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.

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.

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

Subjects 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.
• Medication history such as immunosuppressive or immune modulatory drugs that are being used,
• Underlying conditions related to immunosuppressive or immunomodulatory drug use, type of COVID-19 vaccine and doses received at the time of enrollment.
• Other underlying conditions such as diabetes, hypertension and asthma.

Plexision offers antibody testing of IgG to RBD and spike proteins as clinical tests to look for infection status. Because these tests are being used to perform antibody immunity testing after vaccination in this study, Plexision will inform participants about results of this testing as they become available.