Immunity After COVID-19 Vaccination
1 other identifier
observational
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 27, 2021
CompletedFirst Submitted
Initial submission to the registry
May 11, 2021
CompletedFirst Posted
Study publicly available on registry
May 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedMay 12, 2021
May 1, 2021
1.9 years
May 11, 2021
May 11, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
COVID-19 infection
2 years
Study Arms (2)
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. •
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Failure to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Plexisionlead
Study Sites (1)
Plexision
Pittsburgh, Pennsylvania, 15224, United States
Biospecimen
Whole blood samples, White blood cells extracted from whole blood samples, serum and plasma
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashok Reddy, BE
Plexision
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2021
First Posted
May 12, 2021
Study Start
April 27, 2021
Primary Completion
March 31, 2023
Study Completion
March 31, 2023
Last Updated
May 12, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share
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.