Efficacy and Safety of COVID-19 Vaccine in Cancer Patients
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 21-001818
NCT ID: NCT04865133
Sponsor Protocol Number: 21-001818
About this study
We hypothesize that cancer patients on cytotoxic chemotherapy which affect immune response may not mount adequate immune response to COVID-19 vaccines.
Aims, purpose, or objectives:
- To determine the antibody response to COVID-19 vaccine after vaccination.
- To assess the adverse events of COVID-19 vaccines in cancer patients.
- To determine the incidence and severity of COVID-19 infection after the vaccination.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 COVID-19 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.
Exclusion Criteria:
- Immunocompromised patients including patients known to be HIV positive or those on immunosuppressive therapy other than chemotherapy in the judgment of the investigator.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available