic cardiac or pulmonary disease
-Body weight below 45 kg (for an apheresis or blood draw of > 250 mL, a body weight of 50 kg is required)
-< 8 (men) or 12 (women) weeks since last blood donation or blood draw volume of > 100 mL
-Within 1 week after small surgery (biopsy, tooth extraction), or within 1 month after larger surgery (e.g., thoracotomoy, open abdominal surgery) or surgery with high risk of postoperative bleeding (e.g., tonsillectomy)
-Acute or unknown health deterioration
-Participation in another interventional study
If a leukapheresis is planned, the following additional exclusion criteria apply:
-History of significant complication from leukapheresis or citrate-based anticoagulation
-INR > 1.5 or aPTT > 60 s
-Premenopausal women that cannot rule out pregnancy at the time of apheresis
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identification of neutralizing antibodies. Following methods are used:<br>1. isolation of B cells via flow cytometry ; 2. gene sequencing of antigen-coding central regions; 3. cloning and expression of identified genes; 4. functional analysis of rebuild antibodies using binding studies (ELISA, Biacore) and neutralization testings
- Secondary Outcome Measures
Name Time Method