Screening of the immune repertoire of healthy volunteers for broadly reactive fusion-inhibiting antibodies directed against coronavirus S protein, including SARS-CoV-2
- Conditions
- CoronaCOVID-19SARS-CoV-210047438
- Registration Number
- NL-OMON49952
- Lead Sponsor
- eyden Laboratories B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1. Participant must sign the study informed consent form prior to any
study-mandated procedure indicating that he or she understands the purpose,
procedures and potential risks, and is willing to participate in the study;
2. Participant is male or female and between 40 and 65 years of age, inclusive,
at the time of enrollment;
3. Participant is willing and able to complete the study procedures;
4. Participant has a primary care physician at the time of enrollment;
5. Participant is generally healthy in the investigator*s clinical judgment, as
determined by medical history evaluation, including no clinically significant
disorder, condition, infection or disease that would interfere with the study
evaluation, procedures or completion.
1. Participant has current clinical symptoms of COVID-19 (including, but not
limited to: cough, fever, shortness of breath, sudden onset of anosmia, ageusia
or dysgeusia). Note that a participant who reports a previous positive
diagnostic test result for SARS-CoV-2 infection (serological testing or viral
RNA detection by PCR testing) and who is recovered from COVID-19 for at least
three weeks prior to blood sampling is allowed to participate in the study as
deemed by the investigator;
2. Participant had recent close contact with a SARS-CoV-2 infected person or
someone in their household tested positive for SARS-CoV-2, has travelled to a
country/area that has been designated as a COVID-19 risk area according to the
effective policies/guidelines of the National Institute for Public Health and
the Environment (Dutch: RIVM) or otherwise meet criteria for home isolation;
3. Participant received immunosuppressive medication or other immunomodulating
agents (including investigational drugs) in the 3 weeks prior to study blood
sampling or received immunoglobulins or blood products in the 3 months prior to
study blood sampling;
4. Participant with a whole blood donation or loss of >500 ml within 21 days
before study blood sampling;
5. Any known factor, condition, or disease that might interfere with
compliance, study conduct or interpretation of the results, as deemed by the
investigator.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* B-cell response as assessed by enzyme-linked immunosorbent assay (ELISA)<br /><br>and/or enzyme-linked immunosorbent spot assay (ELISpot) and/or flow cytometry<br /><br>methods<br /><br>* Serology: peptide library scanning </p><br>
- Secondary Outcome Measures
Name Time Method <p>* Prevalence of common cold as assessed by PCR-based assay for respiratory<br /><br>pathogens panel</p><br>