Efficacy and Safety of COVID-19 Vaccine in Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Malignant Solid Neoplasm; COVID-19 Infection
• Intervention / Treatment: 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 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 Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

Inclusion Criteria:

• 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

• 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

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Electronic Health Record Review; Medical record reviewed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 12 months
T cell response to COVID-19 vaccine after vaccination in cancer patients and health individuals		Up to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of COVID-19 infection after the vaccination 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 incidence as well as severity of subsequent COVID-19 infection after the vaccination.	Up to 12 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Saranya Chumsri, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Actual): September 8, 2022
• Study Completion (Actual): September 8, 2022

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: 21-001818; NCI-2021-03137 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No