Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Ashok Reddy, BE
CONTACT
Pradeep Sethi, MD
CONTACT
Lead
Plexision
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.
Age
18–100
Sex
ALL
Healthy volunteers
Not accepted
