COVID-19 InfectionNCT04865133
Efficacy and Safety of COVID-19 Vaccine in Cancer Patients
An observational study of COVID-19 Infection and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
This study gathers information about how a cancer patient responds to COVID-19 vaccine during cancer treatment compared to healthy individuals. The information gained may help determine how effective currently available COVID-19 vaccines are in cancer patients receiving chemotherapy and learn more regarding how long… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Infection, Malignant Solid Neoplasm
- What is being tested?
- Biospecimen Collection and Electronic Health Record Review
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2021to 8 Sep 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with cancer on or will be starting on systemic cytotoxic chemotherapy for their cancer and healthy individuals who will receive COVID-19 vaccine
Who may be able to join
- Willing to receive COVID-19 vaccination as per standard of care or has already received one or both COVID-19 vaccine injections as long as it has not been longer than three months since their second injection (or the only injection if they receive the types of COVID019 vaccines that do not require the second injection)
- Willing and able to provide research blood samples
- Capable of providing valid informed consent
- For cancer patient cohort:
- Male or female age >= 18 years
- Histologically confirmed solid malignancy on or will be starting on systemic cytotoxic chemotherapy
Show all 15Show fewer
- For healthy individual cohort:
- Male or female age >= 18 years
- No history of active malignancy =< 3 years
- EXCEPTIONS: Adequately treated non-melanotic skin cancer (adequate wound healing is required prior to study entry) or carcinoma-in-situ of the cervix
- NOTE: If there is a history of prior solid tumor malignancy, it must have been treated curatively with no evidence of recurrence =< 3 years
- PATIENTS WITH PREVIOUS COVID-19 INFECTION: Willing and able to provide research blood samples
- PATIENTS WITH PREVIOUS COVID-19 INFECTION: Capable of providing valid informed consent
- PATIENTS WITH PREVIOUS COVID-19 INFECTION: Male or female age >= 18 years
- PATIENTS WITH PREVIOUS COVID-19 INFECTION: Previous history of COVID-19 infection with positive SARS-CoV-2 ribonucleic acid (RNA) by polymerase chain reaction (PCR) or anti-SARS-CoV-2 nucleocapsid antibody
Who cannot join
- Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on immunosuppressive therapy other than chemotherapy in the judgment of the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
About this study
This study gathers information about how a cancer patient responds to COVID-19 vaccine during cancer treatment compared to healthy individuals. The information gained may help determine how effective currently available COVID-19 vaccines are in cancer patients receiving chemotherapy and learn more regarding how long an immune response will last compared to healthy individuals.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the antibody response to COVID-19 vaccine after vaccination. II. To assess the adverse events of COVID-19 vaccines in cancer patients. III. To determine the incidence and severity of COVID-19 infection after the vaccination.
OUTLINE:
Patients undergo blood sample collection at baseline (prior to first COVID-19 vaccination), prior to second vaccination, 1, 6, and 12 months after the last vaccination. Patients receiving a booster vaccine will undergo blood collection prior to and 1-3 months after vaccination. Patients who receive the types of COVID-19 vaccines that do not require the second injection skip blood sample collection at this time point. This study will collect information regarding the type of COVID-19 vaccine received, date of vaccine injection, and any side effects associated with the COVID-19 vaccine that trial participant encountered. This study will also review the medical record for outcomes and information related to the blood testing.
- Conditions
- COVID-19 Infection, Malignant Solid Neoplasm
- Being tested
- Biospecimen Collection, Electronic Health Record Review
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Electronic Health Record ReviewOther
Medical record reviewed
| Study group | Role | What they receive |
|---|---|---|
| Observational (biospecimen collection, medical record) | Patients undergo blood sample collection at baseline (prior to first COVID-19 vaccination), prior to second vaccination, 1, 6, and 12 months after the last vaccination. Patients receiving a booster vaccine will undergo blood collection prior to and 1-3 months after vaccination. Patients who receive the types of COVID-19 vaccines that do not require the second injection skip blood sample collection at this time point. This study will collect information regarding the type of COVID-19 vaccine received, date of vaccine injection, and any side effects associated with the COVID-19 vaccine that trial participant encountered. This study will also review the medical record for outcomes and information related to the blood testing. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody response to COVID-19 vaccine after vaccination in cancer patients and health individuals
Wilcoxon rank sum test will be used to compare between baseline and other 3 time points (before the second vaccination, 3 months, and 12 months after the second vaccination).
Measured: Up to 12 months
Secondary outcomes (2)
Adverse events of COVID-19 vaccines in cancer patients and health individuals
Will use descriptive statistics (mean, median, range for continuous variables and frequency/percentage for categorical variables) to analyze demographic data including age, ethnicity, and comorbidity in healthy individuals and cancer patients as well as cancer type and current cancer treatment in cancer patients in association with adverse events after the vaccination.
Measured: Up to 12 months
T cell response to COVID-19 vaccine after vaccination in cancer patients and health individuals
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start31 Mar 2021
- Primary completion8 Sep 2022
- Study completion8 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Case only
- Time perspective
- Other
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saranya Chumsri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865133
- Sponsor's protocol ID
- 21-001818
- Other IDs
- NCI-2021-03137
- Status last verified
- Dec 2024
- First submitted
- 22 Apr 2021
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of COVID-19 Vaccine in Cancer Patients
- ClinicalTrials.gov ID
- NCT04865133
- Acronym / sponsor ID
- 21-001818
- Conditions
- COVID-19 Infection, Malignant Solid Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 8 Sep 2022 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 29 Apr 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 gathers information about how a cancer patient responds to COVID-19 vaccine during cancer treatment compared to healthy individuals. The information gained may help determine how effective currently available COVID-19 vaccines are in cancer patients receiving chemotherapy and learn more regarding how long an immune response will last compared to healthy individuals.
Detailed description
PRIMARY OBJECTIVES:
- To determine the antibody response to COVID-19 vaccine after vaccination. II. To assess the adverse events of COVID-19 vaccines in cancer patients. III. To determine the incidence and severity of COVID-19 infection after the vaccination.
OUTLINE:
Patients undergo blood sample collection at baseline (prior to first COVID-19 vaccination), prior to second vaccination, 1, 6, and 12 months after the last vaccination. Patients receiving a booster vaccine will undergo blood collection prior to and 1-3 months after vaccination. Patients who receive the types of COVID-19 vaccines that do not require the second injection skip blood sample collection at this time point. This study will collect information regarding the type of COVID-19 vaccine received, date of vaccine injection, and any side effects associated with the COVID-19 vaccine that trial participant encountered. This study will also review the medical record for outcomes and information related to the blood testing.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (biospecimen collection, medical record) | – | Procedure: Biospecimen Collection, Other: Electronic Health Record ReviewPatients undergo blood sample collection at baseline (prior to first COVID-19 vaccination), prior to second vaccination, 1, 6, and 12 months after the last vaccination. Patients receiving a booster vaccine will undergo blood collection prior to and 1-3 months after vaccination. Patients who receive the types of COVID-19 vaccines that do not require the second injection skip blood sample collection at this time point. This study will collect information regarding the type of COVID-19 vaccine received, date of vaccine injection, and any side effects associated with the COVID-19 vaccine that trial participant encountered. This study will also review the medical record for outcomes and information related to the blood testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with cancer on or will be starting on systemic cytotoxic chemotherapy for their cancer and healthy individuals who will receive COVID-19 vaccine
Key inclusion criteria (15 listed)
- Willing to receive COVID-19 vaccination as per standard of care or has already received one or both COVID-19 vaccine injections as long as it has not been longer than three months since their second injection (or the only injection if they receive the types of COVID019 vaccines that do not require the second injection)
- Willing and able to provide research blood samples
- Capable of providing valid informed consent
- For cancer patient cohort:
- For healthy individual cohort:
Key exclusion criteria (1 listed)
- Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on immunosuppressive therapy other than chemotherapy in the judgment of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Observational (biospecimen collection, medical record) |
| Electronic Health Record ReviewMedical record reviewed | Other | Observational (biospecimen collection, medical record) |
Primary outcome
Antibody response to COVID-19 vaccine after vaccination in cancer patients and health individuals
Time frame: Up to 12 months
Wilcoxon rank sum test will be used to compare between baseline and other 3 time points (before the second vaccination, 3 months, and 12 months after the second vaccination).
2 secondary outcomes
Adverse events of COVID-19 vaccines in cancer patients and health individuals
Time frame: Up to 12 months
T cell response to COVID-19 vaccine after vaccination in cancer patients and health individuals
Time frame: Up to 12 months
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 10 Dec 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Saranya Chumsri, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Infection and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site 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 15 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 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Antibody response to COVID-19 vaccine after vaccination in cancer patients and health individuals (time frame: Up to 12 months). 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 10 Dec 2024.