Efficacy and Safety of COVID-19 Vaccine in Cancer Patients

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    1070
  • sponsor
    Mayo Clinic
Updated on 24 April 2022
Accepts healthy volunteers

Summary

This early phase I study gathers information about how the body 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 vaccination), prior to second vaccination, 1, 6, and 12 months after the last vaccination. Patients who receive the types of COVID-19 vaccines that do not require the second injection omit the blood sample collection prior to the second vaccination. For patients who have already received COVID-19 vaccines, medical records are reviewed retrospectively.

Details
Condition COVID-19 Infection, Malignant Solid Neoplasm
Treatment biospecimen collection, Electronic Health Record Review
Clinical Study IdentifierNCT04865133
SponsorMayo Clinic
Last Modified on24 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Willing to receive COVID-19 vaccination as per standard of care
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
NOTE: If there is a history of prior solid tumor malignancy, it must have been treated curatively with no evidence of recurrence =< 3 years
required prior to study entry) or carcinoma-in-situ of the cervix

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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