Status:
COMPLETED
Efficacy and Safety of COVID-19 Vaccine in Cancer Patients
Lead Sponsor:
Mayo Clinic
Conditions:
COVID-19 Infection
Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Brief 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 ...
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 incide...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 8 2022
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT04865133
Start Date
March 31 2021
End Date
September 8 2022
Last Update
December 10 2024
Active Locations (1)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980