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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
Exploratory Objectives
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after the last vaccine dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after the last vaccine dose |
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Inclusion Criteria:
Patient receiving care at St. Jude Children's Hospital or Le Bonheur Children's Hospital
Less than 24 years old at the time of enrollment (Day 0)
Planning to receive a COVID-19 vaccine as part of clinical care
Patient is one of the following:
Willing and able to provide informed consent
Exclusion Criteria:
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Those who meet the Eligibility Criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Diego Hijano, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Le Bonheur | Memphis | Tennessee | 38103 | United States | ||
| LeBonheur |
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| Label | URL |
|---|---|
| St.Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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| 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. | 6 months after the last vaccine dose |
| Memphis |
| Tennessee |
| 38103 |
| United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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