Recruiting

Immunity

Sponsor:

Plexision

Code:

NCT04883164

Conditions

Immunity to COVID-19

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Immunity to COVID-19

Study ID

NCT04883164

Start date

Apr 27, 2021

Status verified date

May, 2021

Completion date

Mar 31, 2023

Anticipated

Primary completion date

Mar 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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 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.

Primary outcome measure

  • T-cells and other immune cells reactive to the spike antigenic protein and its components [ Time Frame: 2 years ]
  • Binding and neutralizing antibodies to the spike protein and its earlier compoent [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Ashok Reddy, BE

412-224-2507info@plexision.com

Pradeep Sethi, MD

412-224-2507Pradeep.sethi@plexision.com

Locations

Plexision

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Ashok Reddy

412-224-2507info@plexision.com

More Information

Sponsor

Plexision

Last update posted

May 12, 2021

Last verified

May, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Plexision on 2021-05-12.