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NCT05164016 · ClinicalTrials.gov registry record
Evaluating Immune Response to COVID-19 Vaccines in Patients With Cancer, Transplant or Cellular Therapy Recipients
A clinical trial of Cancer and Hematologic Malignancy, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- 21
- Enrollment target
- 3
- Study locations
NCT05164016: Active study of Cancer and Hematologic Malignancy, sponsored by St. Jude Children's Research Hospital.
NCT05164016 is a study of Cancer and Hematologic Malignancy that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 21 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05164016, a study of Cancer and Hematologic Malignancy, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- 21 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Primary Outcome
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 e
Conditions Studied
Study Locations (3)
Tennessee
- Le Bonheur - Memphis
- LeBonheur - Memphis
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2022-06-29 |
| Est. Completion | 2027-12-31 |
What the registry record for NCT05164016 still lists
NCT05164016 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower).
The record links to 8 conditions, with Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT05164016 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT05164016 about?
NCT05164016 is a clinical study titled "Evaluating Immune Response to COVID-19 Vaccines in Patients With Cancer, Transplant or Cellular Therapy Recipients". 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...
What is the current status of trial NCT05164016?
This trial is currently active not recruiting. The enrollment target is 21 participants. The study started on 2022-06-29. Estimated completion is 2027-12-31.
What conditions does trial NCT05164016 study?
This clinical trial studies the following conditions: Cancer, Hematologic Malignancy, Hematopoietic Cell Transplant, Solid Organ Transplant, Hematopoietic System--Cancer.
Who is sponsoring clinical trial NCT05164016?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05164016 being conducted?
This trial has 3 study locations across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05164016's enrollment target sits among peer trials
21 558th of 615 higher than 56 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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