Immunity After COVID-19 Vaccination

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 Overview

• Status: Recruiting
• Conditions: Immunity to COVID-19
• Intervention / Treatment: Other: Cellular and antibody response to spike antigens of SARS-CoV-2 in both groups in peripheral blood samples

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Ashok Reddy, BE; Phone Number: 412-224-2507; Email: info@plexision.com
• Study Contact Backup: Name: Pradeep Sethi, MD; Phone Number: 412-224-2507; Email: Pradeep.sethi@plexision.com

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Recruiting
      • Plexision
      • Contact: Ashok Reddy; Phone Number: 412-224-2507; Email: info@plexision.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy non-immunocompromized subjects; 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; 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.
Immunocompromized; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Plexision
• Investigators: Principal Investigator: Ashok Reddy, BE, Plexision

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2021
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: Pro00053511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No