CancerNCT05164016
Evaluating Immune Response to COVID-19 Vaccines in Patients With Cancer, Transplant or Cellular Therapy Recipients
An observational study of Cancer and Hematopoietic System--Cancer, run by St. Jude Children's Research Hospital at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 years
- Conditions the study is for
- Cancer, Hematopoietic System--Cancer, Transplant-Related Cancer
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Jun 2022to 9 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Those who meet the Eligibility Criteria.
Who may be able to join
- 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:
- Diagnosed with a Hematological Malignancy (Group A), or
- Received a hematopoietic cell transplant or cellular therapy (Group B), or
Show all 10Show fewer
- Diagnosed with a solid tumor malignancy (Group C).
- Received a solid organ transplant (Group D), or
- Does not have cancer and has not received any type of transplant (Group E)
- Willing and able to provide informed consent
Who cannot join
- Received a COVID-19 vaccine prior to enrollment (Day 0).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Le Bonheur
Memphis, Tennessee, 38103
LeBonheur
Memphis, Tennessee, 38103
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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
Read more
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.
Read the detailed description
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.
- Conditions
- Cancer, Hematopoietic System--Cancer, Transplant-Related Cancer, Solid Tumor Malignancy, Hematologic Malignancy, Solid Organ Transplant
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after the last vaccine dose
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6 months after the last vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start29 Jun 2022
- Primary completion1 May 2025
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diego Hijano, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164016
- Sponsor's protocol ID
- COVVIR
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2021
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Immune Response to COVID-19 Vaccines in Patients With Cancer, Transplant or Cellular Therapy Recipients
- ClinicalTrials.gov ID
- NCT05164016
- Acronym / sponsor ID
- COVVIR
- Conditions
- Cancer, Hematopoietic System--Cancer, Transplant-Related Cancer, Solid Tumor Malignancy, Hematologic Malignancy, Solid Organ Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Those who meet the Eligibility Criteria.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- Received a COVID-19 vaccine prior to enrollment (Day 0).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of participants with immunogenicity following full vaccination (6 months after last dose).
Time frame: 6 months after the last vaccine 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.
2 secondary outcomes
Mean and median antibodies response to COVID-19 vaccination in immunocompromised patients at day 0, second dose, third dose, post last dose (day 180).
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).
Time frame: 6 months after the last vaccine dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- St.Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego Hijano, MD principal investigator
St. Jude Children's Research Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Hematopoietic System--Cancer, run by St. Jude Children's Research Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with immunogenicity following full vaccination (6 months after last dose). (time frame: 6 months after the last vaccine dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.