Efficacy and Safety of COVID-19 Vaccine in Cancer Patients

Mayo Clinic

Status: Completed

Conditions: Malignant Solid Neoplasm; COVID-19 Infection

Treatments: Procedure: Biospecimen Collection; Other: Electronic Health Record Review

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04865133

21-001818 (Other Identifier)

NCI-2021-03137 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

89 participants in 1 patient group

Observational (biospecimen collection, medical record)

Description:

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.

Treatment:

Other: Electronic Health Record Review

Procedure: Biospecimen Collection