In vitro characterization of the immune response of recovered COVID-19 patients and healthy controls to SARS-CoV-2.
- Conditions
- CoronaCOVID-19SARS-CoV-210047438
- Registration Number
- NL-OMON50131
- Lead Sponsor
- ISA Pharmaceuticals B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
Inclusion criteria for both recovered COVID-19 patients and healthy participants
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 18 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 not taking any immunosuppressive medication or other
immunomodulating agents (including investigational drugs) for at least 3 weeks
prior to study blood sampling.
Inclusion criteria for recovered COVID-19 patients only
1. Participant reports a previous positive diagnostic test result for
SARS-CoV-2 infection (serological testing or viral RNA detection by PCR
testing);
2. Participant had clinical symptoms of COVID-19 (including, but not limited
to: cough, fever, shortness of breath, sudden onset of anosmia, ageusia or
dysgeusia). The diagnosis of COVID-19 must be the most plausible cause of the
reported symptoms, as deemed by the study physician;
3. Participant has recovered from COVID-19 for at least three weeks prior to
study blood sampling (residual symptoms such as, but not limited to, fatigue
and reduced exercise tolerance - that would not jeopardize study endpoints -
are allowed at the investigator*s discretion).
Inclusion criteria for healthy participants only
1. 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.
Exclusion criteria for both recovered COVID-19 patients and healthy participants
1. Participant with a whole blood donation or loss of >500 ml within 21 days
before study blood sampling;
2. Any known factor, condition, or disease that might interfere with
compliance, study conduct or interpretation of the results, as deemed by the
investigator.
Exclusion criteria for healthy participants only
1. Participant reports a previous positive diagnostic test result for
SARS-CoV-2 infection (serological testing or viral RNA detection by PCR
testing);
2. Participant developed clinically overt symptoms of COVID-19 following close
contact with a proven SARS-CoV-2 positive patient, but was not tested (e.g. due
to limited test capacity and regulations at that time);
3. Participant who is currently working, or has worked in an occupation with a
high risk of exposure to SARS-CoV-2 (e.g. health care worker).
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Memory T cell response as assessed by interferon-* enzyme-linked immune<br /><br>absorbent spot (ELISpot) assay and/ or enzyme-linked immunosorbent assay<br /><br>(ELISA) and intracellular cytokine staining (ICS) after stimulation of<br /><br>peripheral blood mononuclear cells (PBMCs) with each of the 20 therapeutic<br /><br>SARS-CoV-2 vaccine candidate SLPs</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Serum IgG antibodies as measured by ELISA against each of the 20 therapeutic<br /><br>SARS-CoV-2 vaccine candidate SLPs</p><br>