Immunity to COVID-19NCT04883164
Immunity After COVID-19 Vaccination
An observational study of Immunity to COVID-19, run by Plexision at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Immunity to COVID-19
- What is being tested?
- Cellular and antibody response to spike antigens of SARS-CoV-2 in both groups in peripheral blood samples
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2021to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Failure to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Plexision
Pittsburgh, Pennsylvania, 15224
Ashok Reddy, 412-224-2507, info@plexision.com
About this study
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.
Read the 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.
- Conditions
- Immunity to COVID-19
- Being tested
- Cellular and antibody response to spike antigens of SARS-CoV-2 in both groups in peripheral blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellular and antibody response to spike antigens of SARS-CoV-2 in both groups in peripheral blood samplesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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.
• Receives: Other: Cellular and antibody response to spike antigens of SARS-CoV-2 in both groups in peripheral blood samples | |
| 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. Receives: Other: Cellular and antibody response to spike antigens of SARS-CoV-2 in both groups in peripheral blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-cells and other immune cells reactive to the spike antigenic protein and its components
as above, will be measured with flow cytometry
Measured: 2 years
Binding and neutralizing antibodies to the spike protein and its earlier compoent
Antibodies will be measured by ELISA
Measured: 2 years
Secondary outcomes (1)
COVID-19 infection
diagnosed with PCR
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start27 Apr 2021
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunity to COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Plexision
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashok Reddy, BE, Principal investigator, Plexision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883164
- Sponsor's protocol ID
- Pro00053511
- Status last verified
- May 2021
- First submitted
- 11 May 2021
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunity After COVID-19 Vaccination
- ClinicalTrials.gov ID
- NCT04883164
- Acronym / sponsor ID
- Pro00053511
- Conditions
- Immunity to COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- PlexisionIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy non-immunocompromized subjects | – | Other: Cellular and antibody response to spike antigens of SARS-CoV-2 in both groups in peripheral blood samplesHealthy individuals are those with no pre-existing conditions that cause immune deficiency, and who are not receiving drugs to suppress the immune system. • |
| Immunocompromized | – | Other: Cellular and antibody response to spike antigens of SARS-CoV-2 in both groups in peripheral blood samplesImmunocompromised 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Failure to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cellular and antibody response to spike antigens of SARS-CoV-2 in both groups in peripheral blood samplesCellular 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. | Other | Healthy non-immunocompromized subjects, Immunocompromized |
Primary outcome
T-cells and other immune cells reactive to the spike antigenic protein and its components
Time frame: 2 years
as above, will be measured with flow cytometry
Binding and neutralizing antibodies to the spike protein and its earlier compoent
Time frame: 2 years
Antibodies will be measured by ELISA
1 secondary outcome
COVID-19 infection
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashok Reddy, BE principal investigator
Plexision
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunity to COVID-19, run by Plexision at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashok Reddy, BE (412-224-2507, info@plexision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T-cells and other immune cells reactive to the spike antigenic protein and its components (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.