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Efficacy and Safety of COVID-19 Vaccine in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04865133
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : April 29, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Description
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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
COVID-19 Infection Malignant Solid Neoplasm Procedure: Biospecimen Collection Other: Electronic Health Record Review

Detailed Description:

PRIMARY OBJECTIVES:

I. 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
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Study Type : Observational
Estimated Enrollment : 1070 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Efficacy and Safety of COVID-19 Vaccine in Cancer Patients
Actual Study Start Date : March 31, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Antibody response to COVID-19 vaccine after vaccination in cancer patients and health individuals [ Time Frame: 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 :
  1. Adverse events of COVID-19 vaccines in cancer patients [ Time Frame: 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.

  2. Adverse events of COVID-19 vaccines in health individuals [ Time Frame: 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.

  3. T cell response to COVID-19 vaccine after vaccination in cancer patients [ Time Frame: Up to 12 months ]
    T cell response will be measured with ELISpot

  4. T cell response to COVID-19 vaccine after vaccination in healthy individuals [ Time Frame: Up to 12 months ]
    T cell response will be measured with ELISpot


Other Outcome Measures:
  1. Incidence of COVID-19 infection after the vaccination in cancer patients [ Time Frame: Up to 12 months ]
    Incidence of COVID 19 infection will be described using description statistics.

  2. Severity of COVID-19 infection after the vaccination in cancer patients [ Time Frame: 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.

  3. Incidence of COVID-19 infection after the vaccination in healthy individuals [ Time Frame: Up to 12 months ]
    Incidence of COVID 19 infection will be described using description statistics.

  4. Severity of COVID-19 infection after the vaccination in healthy individuals [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • Willing to receive COVID-19 vaccination as per standard of care
  • 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

  • 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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04865133


Locations
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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224-9980
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Saranya Chumsri, M.D.         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Saranya Chumsri Mayo Clinic
More Information
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT04865133    
Other Study ID Numbers: 21-001818
NCI-2021-03137 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
21-001818 ( Other Identifier: Mayo Clinic in Florida )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases