Efficacy and Safety of COVID-19 Vaccine in Cancer Patients
Study Details
Study Description
Brief Summary
This early phase I study gathers information about how the body 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 vaccination), prior to second vaccination, 1, 6, and 12 months after the last vaccination. Patients who receive the types of COVID-19 vaccines that do not require the second injection omit the blood sample collection prior to the second vaccination. For patients who have already received COVID-19 vaccines, medical records are reviewed retrospectively.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observational (biospecimen collection, medical record) Patients undergo blood sample collection at baseline (prior to first vaccination), prior to second vaccination, 1, 6, and 12 months after the last vaccination. Patients who receive the types of COVID-19 vaccines that do not require the second injection omit the blood sample collection prior to the second vaccination. For patients who have already received COVID-19 vaccines, medical records are reviewed retrospectively. |
Procedure: Biospecimen Collection
Undergo blood sample collection
Other: Electronic Health Record Review
Medical record reviewed
|
Outcome Measures
Primary Outcome Measures
- Antibody response to COVID-19 vaccine after vaccination in cancer patients and health individuals [Up to 12 months]
Antibody response will be evaluated using Elecsys Anti-SARS-CoV-2 Spike antibody test. Wilcoxon rank sum test will be used to compared between baseline and other 3 time points (before the second vaccination, 3 months, and 12 months after the second vaccination).
Secondary Outcome Measures
- Adverse events of COVID-19 vaccines in cancer patients [Up to 12 months]
Adverse events will be described using descriptive statistics. Adverse events (AEs) will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Complete blood count (CBC) with 5 parts differential and complete metabolic panel per standard of care will be collected if available within 3 months prior to the 1st vaccination until 3 months after the 2nd vaccine.
- Adverse events of COVID-19 vaccines in health individuals [Up to 12 months]
Adverse events will be described using descriptive statistics. Adverse events (AEs) will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Complete blood count (CBC) with 5 parts differential and complete metabolic panel per standard of care will be collected if available within 3 months prior to the 1st vaccination until 3 months after the 2nd vaccine.
- T cell response to COVID-19 vaccine after vaccination in cancer patients [Up to 12 months]
T cell response will be measured with ELISpot
- T cell response to COVID-19 vaccine after vaccination in healthy individuals [Up to 12 months]
T cell response will be measured with ELISpot
Other Outcome Measures
- Incidence of COVID-19 infection after the vaccination in cancer patients [Up to 12 months]
Incidence of COVID 19 infection will be described using description statistics.
- Severity of COVID-19 infection after the vaccination in cancer patients [Up to 12 months]
Severity of COVID19 infection will be assessed, including the rate of hospitalization, use of remdesivir, steroid, other treatment modalities, ICU stay, intubation, mortality, and development of complications such as thrombosis, respiratory failure, and/or multiorgan failure.
- Incidence of COVID-19 infection after the vaccination in healthy individuals [Up to 12 months]
Incidence of COVID 19 infection will be described using description statistics.
- Severity of COVID-19 infection after the vaccination in healthy individuals [Up to 12 months]
Severity of COVID19 infection will be assessed, including the rate of hospitalization, use of remdesivir, steroid, other treatment modalities, ICU stay, intubation, mortality, and development of complications such as thrombosis, respiratory failure, and/or multiorgan failure.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Willing to receive COVID-19 vaccination as per standard of care
-
Willing and able to provide research blood samples
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Capable of providing valid informed consent
-
For cancer patient cohort:
-
Male or female age >= 18 years
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Histologically confirmed solid malignancy on or will be starting on systemic cytotoxic chemotherapy
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For healthy individual cohort:
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Male or female age >= 18 years
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No history of active malignancy =< 3 years
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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
Exclusion Criteria:
- 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Florida | Jacksonville | Florida | United States | 32224-9980 |
Sponsors and Collaborators
- Mayo Clinic
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Saranya Chumsri, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-001818
- NCI-2021-03137
- 21-001818
- P30CA015083