Clinical trial NCT04883164: Immunity After COVID-19 Vaccination
Official title: Immunity After COVID-19 Vaccination
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immunity to COVID-19
Lead sponsor: Plexision
Sponsor class: INDUSTRY
First posted: 2021-05-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: T-cells and other immune cells reactive to the spike antigenic protein and its components
timeFrame: 2 years
measure: Binding and neutralizing antibodies to the spike protein and its earlier compoent
timeFrame: 2 years
Secondary outcomes:
measure: COVID-19 infection
timeFrame: 2 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Plexision
state: Pennsylvania
Study officials:
affiliation: Plexision
name: Ashok Reddy, BE
role: PRINCIPAL_INVESTIGATOR
References: