Clinical trial · Observational
Evaluating Immune Response to COVID-19 Vaccines in Patients With Cancer, Transplant or Cellular Therapy Recipients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cellular Therapy | — | UNRESOLVED | — |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Hematopoietic Cell Transplant | — | UNRESOLVED | — |
| Hematopoietic System--Cancer | — | UNRESOLVED | — |
| Solid Organ Transplant | — | UNRESOLVED | — |
| Solid Tumor Malignancy | — | UNRESOLVED | — |
| Transplant-Related Cancer | Transplant-Related Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Proportion of participants with immunogenicity following full vaccination (6 months after last dose).
- timeFrame
- 6 months after the last vaccine dose
- description
- 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.
Secondary outcomes (2)
- measure
- Mean and median antibodies response to COVID-19 vaccination in immunocompromised patients at day 0, second dose, third dose, post last dose (day 180).
- timeFrame
- 6 months after the last vaccine dose
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 24 Years
Show eligibility criteria text
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: 1. Diagnosed with a Hematological Malignancy (Group A), or 2. Received a hematopoietic cell transplant or cellular therapy (Group B), or 3. Diagnosed with a solid tumor malignancy (Group C). 4. Received a solid organ transplant (Group D), or 5. Does not have cancer and has not received any type of transplant (Group E) * Willing and able to provide informed consent Exclusion Criteria: * Received a COVID-19 vaccine prior to enrollment (Day 0).
References
Publications (0)
Data not yet available