Covid19
Conditions
Keywords
serum, nasal secretions, immune response
Brief summary
This study aims to gain more insight in the immunological characteristics and immune response on a local level (the nose) and systemic level (the blood) of healthy people vaccinated with the current available COVID-19 messenger ribonucleic acid (mRNA; BNT162b2) and viral vector based (ChAdOx1) vaccines.
Detailed description
The immunological assays that will be performed on blood include immunophenotyping, serologic testing and cytokine analysis. Deep characterization of patients' immune profile offers a unique opportunity for comprehensive understanding of the mechanisms behind severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccination. The investigators will study immunological functions on the level of both adaptive and innate immunity by performing extensive immunophenotyping, cytokine analysis and RNA sequencing analysis. Biomarker analysis will be performed on protein and on RNA single cell level. Infectivity of different cell types including macrophages will performed. These analyses will be performed at the Human Immunodeficiency Virus (HIV) Cure Research Center (HCRC) laboratory. Nasal fluid: The investigators will compare the immune response and immunoglobulin production in nasal secretions before and after SARS-CoV2 vaccination. The investigators aim to compare the local versus the systemic (blood/serum) response to SARS-CoV2 vaccination. Further, patients that had a proven SARS-CoV2 infection will be compared with patients that never had COVID-19 symptoms nor antibodies. Questionnaire: a questionnaire will be filled in by the individual to assess if the individual went through a previous SARS-CoV2 infection and experienced symptoms post vaccination. The questionnaires are available as supplementary documents.
Interventions
PROCEDUREBlood and nasal fluid sampling before and after COVID-19 vaccination
Blood and nasal fluid sampling take place just before the first COVID-19 vaccination and at 14-30 days after the second dose with the same vaccine. Sampling will be repeated at 6 months after the second vaccination, at 14-30 days after the third vaccination and at 6 months after the third vaccination. At all moments, a questionnaire is filled in.
Sponsors
University Ghent
Vlaams Instituut voor Biotechnologie
University Hospital, Ghent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult (18-100 years)
Exclusion criteria
* People with a compromised immune system Active treatment with chemotherapy HIV infection with cluster of differentiation 4 (CD4) count below 200/µl Combined immunodeficiency Treatment with methylprednisolone \>16mg for more then 2 weeks Transplant patients Diagnosed Chronic Rhinosinusitis with Nasal Polyps * Known pregnancy at the time of screening * Inability to give informed consent or absence of legal representative who can give informed consent. * Any contra indication for receiving the SARS-CoV2 vaccination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SARS-CoV-2 neutralization antibody levels. | Nasal secretions and serum will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination) | In vitro qualitative determination of SARS-CoV-2 neutralization antibody in nasal secretions and serum. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in interferon gamma (IFN-γ) levels. | Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination) | Quantitative measurement of IFN-γ in blood using an immunoassay. |
| Change in interleukin 2 (IL-2) levels. | Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination) | Quantitative measurement of IL-2 in blood using an immunoassay. |
| Change in interleukin 1 (IL-1) levels. | Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination) | Quantitative measurement of IL-1 in blood using an immunoassay. |
| Change in tumor necrosis factor alpha (TNF-α) levels. | Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination) | Quantitative measurement of TNF-α in blood using an immunoassay. |
| Change in granulocyte-macrophage colony-stimulating factor (GM-CSF) levels. | Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination) | Quantitative measurement of GM-CSF in blood using an immunoassay. |
| Change of subsets of T cells with markers Cluster of Differentiation 69 (CD69), CD40 ligand (CD40L), CD137. | Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination) | Quantitative measurement of subsets of COVID-19 specific T cell responses with markers of immune activation using flow cytometry. |
| Change of SARS-CoV-2 Spike Receptor Binding Domain (RBD) binding B cells. | Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination) | Quantitative measurement of SARS-CoV-2 Spike RBD binding B cells using flow cytometry. |
| Change in interleukin 18 (IL-18) levels. | Blood will be collected just before the first vaccination (T1: pre-vaccination) and between 14 and 30 days after the second vaccination (T2: post-vaccination) | Quantitative measurement of IL-18 in blood using an immunoassay. |
Countries
Belgium
Outcome results
None listed