This study is being done because the investigators would like to learn more about how well the COVID-19 vaccine works in participants with cancer or those who have received a transplant or cellular therapy. Primary Objective Assess the immunogenicity to COVID-19 vaccination in patients with cancer and/or transplant and cellular therapy (TCT) recipients. Secondary Objectives * Evaluate the antibodies response to COVID-19 vaccination in immunocompromised patients. * Evaluate the T cell response to COVID-19 vaccination in immunocompromised patients. Exploratory Objectives * Assess incidence and severity of COVID-19 infections by 6 months following immunization with a SARS CoV-2 vaccine. * Assess the durability immune response to COVID-19 vaccination. * Assess the immunogenicity of COVID-19 vaccination in immunocompetent children and adolescents without cancer and have not undergone transplant or received cellular therapy.
The investigator will collect a blood sample (about 1 teaspoon each time) from the participant when the participant receive the COVID-19 vaccine(s) as well as an additional blood samples 6 months after the last COVID-19 vaccine. The participant will be on the study for about 6 months after the last vaccine. After the six-month blood sample is collected, the participant will be off study.
Study Type
OBSERVATIONAL
Enrollment
21
Le Bonheur
Memphis, Tennessee, United States
LeBonheur
Memphis, Tennessee, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Proportion of participants with immunogenicity following full vaccination (6 months after last dose).
The primary endpoint is immunogenicity response following full vaccination measured at 6 months after the last vaccine dose. Immunogenicity is defined as a ≥4-fold rise in the GMT of SARS-CoV-2 binding antibody to the spike protein RBD compared to the pre-vaccine baseline level or from a non-detectable GMT at the baseline to a detectable GMT after fully vaccinated. The proportion of participants with immunogenicity following full vaccination (6 months after last dose) will be described for all enrolled patients and for each disease stratum with 95% CIs. Only patients who provide a viable blood sample to evaluate immunogenicity at these time-points following completion of vaccine series will be included in this estimation.
Time frame: 6 months after the last vaccine dose
Mean and median antibodies response to COVID-19 vaccination in immunocompromised patients at day 0, second dose, third dose, post last dose (day 180).
Antibody level at each time point will be summarized with mean with standard deviation and median with range. Linear mixed effect models will be used to assess the longitudinal pattern, with appropriate data transformation if necessary.
Time frame: 6 months after the last vaccine dose
Mean and median T cell response to COVID-19 vaccination in immunocompromised patients at day 0, second dose, third dose and post last dose (day 180).
T-cell response at each time point will be summarized with mean with standard deviation and median with range. Linear mixed effect models will be used to assess the longitudinal pattern, with appropriate data transformation if necessary.
Time frame: 6 months after the last vaccine dose
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