Immunity After COVID-19 Vaccination

Study Overview
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Brief Summary
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The purpose of the research is to evaluate new blood tests, which measure immunity to the COVID-19 coronavirus after vaccination. These tests will be used to measure T-cell and antibody immunity after COVID-19 vaccination. Recent studies show that less than one-fifth of chronically immunosuppressed transplant recipients developed anti-receptor-binding domain antibodies after the first dose of the Pfizer vaccine (Boyarski, 2021). ood sampling at periodic intervals. These samples will be used to measure T-cell and antibody immunity to the COVID-19 coronavirus.

Detailed Description
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Study type: Open-label, prospective, non-randomized, observational study. Risk level. Minimal risk. Blood sampling: 10 ml each time, up to 8 times in 12 month study period for each subject, minimum interval between samples is 2 weeks. Measurements: T-cells responsive to the spike antigens of SARS-CoV-2 will be measured with flow cytometry. Antibodies specific for spike antigenic sequences will be measured with ELISA. Inclusion criteria: IRB-approved informed consent, age 18 years or older, male or female, anyone considering COVID-19 vaccination or anyone that has received COVID-19 vaccination. Subjects can enroll at anytime after vaccination even though they may not have enrolled before vaccination. For individuals previously tested at Plexision for other purposes, and who have since been vaccinated, residual cells stored for quality control and potential repeat testing will be used to establish earlier measurement of cellular and antibody immunity . Exclusion: Failure to provide informed consent Sampling Frequency and timing: Up to 8 total samples in 12 months, 10 ml per sample, no sample to be obtained less than 2 weeks after preceding sample. Samples will be obtained Before vaccination Two to four weeks after the first dose of mRNA vaccines, or after the final dose of non-mRNA vaccines which may only require a single dose Two to four weeks after the second dose of the mRNA vaccines. Month 2 after the final dose of non-mRNA vaccine which is given only once 3-monthly after the first vaccine dose until month 12. Planned enrollment: 300 total patients at least half of whom are immunocompromized. Immunocompromized patients include but are not limited to those receiving immunosuppressive or immunomodulatory drugs such as those given for autoimmune disease, inflammatory bowel disease, malignancies and transplantation. Bone marrow transplant recipients and subjects with known immune deficiency diseases are also considered immunocompromised.

Official Title
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Immunity After COVID-19 Vaccination

Conditions
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Immunity to COVID-19

Intervention / Treatment
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* Other: Cellular and antibody response to spike antigens of SARS-CoV-2 in both groups in peripheral blood samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IRB-approved informed consent, age 18 years or older, male or female, anyone considering COVID-19 vaccination or anyone that has received COVID-19 vaccination. Subjects can enroll at anytime after vaccination even though they may not have enrolled before vaccination. For individuals previously tested at Plexision for other purposes, and who have since been vaccinated, residual cells stored for quality control and potential repeat testing will be used to establish earlier measurement of cellular and antibody immunity as described in Table 1. Exclusion Criteria: Failure to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy non-immunocompromized subjects<br>Healthy individuals are those with no pre-existing conditions that cause immune deficiency, and who are not receiving drugs to suppress the immune system. • | Other: Cellular and antibody response to spike antigens of SARS-CoV-2 in both groups in peripheral blood samples<br>* Cellular immunity will be assessed with T-cells and other immune cells that express CD154 or other inflammatory or other markers after stimulation with spike antigens. Antibody immunity will be measured with binding and neutralizing activity of antibodies to spike antigens.<br>|
| Immunocompromized<br>Immunocompromised subjects are those receiving immunosuppressive or immunomodulatory drugs such as those given for autoimmune disease, inflammatory bowel disease, malignancies and transplantation. Bone marrow transplant recipients and subjects with known immune deficiency diseases are also considered immunocompromised. | Other: Cellular and antibody response to spike antigens of SARS-CoV-2 in both groups in peripheral blood samples<br>* Cellular immunity will be assessed with T-cells and other immune cells that express CD154 or other inflammatory or other markers after stimulation with spike antigens. Antibody immunity will be measured with binding and neutralizing activity of antibodies to spike antigens.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-cells and other immune cells reactive to the spike antigenic protein and its components | as above, will be measured with flow cytometry | 2 years | 
| Binding and neutralizing antibodies to the spike protein and its earlier compoent | Antibodies will be measured by ELISA | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 infection | diagnosed with PCR | 2 years |