Immunity After COVID-19 Vaccination

Plexision

Status: Unknown

Conditions: Immunity to COVID-19

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

Study type: Observational

Funder types: Industry

Identifiers

NCT04883164

Pro00053511

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Healthy non-immunocompromized subjects

Description:

Healthy individuals are those with no pre-existing conditions that cause immune deficiency, and who are not receiving drugs to suppress the immune system. •

Treatment:

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

Immunocompromized

Description:

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.

Treatment:

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