Efficacy and Safety of COVID-19 Vaccine in Cancer Patients

Malignant Solid Neoplasm Clinical Trial

Official title:

Efficacy and Safety of COVID-19 Vaccine in Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04865133
• Other study ID #: 21-001818
• Secondary ID: NCI-2021-03137
• Status: Active, not recruiting
• Start date: March 31, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 an immune response will last compared to healthy individuals.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Infection
• Malignant Solid Neoplasm

Intervention

Procedure:
• Biospecimen Collection
Undergo blood sample collection

Other:
• Electronic Health Record Review
Medical record reviewed

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	T cell response to COVID-19 vaccine after vaccination in cancer patients and health individuals		Up to 12 months

External Links

•   Mayo Clinic Clinical Trials